Ulcerative ColitisBOOST-UCNCT06906445
A Study to Evaluate the Effect of Fecal Transplant and Dietary Changes on Disease Activity in Patients With Ulcerative Colitis on Advanced Therapies
A study testing Fecal Microbial Transplantation, Anti-Inflammatory Diet and Advanced Therapy in people with Ulcerative Colitis, run by All India Institute of Medical Sciences at 6 sites in India.
Trial summary
Ulcerative colitis (UC) is a chronic inflammatory disease of the colon characterized by superficial mucosal inflammation. Treatment aims to achieve and maintain remission, improve quality of life, and minimize complications. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Fecal Microbial Transplantation, Anti-Inflammatory Diet and Advanced Therapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 6 sitesIndia
- Study dates
- 15 Mar 2025to 15 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (age 18 to 75 years) patients
- Patients with active UC (defined as mMS equal or greater than 3 with rectal bleed score equal or greater than 1 and Endoscopic Mayo score equal or greater than 2 documented within 3 months of randomization or mild symptoms with high inflammatory burden or poor prognostic features).
- Any disease extent E1, E2 or E3. Patients with Proctitis will be limited to 25 percent of the entire pool of patients.
- Patients with an inadequate response, loss of response, or intolerance to conventional therapies example, aminosalicylates, corticosteroids, immunosuppressants or advanced therapies including but not limited to anti TNF alpha agents, anti-integrins, anti IL 12 or IL 23 agents, anti IL 23 agents, JAK inhibitors, or S1P receptor modulators. The last administration of any such treatment must have occurred at least five half-lives prior to randomization.
- Confirmed diagnosis of UC. The diagnosis must be confirmed by endoscopic and histologic evidence and corroborated by a histopathology report
- Subjects who are willing and able to comply with treatment plan, laboratory tests, daily bowel movement diary call and other study procedures
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- Subjects who are willing to provide a written informed consent for FMT
- Agree to adhere to the diet schedule
- Infective colitis ruled out Biopsy showing crypt architecture distortion or basal plasmacytosis, OR two sigmoidoscopies, at least 7 days apart showing evidence of endoscopic activity
Who cannot join
- Hospitalization of exacerbation of UC requiring intravenous corticosteroids
- Patients already on biologics (anti-tumor necrosis factor inhibitors) or small molecules (tofacitinib) for equal or more than 2 weeks.
- Clinical signs of fulminant colitis or toxic megacolon
- Positive assay or stool culture for pathogens (ova and parasite examination, bacteria) or positive test for Clostridioides difficile toxin or CMV (histology or IHC and or tissue PCR) at screening. (The patients with positive assay will be treated appropriately and tests will be repeated. Those with negative assay and persistent activity will be included in the study.)
- Active or inadequately treated infections, including Mycobacterium tuberculosis.
- Presence of IBD-unclassified, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohn's Disease.
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- Patients infected with human immunodeficiency virus (HIV)
- Patients with current or past history of malignancy.
- Patients with current or recent history of clinically severe, progressive, or uncontrolled renal, hepatic, Hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac, or neurological disease.
- Pregnant females
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
India6 sites, 6 recruiting
- Not yet recruiting
Department of Gastroentrology, Postgraduate Institute of Medical Education and Research,
Chandigarh, Punjab/Haryana
Dr Vishal Sharma, DM Gastroenterology, +91-8872813399, docvishalsharma@gmail.com
Dr Vishal Sharma, DM Gastroenterology
- Not yet recruiting
Department of Gastroenterology, Lisie Hospital
Kochi, Kerala
Dr Mathew Philip, DM Gastroenterology, +91-9846045469
Dr Kiran Josy, DM Gastroenterology, +91-9745243939, drkiranjosy@gmail.com
- Not yet recruiting
Department of Gastroenterology, Dayanand Medical College
Ludhiana, Punjab, DR AJIT SOOD
Prof Ajit Sood, DM Gastroenterology, +91-9815400718, ajitsood10@gmail.com
Dr Arshdeep Singh, DM Gastroenterology, +91-9815337764, drarshdeepsingh@gmail.com
- Not yet recruiting
Lokmanya Tilak Municipal General Hospital and Lokmanya Tilak Municipal Medical College, Sion
Mumbai, Maharashtra
Dr Sanjay Chandnani, DM Gastroenterology, +91-9049708800, sanjy.med@gmail.com
Dr Sanjay Chandnani, DM Gastroenterology
- Recruiting
Department of Gastroenterology and Human Nutrition, All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, VINEET AHUJA
Prof Vineet Ahuja, DM Gasteroentrology, +91-9810707170, vineet.aiims@gmail.com
Dr Himanshu Narang, DM Gastroentrology, +91-8800316504, h92narang@gmail.com
- Not yet recruiting
Department of Gastroenterology, Institute of Medical Sciences
Varanasi, Uttar Pradesh
Dr Devesh Prakash Yadav, DM Gastroenterology, +91-8130856563, devesh.thedoc@gmail.com
Dr Devesh Prakash Yadav, DM Gastroenterology
About this study
Official title: Efficacy of Microbiome Manipulation Strategies Fecal Microbial Transplant or Anti-inflammatory Diet or Both With Advanced Therapies BiOlOgics and Small Molecules to Break the Therapeutic Ceiling in Active Ulcerative Colitis BOOST-UC A Multicenter Double Blind Factorial Randomized Controlled Trial
Ulcerative colitis (UC) is a chronic inflammatory disease of the colon characterized by superficial mucosal inflammation. Treatment aims to achieve and maintain remission, improve quality of life, and minimize complications. Advanced therapies, including biologics and small molecules, have significantly improved UC management by targeting specific inflammatory pathways. However, due to the multifactorial nature of UC-driven by genetic, environmental, and microbial factors-many patients do not achieve sustained remission, highlighting a therapeutic ceiling. Gut microbial dysbiosis and immune dysregulation are central to UC pathogenesis, with diet playing a critical role in influencing the gut microbiome. While biologics and small molecules have limitations, innovative approaches like combining fecal microbiota transplantation (FMT) and dietary interventions with advanced therapies show promise. FMT restores microbial balance, modulates immunity, and reduces inflammation, while dietary modifications, such as anti-inflammatory diets, enhance FMT efficacy by creating a favorable environment for donor microbiota engraftment. The present study is designed to evaluate the efficacy of three different microbiome manipulation strategies- FMT, AID and FMT + AID in combination with advanced therapies in patients with active UC in a 2X2 factorial trial design. Patients would be randomized into four different arms: FMT, AID, FMT+AID and placebo. The advanced therapies (biologics or small molecules) would be given in all four arms as standard therapy. With this design the trial would answer two important questions: a) efficacy of combination treatment with advanced therapies and microbiome manipulation strategies in active UC, and b) comparative efficacy of different microbiome manipulation strategies.
