Crohn DiseaseALTER-CDNCT06890650
A Study to Evaluate the Effect of Fecal Transplant and Dietary Changes on Disease Activity in Patients With Newly Diagnosed Active Crohn Disease
A study testing Fecal Microbial Transplantation and Crohns disease exclusion diet in people with Crohn Disease, run by All India Institute of Medical Sciences at 6 sites in India.
Trial summary
Dysbiosis can be rectified by several methods: antibiotics, prebiotics, probiotics, dietary modulation, and fecal microbiota transplantation. There has been limited success with the isolated use of antibiotics and pre/probiotics in the treatment of IBD. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Crohn Disease
- What is being tested?
- Fecal Microbial Transplantation and Crohns disease exclusion diet
- 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
- 168 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
- Patients with treatment-naive Crohns disease accessible with ileocolonoscopy
- Symptom onset of less than 12 months
- Mild to moderate disease activity with endoscopically active disease
- CDAI of greater than 150 and less than 450
- SES-CD of or equal to or greater than 6 (or equal to or greater than 4 if isolated ileal disease)
- Aged between 18-75 years
Who cannot join
- Patients with severe disease (CDAI greater than 450, SES-CD greater than 16) or requiring hospitalization
- Patients who have been received on corticosteroids, immunosuppressants (azathioprine/ 6- mercaptoprine/methotrexate) for greater than 2 weeks
- Biologicals or small molecule exposure
- Stricturing (non-passable stricture), fistulising phenotype or perianal fistula/abscess
- L4 disease
- Pregnant or lactating women
Show all 12Show fewer
- Previous surgery for CD
- Declining consent
- Not willing for FMT/Dietary advise
- Patients with current or recent history of clinically severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac, or neurological disease.
- Positive assay or stool culture for pathogens (ova and parasite examination, bacteria) or positive test for Clostridioides difficile toxin at screening#
- Patients infected with human immunodeficiency virus (HIV) # 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.
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 Gasteroentrology, +91-8872813399, docvishalsharma@gmail.com
Dr Vishal Sharma, DM Gastroenterology
- Not yet recruiting
Department of Gastroenterology, Lisie Hospital
Kochi, Kerala
Dr Mathew Philip, DM Gasteroentrology, +91-9846045469, drmathewphilip@gmail.com
Dr Kiran Josy, DM Gastroentrology, +91-9745243939, drkiranjosy@gmail.com
- Not yet recruiting
Department of Gastroenterology, Dayanand Medical College
Ludhiana, Punjab
Prof Ajit Sood, DM Gasteroentrology, +91-9815400718, ajitsood10@gmail.com
Dr Arshdeep Singh, DM Gastroentrology, +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 Gasteroentrology, +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
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, Banaras Hindu University
Varanasi, Uttar Pradesh
Dr Devesh Prakash Yadav, DM Gasteroentrology, +91-8130856563, devesh.thedoc@gmail.com
Dr Devesh Prakash Yadav, DM Gastroenterology
About this study
Official title: Efficacy of Microbiome Manipulation Strategies (fecAL Microbial Transplantation OR CDED OR Both) in Combination Standard Medical Therapy for Induction and Maintenance of Remission in Mild to Moderate tReatment naÃive Active Crohns Disease (ALTER-CD): a Multicentre Double-blind Factorial Randomized Controlled Trial
Dysbiosis can be rectified by several methods: antibiotics, prebiotics, probiotics, dietary modulation, and fecal microbiota transplantation. There has been limited success with the isolated use of antibiotics and pre/probiotics in the treatment of IBD. Among the measures of dietary manipulation, the use of exclusive enteral nutrition (EEN) has shown superior, or at least equivalent, efficacy compared with steroids in pediatric CD. Although the results in adults are not as encouraging, recent cohort studies in patients with complicated CD have shown good success rates. Definite exclusion diets that exclude pro-inflammatory dietary constituents have also been tested with good clinical efficacy in patients with CD, who even failed treatment with anti-TNF agents. Various dietary approaches, inclusive of exclusive enteral nutrition, partial enteral nutrition, and Crohn's disease exclusion diet have been reported to be of benefit and are associated with changes in gut microbiome. Fecal microbiota transplantation (FMT) defined as the infusion of fecal suspension from a healthy individual into the gastrointestinal tract of an individual with GI disease carries a diverse population of microbiota and their metabolites and has been tested with varying efficacy in IBD. In general, FMT has shown good success rates in randomized control trials in patients with UC who failed conventional agents. Although limited small RCTs exist in CD, cohort studies have also shown good success rates. Therefore, the use of FMT in addition to standard medical therapy, is a concept that has not been previously explored and forms the basis for the present study. Therefore, a well-powered RCT is required to resolve the role of FMT in CD. In this study, patients will be recruited in four arms. Group A includes FMT+CDED+SMT, in Group B FMT+SMT+SHAM DIET, in Group C Sham FMT+CDED+SMT, in Group D Sham FMT+ Sham Diet+ SMT given. 168 patients will be recruited across 6 centers for around 3 years. Follow-up of the patient will be done at 0,2,6 and 10 weeks and 8 weekly up to 48 weeks.