Read the detailed description
This study is a multicenter, randomized, factorial-design, double-blind, controlled trial investigating the effects of fecal microbiota transplantation (FMT) and dietary interventions in patients with mild to moderate, treatment-naïve, active inflammatory bowel disease. The trial is being conducted across multiple clinical centers, with a central microbiome analysis facility.
Randomization and Blinding:
Randomization: Centralized, computerized randomization is employed to ensure balanced treatment allocation. The permuted block method, along with stratification based on disease characteristics, ensures equal distribution across intervention arms Blinding: Patients, investigators collecting clinical data, and endoscopic video assessors are blinded to treatment allocation. The dietitian and endoscopist performing FMT (or sham FMT) are unblinded
Intervention Arms:
Participants are assigned to one of four treatment arms:
FMT + Anti-inflammatory Diet (AID) +Advanced therapy FMT + Sham Diet+ Advanced therapy Sham FMT + AID+ Advanced therapy Sham FMT + Sham Diet+ Advanced therapy FMT is administered via colonoscopy at 0, 2, and 6 weeks, with responders receiving maintenance doses every 8 weeks until week 48
Participant Timeline and Assessments:
Baseline Assessments: Clinical, laboratory, and endoscopic evaluations, including serological tests, inflammatory markers, and microbiome profiling.
Follow-up Schedule: Visits occur at Week 0, Week 6, Week 10, and then every 8 weeks until Week 48.
Endoscopic Monitoring: Colonoscopy is performed at baseline, Week 10, and Week 48. Centralized endoscopic video scoring ensures consistency
Data Collection and Management:
Paper CRF's and Electronic Data: The paper based CRF's will be filled first and then data will be entered into a REDCap software.
Dietary Monitoring: Participants will use the IBD NutriCare mobile application for diet tracking.
Microbiome Analysis: Fecal samples are processed and analyzed at a designated microbiome research center.
Safety Monitoring and Compliance:
Adverse Event Reporting: All safety events, including potential serious adverse events (SAEs), are logged and monitored by the Data and Safety Monitoring Board (DSMB).
Protocol Deviations: Documented and assessed for impact on trial integrity. Training and Quality Control: Regular site training ensures adherence to the protocol, and periodic audits maintain data quality
- Conditions
- Ulcerative Colitis
- Being tested
- Fecal Microbial Transplantation, Anti-Inflammatory Diet, Sham transplantation, Sham Diet, Advanced Therapy
- Keywords
- Randomized Controlled Trial, Fecal Microbial Transplantation, Anti-inflammatory diet, Factorial design, Ulcerative colitis, Advanced therapy
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal Microbial TransplantationOther
This will involve colonoscopic instillation of fecal transplant
Anti-Inflammatory DietOther
The modified diet plan will be given to each study participant
Sham transplantationOther
Sham FMT will involve saline infusion via colonoscopy
Sham DietOther
Dietary counselling alone
Advanced TherapyOther
Advanced therapy as standard dose and schedule
| Study group | Role | What they receive |
|---|---|---|
| Fecal Microbiota Transplantation and Anti inflammatory diet and advanced therapy | Experimental | 1.Oral vancomycin 500 mg BD for 3 days before the first FMT 2.FMT via colonoscopy at 0, 2, and 6 weeks for induction of remission 3.FMT via colonoscopy every 8 weeks (week 10, 18, 26, 34, 42) for maintenance of remission, if the patient is responder to the induction therapy 4.If the patient is a non-responder or has treatment failure to induction, he/she will be withdrawn from the study. 5.Patients with secondary loss of response, in the maintenance phase, will be withdrawn from the study 6.AID for 48 weeks. 7.Advanced therapy as standard dose and schedule Receives: Other: Fecal Microbial Transplantation; Other: Anti-Inflammatory Diet; Other: Advanced Therapy |
| Fecal Microbiota Transplantation and sham diet/standard dietary counselling and advanced therapy | Experimental | 1.Oral vancomycin 500 mg BD for 3 days before the first FMT 2.FMT via colonoscopy at 0, 2, and 6 weeks for induction of remission 3.FMT via colonoscopy every 8 weeks (week 10, 18, 26, 34, 42) for maintenance of remission, if the patient is responder to the induction therapy 4.If the patient is a non-responder or has treatment failure to induction, he/she will be withdrawn from the study. 5.Patients with secondary loss of response, in the maintenance phase, will be withdrawn from the study 6. Sham AID/Standard dietary counseling for 48 weeks. 7. Advanced therapy as standard dose and schedule Receives: Other: Fecal Microbial Transplantation; Other: Sham Diet; Other: Advanced Therapy |
| Sham Transplantation and Anti inflammatory diet and advanced therapy | Experimental | 1.Oral placebo 1 BD for 3 days before first FMT 2.Sham FMT via colonoscopy (instillation of clean water) at 0, 2, and 6 weeks 3.Sham FMT via colonoscopy (instillation of clean water) every 8 weeks (week 10, 18, 26, 34, 42) for maintenance of remission, if the patient is responder to the induction therapy 4.If the patient is a non-responder or has treatment failure to induction therapy, he/she will be withdrawn from the study. 5.Patients with secondary loss of response, in the maintenance phase, will be withdrawn from the study 6. AID for 48 weeks. 7. Advanced therapy as standard dose and schedule. Receives: Other: Anti-Inflammatory Diet; Other: Sham transplantation; Other: Advanced Therapy |
| Sham transplantation and Sham Diet and advanced therapy | Sham comparator | 1.Oral placebo 1 BD for 3 days before first FMT 2. Sham FMT via colonoscopy (instillation of clean water) at 0, 2, and 6 weeks 3. Sham FMT via colonoscopy (instillation of clean water) every 8 weeks (week 10, 18, 26, 34, 42) for maintenance of remission, if the patient is responder to the induction therapy 4. If the patient is a non-responder or has treatment failure to induction therapy, he/she will be withdrawn from the study. 5. Patients with secondary loss of response, in the maintenance phase, will be withdrawn from the study 6. Sham AID/Standard dietary counseling for 48 weeks 7. Advanced therapy as standard dose and schedule Receives: Other: Sham transplantation; Other: Sham Diet; Other: Advanced Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients Achieving Clinical Remission and Endoscopic Response at 10 weeks
Proportion of patients having- 1. Clinical remission which is defined as the Modified Mayo Score (mMS) < 2 \ mMS- Full Title: Modified Mayo Score Range: 0 to 12 Higher Scores = Worse Outcome (A score of 0 represents no disease activity, and a score of 12 represents the most severe disease activity.) 2. Endoscopic response which is defined as Mayo Endoscopic Score (MES) by 1 point MES- Full Title: Mayo Endoscopic Score Range: 0 to 4 Higher Scores = Worse Outcome (A score of 0 represents normal endoscopic findings, and a score of 4 represents severe mucosal damage.
Measured: 10 weeks
Proportion of patients having clinical remission and endoscopic remission at week 48
Proportion of patients having- 1. Clinical remission which is defined as the Modified Mayo Score (mMS) < 2 mMS- Full Title: Modified Mayo Score Range: 0 to 12 Higher Scores = Worse Outcome (A score of 0 represents no disease activity, and a score of 12 represents the most severe disease activity.) 2. Endoscopic response which is defined as Mayo Endoscopic Score (MES) by 1 point MES- Full Title: Mayo Endoscopic Score Range: 0 to 4 Higher Scores = Worse Outcome (A score of 0 represents normal endoscopic findings, and a score of 4 represents severe mucosal damage.
Measured: 48 weeks
Secondary outcomes (24)
Proportion of patients having clinical response at week 10
Proportion of patients having clinical response (Defined as a decrease from baseline in the mMS of greater than or equal to 2 points and at least a 30 percent reduction from baseline) mMS- Full Title: Modified Mayo Score Range: 0 to 12 Higher Scores = Worse Outcome (A score of 0 represents no disease activity, and a score of 12 represents the most severe disease activity.)
Measured: 10 weeks
Proportion of patients having clinical remission at week 10
Proportion of patients having clinical remission which is defined as an mMS of 0 to 2, including the following three components: 1) Stool frequency sub score = 0 (or = 1 with a ≥ 1-point decrease from baseline), 2) Rectal bleeding sub score = 0 3) Centrally read endoscopy sub score = 0 or 1 (score of 1 modified to exclude friability) mMS- Full Title: Modified Mayo Score Range: 0 to 12 Higher Scores = Worse Outcome (A score of 0 represents no disease activity, and a score of 12 represents the most severe disease activity.)
Measured: 10 weeks
Proportion of Patients achieving Symptomatic Response at Week 10
Proportion of Patients Achieving Symptomatic Response which is defined as Decrease from baseline ≥ 30% in composite Rectal Bleeding sub score and Stool Frequency sub score and a ≥ 1-point decrease from baseline in RB sub score or an absolute RB sub score ≤ 1) Stool Frequency Subscore: Range: 0 to 3 (typically; the exact range may vary depending on the scale used) Lower Scores = Better Outcome (A score of 0 indicates no stool frequency issues, while higher scores represent increasing frequency of stools, indicating worse disease activity.) Rectal Bleeding Subscore: Range: 0 to 3 (typically; range may vary depending on the version used) Lower Scores = Better Outcome (A score of 0 indicates no rectal bleeding, while higher scores represent increasing severity of rectal bleeding, indicating worse disease activity.)