Read the detailed description
This study is a multi-center, double-blind, factorial randomized controlled trial designed to evaluate the efficacy of microbiome manipulation strategies using fecal microbiota transplantation (FMT), Crohn's Disease Exclusion Diet (CDED), or their combination in treatment-naïve patients with mild to moderate active Crohn's Disease (CD).
Study Setting
The trial is conducted at six FMT centers across India, with one additional center dedicated to microbiome analysis:
AIIMS, New Delhi, India Dayanand Medical College, Ludhiana, India PGIMER, Chandigarh, India Lisie Hospital, Kochi, India IMS, BHU, Varanasi, India Sion Hospital, Mumbai, India IIIT-Delhi, India(for microbiome analysis)
Intervention Details:
Fecal Microbiota Transplantation (FMT)- Patients receive a 3-day course of oral vancomycin (500 mg BD) before the first FMT.
Freshly prepared 50 g stool is used for each FMT, and the transplant is administered within 4 hours of preparation.
FMT is delivered via colonoscopy at weeks 0, 2, and 6, followed by 8-weekly maintenance sessions for responders at weeks 10, 18, 26, 34, 42.
Multiple donors (n≥2) are used to ensure microbiome diversity. The first FMT session is instilled in the right colon/terminal ileum post bowel preparation, whereas maintenance sessions involve left-colon infusion without bowel preparation.
Crohn's Disease Exclusion Diet (CDED)- Patients assigned to CDED follow a phased dietary protocol designed to limit exposure to pro-inflammatory dietary components and enhance gut microbiome stability.
CDED consists of an induction and maintenance phase, with structured dietary charts and counseling provided by a dietitian.
Compliance is monitored via telephonic interviews and a dedicated diet tracking app (IBD NutriCare).
Sham Interventions- Sham FMT: Patients receive sterile water or saline infusions via colonoscopy at the same time points as FMT.
Sham Diet: Patients receive general dietary advice but do not follow the CDED protocol.
Randomization and Blinding- Central randomization is conducted using a secure web-based system (REDCap), utilizing stratified randomization based on disease extent.
The study follows a double-blind approach:
Blinded: Patients, clinical assessors, and endoscopic scorers. Unblinded: Endoscopists administering FMT/sham FMT and dietitians providing dietary counseling.
Oral vancomycin and placebo capsules are identically packed to maintain blinding.
Data Collection and Assessments- Baseline Assessments (Week 0) Clinical Assessment: Crohn's Disease Activity Index (CDAI), symptom scoring, and dietary adherence evaluation.
Laboratory Tests: Hemogram, renal/liver function, CRP, ESR, fecal calprotectin, and microbiome profiling.
Endoscopy: SES-CD scoring with high-definition endoscopic video recording. Histology: Biopsy samples are analyzed using Distribution Chronicity and Activity (DCA) scoring.
Follow-up Assessments- Clinical assessments at weeks 0, 2, 4, 6, 10, and every 8 weeks thereafter. Endoscopic assessments at baseline, week 10, and week 48, with central reading of all videos.
Fecal microbiome analysis at baseline, week 10, and week 48. Safety and Monitoring- Adverse Events (AEs) graded per CTCAE criteria (Grades 1-5). Serious Adverse Events (SAEs) include hospitalization, life-threatening conditions, or death.
DSMB reviews interim safety data at week 10 and 24. Emergency unblinding is permitted for critical medical decisions. Data Management- Data is collected using REDCap, with role-based access controls. Endoscopic images and videos are securely stored for centralized analysis. Microbiome sequencing data is processed at IIIT-Delhi. Statistical Considerations- Sample size calculation: 168 patients (42 per arm, 90% power).