Measured: 10 weeks
Proportion of Patients achieving Symptomatic Remission at week 10
Proportion of Patients achieving Symptomatic Remission which is defined as Stool Frequency subscore = 0 (or = 1 with a ≥ 1-point decrease from baseline) and Rectal Bleeding subscore = 0 Stool Frequency Subscore: Range: 0 to 3, Lower Scores = Better Outcome (A score of 0 indicates no stool frequency issues, while higher scores represent increasing frequency of stools, indicating worse disease activity.) Rectal Bleeding Subscore: Range: 0 to 3, Lower Scores = Better Outcome (A score of 0 indicates no rectal bleeding, while higher scores represent increasing severity of rectal bleeding, indicating worse disease disease activity.) Rectal Bleeding Subscore: Range: 0 to 3, Lower Scores = Better Outcome (A score of 0 indicates no rectal bleeding, while higher scores represent increasing severity of rectal bleeding, indicating worse disease activity.)
Measured: 10 weeks
Proportion of Patients Achieving Endoscopic Response at Week 10
Proportion of Patients Achieving Endoscopic Response which is defined as decrease in Modified Endoscopic Score ≥1 points MES- Full Title: Mayo Endoscopic Score Range: 0 to 4 Higher Scores = Worse Outcome (A score of 0 represents normal endoscopic findings, and a score of 4 represents severe mucosal damage.
Measured: 10 weeks
Proportion of Patients Achieving Endoscopic Remission at Week 10
Proportion of Patients achieving Endoscopic Remission which is defined as Modified Endoscopy Score=0 MES- Full Title: Mayo Endoscopic Score Range: 0 to 4 Higher Scores = Worse Outcome (A score of 0 represents normal endoscopic findings, and a score of 4 represents severe mucosal damage.
Measured: 10 weeks
Proportion of Patients Achieving Histologic Remission at Week 10
Proportion of Patients Achieving Histologic Remission (Robarts histopathology index score <3 with lamina propria neutrophils score = 0 and neutrophil in epithelium score=0; DCA (Distribution/ chronicity/ activity) score, A=0) Robarts Histopathology Index (RHI): Full Title: Robarts Histopathology Index Range: 0 to 16 (varies depending on the specific version used, but typically it is in this range) Lower Scores = Better Outcome (A lower score indicates less histologic damage or inflammation.) Lamina Propria Neutrophils Score: Range: 0 to 3 Lower Scores = Better Outcome (A score of 0 indicates no neutrophils present, which is a sign of histologic remission.) Neutrophils in Epithelium Score: Range: 0 to 3 Lower Scores = Better Outcome (A score of 0 indicates no neutrophils in the epithelium, which is also a sign of histologic remission.) DCA Score: Full Title: Distribution/Chronicity/Activity Score Range: 0 to 3 Lower Scores = Better Outcome (score of 0 =no activity
Measured: 10 weeks
Proportion of Patients Achieving Biomarker Remission at Week 10
Proportion of Patients Achieving Biomarker Remission (Defined as fecal calprotectin ≤150 mcg/g) at Week 10
Measured: 10 weeks
Proportion of Patients Experiencing Adverse Events at Week 10
Proportion of Patients experiencing Adverse events which will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) and graded as follows: Grade 1: Mild symptoms (no intervention required). Grade 2: Moderate symptoms (non-operative intervention required). Grade 3: Severe symptoms (operative intervention required). Grade 4: Life-threatening consequences (urgent intervention required). Grade 5: Death.
Measured: 10 weeks
Fecal Microbiome and Metabolite Signature at Week 10
It involves combined analysis of the microorganisms (bacteria, viruses, fungi, etc.) and the small molecules (metabolites) present in a person's stool sample
Measured: 10 weeks
Dynamics of microbiome engraftment at week 10
It involves capturing donor-to-recipient microbiome transfer/shift at species and strain-level will be performed as an investigation of 'FMT events', where in each event will include triad of samples: the donor, the Pre-FMT and the Post-FMT sample from the recipient patient. Species-level donor-to-recipient shifts will be investigated by computing the Bray-Curtis and Kendall distances between all three sample-pairs of the triad. Kendall distances capture the variations and similarities amongst samples in terms of the relative hierarchical ranking of different taxa within a community, Bray-Curtis distances capture the differences in the abundances of different taxa across two communities. Both these distance measure-based approaches will be utilized the fraction of recipient microbiome that is modulated by the donor microbiome in terms of both composition and species-level hierarchy.
Measured: 10 weeks
Proportion of patients having clinical response at week 48
Proportion of patients having clinical response (Defined as a decrease from baseline in the mMS of greater than or equal to 2 points and at least a 30 percent reduction from baseline) mMS- Full Title: Modified Mayo Score Range: 0 to 12 Higher Scores = Worse Outcome (A score of 0 represents no disease activity, and a score of 12 represents the most severe disease activity.)
Measured: 48 weeks
Proportion of patients having clinical remission at week 48
Proportion of patients having clinical remission which is defined as an modified mayo score of 0 to 2, including the following three components: 1) Stool frequency sub score = 0 (or = 1 with a ≥ 1-point decrease from baseline), 2) Rectal bleeding sub score = 0 3) Centrally read endoscopy sub score = 0 or 1 (score of 1 modified to exclude friability) mMS- Full Title: Modified Mayo Score Range: 0 to 12 Higher Scores = Worse Outcome (A score of 0 represents no disease activity, and a score of 12 represents the most severe disease activity.)
Measured: 48 weeks
Proportion of Patients Achieving Symptomatic Response at Week 48
Proportion of Patients Achieving Symptomatic Response which is defined as Decrease from baseline ≥ 30% in composite Rectal Bleeding sub score and Stool Frequency sub score and a ≥ 1-point decrease from baseline in RB sub score or an absolute RB sub score ≤ 1) Stool Frequency Subscore: Range: 0 to 3 (typically; the exact range may vary depending on the scale used) Lower Scores = Better Outcome (A score of 0 indicates no stool frequency issues, while higher scores represent increasing frequency of stools, indicating worse disease activity.) Rectal Bleeding Subscore: Range: 0 to 3 (typically; range may vary depending on the version used) Lower Scores = Better Outcome (A score of 0 indicates no rectal bleeding, while higher scores represent increasing severity of rectal bleeding, indicating worse disease activity.)
Measured: 48 weeks
Proportion of Patients achieving Symptomatic Remission at Week 48
Proportion of Patients achieving Symptomatic Remission which is defined as Stool Frequency subscore = 0 (or = 1 with a ≥ 1-point decrease from baseline) and Rectal Bleeding subscore = 0 Stool Frequency Subscore: Range: 0 to 3 (typically; the exact range may vary depending on the scale used) Lower Scores = Better Outcome (A score of 0 indicates no stool frequency issues, while higher scores represent increasing frequency of stools, indicating worse disease activity.) Rectal Bleeding Subscore: Range: 0 to 3 (typically; range may vary depending on the version used) Lower Scores = Better Outcome (A score of 0 indicates no rectal bleeding, while higher scores represent increasing severity of rectal bleeding, indicating worse disease activity.)
Measured: 48 weeks
Proportion of Patients achieving Endoscopic Response at Week 48
Proportion of Patients Achieving Endoscopic Response which is defined as decrease in Modified Endoscopic Score ≥1 points MES- Full Title: Mayo Endoscopic Score Range: 0 to 4 Higher Scores = Worse Outcome (A score of 0 represents normal endoscopic findings, and a score of 4 represents severe mucosal damage.
Measured: 48 weeks
Proportion of Patients achieving Endoscopic Remission at Week 48
Proportion of Patients achieving Endoscopic Remission which is defined as Modified Endoscopy Score=0 MES- Full Title: Mayo Endoscopic Score Range: 0 to 4 Higher Scores = Worse Outcome (A score of 0 represents normal endoscopic findings, and a score of 4 represents severe mucosal damage.
Measured: 48 weeks
Proportion of Patients achieving Histologic Remission at Week 48
Proportion of Patients Achieving Histologic Remission (Robarts histopathology index score <3 with lamina propria neutrophils score = 0 and neutrophil in epithelium score=0; DCA (Distribution/ chronicity/ activity) score, A=0) Robarts Histopathology Index (RHI): Full Title: Robarts Histopathology Index Range: 0 to 16 (varies depending on the specific version used, but typically it is in this range) Lower Scores = Better Outcome (A lower score indicates less histologic damage or inflammation.) Lamina Propria Neutrophils Score: Range: 0 to 3 Lower Scores = Better Outcome (A score of 0 indicates no neutrophils present, which is a sign of histologic remission.) Neutrophils in Epithelium Score: Range: 0 to 3 Lower Scores = Better Outcome (A score of 0 indicates no neutrophils in the epithelium, which is also a sign of histologic remission.) DCA Score: Full Title: Distribution/Chronicity/Activity Score Range: 0 to 3 Lower Scores = Better Outcome (score of 0 =no activity
Measured: 48 weeks
Proportion of Patients Achieving Biomarker Remission at Week 48
Proportion of Patients Achieving Biomarker Remission (Defined as fecal calprotectin ≤150 mcg/g)
Measured: 48 weeks
Fecal Microbiome and Metabolite Signature at Week 48
It involves combined analysis of the microorganisms (bacteria, viruses, fungi, etc.) and the small molecules (metabolites) present in a person's stool sample
Measured: 48 weeks
Dynamics of microbiome engraftment at week 48
It involves capturing donor-to-recipient microbiome transfer/shift at species and strain-level will be performed as an investigation of 'FMT events', where in each event will include triad of samples: the donor, the Pre-FMT and the Post-FMT sample from the recipient patient. Species-level donor-to-recipient shifts will be investigated by computing the Bray-Curtis and Kendall distances between all three sample-pairs of the triad. Kendall distances capture the variations and similarities amongst samples in terms of the relative hierarchical ranking of different taxa within a community, Bray-Curtis distances capture the differences in the abundances of different taxa across two communities. Both these distance measure-based approaches will be utilized the fraction of recipient microbiome that is modulated by the donor microbiome in terms of both composition and species-level hierarchy.
Measured: 48 weeks
Proportion of Patients Experiencing Adverse Events at Week 48
Proportion of Patients experiencing Adverse events which will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) and graded as follows: Grade 1: Mild symptoms (no intervention required). Grade 2: Moderate symptoms (non-operative intervention required). Grade 3: Severe symptoms (operative intervention required). Grade 4: Life-threatening consequences (urgent intervention required). Grade 5: Death.