Analysis Plan:
Intention-to-treat (ITT) and per-protocol (PP) analyses. Longitudinal mixed-effects modeling for microbiome shift
- Conditions
- Crohn Disease
- Being tested
- Fecal Microbial Transplantation, Sham transplantation, Crohns disease exclusion diet, Sham diet
- Keywords
- Randomized controlled trial, factorial design, Fecal microbiota transplantation, Crohn disease, Crohn disease exclusion diet
- Medical subject headings
- Crohn Disease
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
Sham transplantationOther
Sham FMT will involve saline infusion via colonoscopy
Crohns disease exclusion dietOther
The modified diet plan will be given to each study participant
Sham dietOther
Dietary counselling alone
| Study group | Role | What they receive |
|---|---|---|
| Fecal Microbiota Transplantation(FMT) with Crohns disease exclusion diet(CDED) | Experimental | 1. Oral vancomycin 500 mg BD for 3 days before first FMT 2. FMT via colonoscopy at 0, 2 and 6 weeks followed by (if treatment responder) 8 weekly during maintenance between 10 to 48 weeks Receives: Other: Fecal Microbial Transplantation; Other: Crohns disease exclusion diet |
| Fecal microbiota transplantation(FMT) and sham diet | Experimental | 1. Oral vancomycin 500 mg BD for 3 days before first FMT 2. FMT via colonoscopy at 0, 2 and 6 weeks followed by (if treatment responder) 10 weeks and then 8 weekly during maintenance between 10 to 42 weeks 3. Diet counselling for 48 weeks Receives: Other: Fecal Microbial Transplantation; Other: Sham diet |
| Crohns Disease Exclusion Diet(CDED) and sham transplantation | Experimental | 1. Oral placebo 1 BD for 3 days before first FMT 2. Sham transplantation (clean water) via colonoscopy at 0, 2 and 6 weeks followed by (if treatment responder) 8 weekly during maintenance between 10 to 48 weeks 3.Crohns Disease Exclusion Diet for 48 weeks Receives: Other: Sham transplantation; Other: Crohns disease exclusion diet |
| Sham transplantation with Sham diet | Sham comparator | 1.Oral placebo 1 BD for 3 days before first sham transplantation 2. Sham colonoscopy with instillation of saline at 0, 2, and 6 weeks followed by (if treatment responder) - 8-weekly during maintenance between 10 to 48 weeks Receives: Other: Sham transplantation; Other: Sham diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with clinical remission and endoscopic response at week 10
Proportion of patients with clinical remission (defined as CDAI less than 150) and endoscopic response( defined decline in SES-CD by gretaer than 50%).
Measured: 10 weeks
Proportion of patients with clinical remission and endoscopic remission at week 48
Proportion of patients with clinical remission (defined as Crohn's disease activity index less than 150) and endoscopic remission (defined as Simple Endoscopic Score for Crohn's disease patients less than 3)
Measured: 48 weeks
Secondary outcomes (16)
Proportion of patients with clinical response at Week 10
Proportion of patients with clinical response is defined as either CDAI decrease from baseline of at least 70 points or CDAI less than 150
Measured: 10 weeks
Proportion of patients with PRO2 Remission at Week 10
Proportion of patients with PRO2 Remission which is defined as Abdominal pain subscore of not more than 1 (on a scale of 0-3) and liquid or very soft stool (Bristol stool scale type 6 or 7) frequency subscore of not more than 3 calculated as a mean of 7 day count
Measured: 10 weeks
Proportion of patients with endoscopic response at Week 10
Proportion of patients with endoscopic response which is defined as 50% reduction from baseline on SES-CD
Measured: 10 weeks
Fecal microbiome and metabolite signature between responders and non-responders 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
Proportion of patients with biomarker remission at Week 10
Proportion of patients with biomarker remission which is defined as fecal calprotectin ≤150 mcg/g
Measured: 10 weeks
Proportion of patients with adverse events at Week 10
Proportion of Patients Experiencing Adverse Events (will be assessed according to common criteria for adverse events (CTCEA))
Measured: 10 weeks
Proportion of patients with clinical response at Week 48
Proportion of patients with clinical response is defined as either CDAI decrease from baseline of at least 70 points or CDAI less than 150
Measured: 48 weeks
Proportion of patients with PRO2 remission at Week 48
Proportion of patients with PRO2 remission is defined as Abdominal pain subscore of not more than 1 (on a scale of 0-3) and liquid or very soft stool (Bristol stool scale type 6 or 7) frequency subscore of not more than 3 calculated as a mean of 7 day count
Measured: 48 weeks
Proportion of patients with endoscopic response at Week 48
Proportion of patients with endoscopic response defined as 50% reduction from baseline on SES-CD
Measured: 48 weeks
Proportion of patients with Endoscopic remission at Week 48 weeks
Proportion of patients with Endoscopic remission defined as a SES-CD score of 2 or less
Measured: 48 weeks
Proportion of patients with corticosteroid-free clinical remission at Week 48
Proportion of patients with corticosteroid-free clinical remission is defined as the CDAI<150 with no exposure to steroids over the previous 8 weeks