Measured: 48 weeks
Proportion of patients having adverse events at week 6
Proportion of Patients experiencing Adverse events which will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) and graded as follows: Grade 1: Mild symptoms (no intervention required). Grade 2: Moderate symptoms (non-operative intervention required). Grade 3: Severe symptoms (operative intervention required). Grade 4: Life-threatening consequences (urgent intervention required). Grade 5: Death.
Measured: 6 weeks
Proportion of patients having adverse events at week 26
Proportion of Patients experiencing Adverse events which will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) and graded as follows: Grade 1: Mild symptoms (no intervention required). Grade 2: Moderate symptoms (non-operative intervention required). Grade 3: Severe symptoms (operative intervention required). Grade 4: Life-threatening consequences (urgent intervention required). Grade 5: Death.
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study start15 Mar 2025
- Primary completion15 Mar 2027 (estimated)
- Study completion15 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Vineet Ahuja, All India Institute of Medical Sciences
- Investigators
- Prof Vineet Ahuja, DM Gastroenterology, Principal investigator, Department of Gastroenterology, AIIMS, New Delhi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06906445
- Sponsor's protocol ID
- AIIMSA2987/03.01.2025
- Other IDs
- EMDR/CARE/12/2023-0000572
- Acronym
- BOOST-UC
- Status last verified
- Mar 2025
- First submitted
- 3 Mar 2025
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Microbiome Manipulation Strategies Fecal Microbial Transplant or Anti-inflammatory Diet or Both With Advanced Therapies BiOlOgics and Small Molecules to Break the Therapeutic Ceiling in Active Ulcerative Colitis BOOST-UC A Multicenter Double Blind Factorial Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06906445
- Acronym / sponsor ID
- BOOST-UC / AIIMSA2987/03.01.2025
- Conditions
- Ulcerative Colitis
- Keywords
- Randomized Controlled Trial, Fecal Microbial Transplantation, Anti-inflammatory diet, Factorial design, Ulcerative colitis, Advanced therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- All India Institute of Medical SciencesUniversity, hospital or other
- Study start
- 15 Mar 2025 (actual)
- Primary completion
- 15 Mar 2027 (estimated)
- Study completion
- 15 Mar 2028 (estimated)
- First posted
- 2 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Ulcerative colitis (UC) is a chronic inflammatory disease of the colon characterized by superficial mucosal inflammation. Treatment aims to achieve and maintain remission, improve quality of life, and minimize complications. Advanced therapies, including biologics and small molecules, have significantly improved UC management by targeting specific inflammatory pathways. However, due to the multifactorial nature of UC-driven by genetic, environmental, and microbial factors-many patients do not achieve sustained remission, highlighting a therapeutic ceiling. Gut microbial dysbiosis and immune dysregulation are central to UC pathogenesis, with diet playing a critical role in influencing the gut microbiome. While biologics and small molecules have limitations, innovative approaches like combining fecal microbiota transplantation (FMT) and dietary interventions with advanced therapies show promise. FMT restores microbial balance, modulates immunity, and reduces inflammation, while dietary modifications, such as anti-inflammatory diets, enhance FMT efficacy by creating a favorable environment for donor microbiota engraftment. The present study is designed to evaluate the efficacy of three different microbiome manipulation strategies- FMT, AID and FMT + AID in combination with advanced therapies in patients with active UC in a 2X2 factorial trial design. Patients would be randomized into four different arms: FMT, AID, FMT+AID and placebo. The advanced therapies (biologics or small molecules) would be given in all four arms as standard therapy. With this design the trial would answer two important questions: a) efficacy of combination treatment with advanced therapies and microbiome manipulation strategies in active UC, and b) comparative efficacy of different microbiome manipulation strategies.
Detailed description
This study is a multicenter, randomized, factorial-design, double-blind, controlled trial investigating the effects of fecal microbiota transplantation (FMT) and dietary interventions in patients with mild to moderate, treatment-naïve, active inflammatory bowel disease. The trial is being conducted across multiple clinical centers, with a central microbiome analysis facility.
Randomization and Blinding:
Randomization: Centralized, computerized randomization is employed to ensure balanced treatment allocation. The permuted block method, along with stratification based on disease characteristics, ensures equal distribution across intervention arms Blinding: Patients, investigators collecting clinical data, and endoscopic video assessors are blinded to treatment allocation. The dietitian and endoscopist performing FMT (or sham FMT) are unblinded
Intervention Arms:
Participants are assigned to one of four treatment arms:
FMT + Anti-inflammatory Diet (AID) +Advanced therapy FMT + Sham Diet+ Advanced therapy Sham FMT + AID+ Advanced therapy Sham FMT + Sham Diet+ Advanced therapy FMT is administered via colonoscopy at 0, 2, and 6 weeks, with responders receiving maintenance doses every 8 weeks until week 48
Participant Timeline and Assessments:
Baseline Assessments: Clinical, laboratory, and endoscopic evaluations, including serological tests, inflammatory markers, and microbiome profiling.
Follow-up Schedule: Visits occur at Week 0, Week 6, Week 10, and then every 8 weeks until Week 48.
Endoscopic Monitoring: Colonoscopy is performed at baseline, Week 10, and Week 48. Centralized endoscopic video scoring ensures consistency
Data Collection and Management:
Paper CRF's and Electronic Data: The paper based CRF's will be filled first and then data will be entered into a REDCap software.
Dietary Monitoring: Participants will use the IBD NutriCare mobile application for diet tracking.
Microbiome Analysis: Fecal samples are processed and analyzed at a designated microbiome research center.
Safety Monitoring and Compliance:
Adverse Event Reporting: All safety events, including potential serious adverse events (SAEs), are logged and monitored by the Data and Safety Monitoring Board (DSMB).
Protocol Deviations: Documented and assessed for impact on trial integrity. Training and Quality Control: Regular site training ensures adherence to the protocol, and periodic audits maintain data quality
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Fecal Microbiota Transplantation and Anti inflammatory diet and advanced therapy | Experimental | Other: Fecal Microbial Transplantation, Other: Anti-Inflammatory Diet, Other: Advanced Therapy1.Oral vancomycin 500 mg BD for 3 days before the first FMT 2.FMT via colonoscopy at 0, 2, and 6 weeks for induction of remission 3.FMT via colonoscopy every 8 weeks (week 10, 18, 26, 34, 42) for maintenance of remission, if the patient is responder to the induction therapy 4.If the patient is a non-responder or has treatment failure to induction, he/she will be withdrawn from the study. 5.Patients with secondary loss of response, in the maintenance phase, will be withdrawn from the study 6.AID for 48 weeks. 7.Advanced therapy as standard dose and schedule |
| Fecal Microbiota Transplantation and sham diet/standard dietary counselling and advanced therapy | Experimental | Other: Fecal Microbial Transplantation, Other: Sham Diet, Other: Advanced Therapy1.Oral vancomycin 500 mg BD for 3 days before the first FMT 2.FMT via colonoscopy at 0, 2, and 6 weeks for induction of remission 3.FMT via colonoscopy every 8 weeks (week 10, 18, 26, 34, 42) for maintenance of remission, if the patient is responder to the induction therapy 4.If the patient is a non-responder or has treatment failure to induction, he/she will be withdrawn from the study. 5.Patients with secondary loss of response, in the maintenance phase, will be withdrawn from the study 6. Sham AID/Standard dietary counseling for 48 weeks. 7. Advanced therapy as standard dose and schedule |
| Sham Transplantation and Anti inflammatory diet and advanced therapy | Experimental | Other: Anti-Inflammatory Diet, Other: Sham transplantation, Other: Advanced Therapy1.Oral placebo 1 BD for 3 days before first FMT 2.Sham FMT via colonoscopy (instillation of clean water) at 0, 2, and 6 weeks 3.Sham FMT via colonoscopy (instillation of clean water) every 8 weeks (week 10, 18, 26, 34, 42) for maintenance of remission, if the patient is responder to the induction therapy 4.If the patient is a non-responder or has treatment failure to induction therapy, he/she will be withdrawn from the study. 5.Patients with secondary loss of response, in the maintenance phase, will be withdrawn from the study 6. AID for 48 weeks. 7. Advanced therapy as standard dose and schedule. |
| Sham transplantation and Sham Diet and advanced therapy | Sham comparator | Other: Sham transplantation, Other: Sham Diet, Other: Advanced Therapy1.Oral placebo 1 BD for 3 days before first FMT 2. Sham FMT via colonoscopy (instillation of clean water) at 0, 2, and 6 weeks 3. Sham FMT via colonoscopy (instillation of clean water) every 8 weeks (week 10, 18, 26, 34, 42) for maintenance of remission, if the patient is responder to the induction therapy 4. If the patient is a non-responder or has treatment failure to induction therapy, he/she will be withdrawn from the study. 5. Patients with secondary loss of response, in the maintenance phase, will be withdrawn from the study 6. Sham AID/Standard dietary counseling for 48 weeks 7. Advanced therapy as standard dose and schedule |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adult (age 18 to 75 years) patients
- Patients with active UC (defined as mMS equal or greater than 3 with rectal bleed score equal or greater than 1 and Endoscopic Mayo score equal or greater than 2 documented within 3 months of randomization or mild symptoms with high inflammatory burden or poor prognostic features).
- Any disease extent E1, E2 or E3. Patients with Proctitis will be limited to 25 percent of the entire pool of patients.
- Patients with an inadequate response, loss of response, or intolerance to conventional therapies example, aminosalicylates, corticosteroids, immunosuppressants or advanced therapies including but not limited to anti TNF alpha agents, anti-integrins, anti IL 12 or IL 23 agents, anti IL 23 agents, JAK inhibitors, or S1P receptor modulators. The last administration of any such treatment must have occurred at least five half-lives prior to randomization.
- Confirmed diagnosis of UC. The diagnosis must be confirmed by endoscopic and histologic evidence and corroborated by a histopathology report
Key exclusion criteria (10 listed)
- Hospitalization of exacerbation of UC requiring intravenous corticosteroids
- Patients already on biologics (anti-tumor necrosis factor inhibitors) or small molecules (tofacitinib) for equal or more than 2 weeks.
- Clinical signs of fulminant colitis or toxic megacolon
- Positive assay or stool culture for pathogens (ova and parasite examination, bacteria) or positive test for Clostridioides difficile toxin or CMV (histology or IHC and or tissue PCR) at screening. (The patients with positive assay will be treated appropriately and tests will be repeated. Those with negative assay and persistent activity will be included in the study.)