Measured: 48 weeks
Fecal microbiome and metabolite signature between responders and non-responders 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
Proportion of patients with biomarker remission at Week 48
Proportion of patients with biomarker remission which is defined as fecal calprotectin ≤150 mcg/g
Measured: 48 weeks
Proportion of patients with adverse event at Week 48
Proportion of Patients Experiencing Adverse Events (will be assessed according to common criteria for adverse events (CTCEA))
Measured: 48 weeks
Proportion of patients with adverse event at Week 6
Proportion of Patients Experiencing Adverse Events (will be assessed according to common criteria for adverse events (CTCEA))
Measured: 6 weeks
Proportion of Patients Experiencing Adverse Events at Week 26
Proportion of Patients Experiencing Adverse Events (will be assessed according to common criteria for adverse events (CTCEA))
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 posted24 Mar 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 Crohn DiseaseStudies 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
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Post Graduate Institute of Medical Education and Research, Chandigarh, Dayanand Medical College and Hospital, Institute of Medical Sciences of the Banaras Hindu University, India, Lokmanya Tilak Municipal Medical College and Hospital, Lisie Hospital, Indraprastha Institute of Information Technology Delhi, Indian Council of Medical Research
- 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
- NCT06890650
- Sponsor's protocol ID
- AIIMSA2989/03.01.2025
- Other IDs
- EMDR/CARE/12/2023-0000572
- Acronym
- ALTER-CD
- Status last verified
- Apr 2025
- First submitted
- 3 Mar 2025
- Last updated
- 4 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 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Microbiome Manipulation Strategies (fecAL Microbial Transplantation OR CDED OR Both) in Combination Standard Medical Therapy for Induction and Maintenance of Remission in Mild to Moderate tReatment naÃive Active Crohns Disease (ALTER-CD): a Multicentre Double-blind Factorial Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06890650
- Acronym / sponsor ID
- ALTER-CD / AIIMSA2989/03.01.2025
- Conditions
- Crohn Disease
- Keywords
- Randomized controlled trial, factorial design, Fecal microbiota transplantation, Crohn disease, Crohn disease exclusion diet
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- All India Institute of Medical SciencesUniversity, hospital or other
- Collaborators
- Post Graduate Institute of Medical Education and Research, Chandigarh, Dayanand Medical College and Hospital, Institute of Medical Sciences of the Banaras Hindu University, India, Lokmanya Tilak Municipal Medical College and Hospital, Lisie Hospital, Indraprastha Institute of Information Technology Delhi, Indian Council of Medical Research
- Study start
- 15 Mar 2025 (actual)
- Primary completion
- 15 Mar 2027 (estimated)
- Study completion
- 15 Mar 2028 (estimated)
- First posted
- 24 Mar 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.
Dysbiosis can be rectified by several methods: antibiotics, prebiotics, probiotics, dietary modulation, and fecal microbiota transplantation. There has been limited success with the isolated use of antibiotics and pre/probiotics in the treatment of IBD. Among the measures of dietary manipulation, the use of exclusive enteral nutrition (EEN) has shown superior, or at least equivalent, efficacy compared with steroids in pediatric CD. Although the results in adults are not as encouraging, recent cohort studies in patients with complicated CD have shown good success rates. Definite exclusion diets that exclude pro-inflammatory dietary constituents have also been tested with good clinical efficacy in patients with CD, who even failed treatment with anti-TNF agents. Various dietary approaches, inclusive of exclusive enteral nutrition, partial enteral nutrition, and Crohn's disease exclusion diet have been reported to be of benefit and are associated with changes in gut microbiome. Fecal microbiota transplantation (FMT) defined as the infusion of fecal suspension from a healthy individual into the gastrointestinal tract of an individual with GI disease carries a diverse population of microbiota and their metabolites and has been tested with varying efficacy in IBD. In general, FMT has shown good success rates in randomized control trials in patients with UC who failed conventional agents. Although limited small RCTs exist in CD, cohort studies have also shown good success rates. Therefore, the use of FMT in addition to standard medical therapy, is a concept that has not been previously explored and forms the basis for the present study. Therefore, a well-powered RCT is required to resolve the role of FMT in CD. In this study, patients will be recruited in four arms. Group A includes FMT+CDED+SMT, in Group B FMT+SMT+SHAM DIET, in Group C Sham FMT+CDED+SMT, in Group D Sham FMT+ Sham Diet+ SMT given. 168 patients will be recruited across 6 centers for around 3 years. Follow-up of the patient will be done at 0,2,6 and 10 weeks and 8 weekly up to 48 weeks.