- Active or inadequately treated infections, including Mycobacterium tuberculosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fecal Microbial TransplantationThis will involve colonoscopic instillation of fecal transplant | Other | Fecal Microbiota Transplantation and Anti inflammatory diet and advanced therapy, Fecal Microbiota Transplantation and sham diet/standard dietary counselling and advanced therapy |
| Anti-Inflammatory DietThe modified diet plan will be given to each study participant | Other | Fecal Microbiota Transplantation and Anti inflammatory diet and advanced therapy, Sham Transplantation and Anti inflammatory diet and advanced therapy |
| Sham transplantationSham FMT will involve saline infusion via colonoscopy | Other | Sham Transplantation and Anti inflammatory diet and advanced therapy, Sham transplantation and Sham Diet and advanced therapy |
| Sham DietDietary counselling alone | Other | Fecal Microbiota Transplantation and sham diet/standard dietary counselling and advanced therapy, Sham transplantation and Sham Diet and advanced therapy |
| Advanced TherapyAdvanced therapy as standard dose and schedule | Other | Fecal Microbiota Transplantation and Anti inflammatory diet and advanced therapy, Fecal Microbiota Transplantation and sham diet/standard dietary counselling and advanced therapy, Sham Transplantation and Anti inflammatory diet and advanced therapy, Sham transplantation and Sham Diet and advanced therapy |
Primary outcome
Proportion of Patients Achieving Clinical Remission and Endoscopic Response at 10 weeks
Time frame: 10 weeks
Proportion of patients having- 1. Clinical remission which is defined as the Modified Mayo Score (mMS) < 2 \ mMS- Full Title: Modified Mayo Score Range: 0 to 12 Higher Scores = Worse Outcome (A score of 0 represents no disease activity, and a score of 12 represents the most severe disease activity.) 2. Endoscopic response which is defined as Mayo Endoscopic Score (MES) by 1 point MES- Full Title: Mayo Endoscopic Score Range: 0 to 4 Higher Scores = Worse Outcome (A score of 0 represents normal endoscopic findings, and a score of 4 represents severe mucosal damage.
Proportion of patients having clinical remission and endoscopic remission at week 48
Time frame: 48 weeks
Proportion of patients having- 1. Clinical remission which is defined as the Modified Mayo Score (mMS) < 2 mMS- Full Title: Modified Mayo Score Range: 0 to 12 Higher Scores = Worse Outcome (A score of 0 represents no disease activity, and a score of 12 represents the most severe disease activity.) 2. Endoscopic response which is defined as Mayo Endoscopic Score (MES) by 1 point MES- Full Title: Mayo Endoscopic Score Range: 0 to 4 Higher Scores = Worse Outcome (A score of 0 represents normal endoscopic findings, and a score of 4 represents severe mucosal damage.
24 secondary outcomes
Proportion of patients having clinical response at week 10
Time frame: 10 weeks
Proportion of patients having clinical remission at week 10
Time frame: 10 weeks
Proportion of Patients achieving Symptomatic Response at Week 10
Time frame: 10 weeks
Proportion of Patients achieving Symptomatic Remission at week 10
Time frame: 10 weeks
Proportion of Patients Achieving Endoscopic Response at Week 10
Time frame: 10 weeks
Proportion of Patients Achieving Endoscopic Remission at Week 10
Time frame: 10 weeks
Proportion of Patients Achieving Histologic Remission at Week 10
Time frame: 10 weeks
Proportion of Patients Achieving Biomarker Remission at Week 10
Time frame: 10 weeks
Proportion of Patients Experiencing Adverse Events at Week 10
Time frame: 10 weeks
Fecal Microbiome and Metabolite Signature at Week 10
Time frame: 10 weeks
Dynamics of microbiome engraftment at week 10
Time frame: 10 weeks
Proportion of patients having clinical response at week 48
Time frame: 48 weeks
Proportion of patients having clinical remission at week 48
Time frame: 48 weeks
Proportion of Patients Achieving Symptomatic Response at Week 48
Time frame: 48 weeks
Proportion of Patients achieving Symptomatic Remission at Week 48
Time frame: 48 weeks
Proportion of Patients achieving Endoscopic Response at Week 48
Time frame: 48 weeks
Proportion of Patients achieving Endoscopic Remission at Week 48
Time frame: 48 weeks
Proportion of Patients achieving Histologic Remission at Week 48
Time frame: 48 weeks
Proportion of Patients Achieving Biomarker Remission at Week 48
Time frame: 48 weeks
Fecal Microbiome and Metabolite Signature at Week 48
Time frame: 48 weeks
Dynamics of microbiome engraftment at week 48
Time frame: 48 weeks
Proportion of Patients Experiencing Adverse Events at Week 48
Time frame: 48 weeks
Proportion of patients having adverse events at week 6
Time frame: 6 weeks
Proportion of patients having adverse events at week 26
Time frame: 26 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Prof Vineet Ahuja, DM Gastroenterology principal investigator
Department of Gastroenterology, AIIMS, New Delhi
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fecal Microbial Transplantation, Anti-Inflammatory Diet and Advanced Therapy in people with Ulcerative Colitis, run by All India Institute of Medical Sciences at 6 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Prof Vineet Ahuja, DM Gastroenterology (+91-9810707170, vineet.aiims@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patients Achieving Clinical Remission and Endoscopic Response at 10 weeks (time frame: 10 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.