Detailed description
This study is a multi-center, double-blind, factorial randomized controlled trial designed to evaluate the efficacy of microbiome manipulation strategies using fecal microbiota transplantation (FMT), Crohn's Disease Exclusion Diet (CDED), or their combination in treatment-naïve patients with mild to moderate active Crohn's Disease (CD).
Study Setting
The trial is conducted at six FMT centers across India, with one additional center dedicated to microbiome analysis:
AIIMS, New Delhi, India Dayanand Medical College, Ludhiana, India PGIMER, Chandigarh, India Lisie Hospital, Kochi, India IMS, BHU, Varanasi, India Sion Hospital, Mumbai, India IIIT-Delhi, India(for microbiome analysis)
Intervention Details:
Fecal Microbiota Transplantation (FMT)- Patients receive a 3-day course of oral vancomycin (500 mg BD) before the first FMT.
Freshly prepared 50 g stool is used for each FMT, and the transplant is administered within 4 hours of preparation.
FMT is delivered via colonoscopy at weeks 0, 2, and 6, followed by 8-weekly maintenance sessions for responders at weeks 10, 18, 26, 34, 42.
Multiple donors (n≥2) are used to ensure microbiome diversity. The first FMT session is instilled in the right colon/terminal ileum post bowel preparation, whereas maintenance sessions involve left-colon infusion without bowel preparation.
Crohn's Disease Exclusion Diet (CDED)- Patients assigned to CDED follow a phased dietary protocol designed to limit exposure to pro-inflammatory dietary components and enhance gut microbiome stability.
CDED consists of an induction and maintenance phase, with structured dietary charts and counseling provided by a dietitian.
Compliance is monitored via telephonic interviews and a dedicated diet tracking app (IBD NutriCare).
Sham Interventions- Sham FMT: Patients receive sterile water or saline infusions via colonoscopy at the same time points as FMT.
Sham Diet: Patients receive general dietary advice but do not follow the CDED protocol.
Randomization and Blinding- Central randomization is conducted using a secure web-based system (REDCap), utilizing stratified randomization based on disease extent.
The study follows a double-blind approach:
Blinded: Patients, clinical assessors, and endoscopic scorers. Unblinded: Endoscopists administering FMT/sham FMT and dietitians providing dietary counseling.
Oral vancomycin and placebo capsules are identically packed to maintain blinding.
Data Collection and Assessments- Baseline Assessments (Week 0) Clinical Assessment: Crohn's Disease Activity Index (CDAI), symptom scoring, and dietary adherence evaluation.
Laboratory Tests: Hemogram, renal/liver function, CRP, ESR, fecal calprotectin, and microbiome profiling.
Endoscopy: SES-CD scoring with high-definition endoscopic video recording. Histology: Biopsy samples are analyzed using Distribution Chronicity and Activity (DCA) scoring.
Follow-up Assessments- Clinical assessments at weeks 0, 2, 4, 6, 10, and every 8 weeks thereafter. Endoscopic assessments at baseline, week 10, and week 48, with central reading of all videos.
Fecal microbiome analysis at baseline, week 10, and week 48. Safety and Monitoring- Adverse Events (AEs) graded per CTCAE criteria (Grades 1-5). Serious Adverse Events (SAEs) include hospitalization, life-threatening conditions, or death.
DSMB reviews interim safety data at week 10 and 24. Emergency unblinding is permitted for critical medical decisions. Data Management- Data is collected using REDCap, with role-based access controls. Endoscopic images and videos are securely stored for centralized analysis. Microbiome sequencing data is processed at IIIT-Delhi. Statistical Considerations- Sample size calculation: 168 patients (42 per arm, 90% power).
Analysis Plan:
Intention-to-treat (ITT) and per-protocol (PP) analyses. Longitudinal mixed-effects modeling for microbiome shift
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(FMT) with Crohns disease exclusion diet(CDED) | Experimental | Other: Fecal Microbial Transplantation, Other: Crohns disease exclusion diet1. Oral vancomycin 500 mg BD for 3 days before first FMT 2. FMT via colonoscopy at 0, 2 and 6 weeks followed by (if treatment responder) 8 weekly during maintenance between 10 to 48 weeks |
| Fecal microbiota transplantation(FMT) and sham diet | Experimental | Other: Fecal Microbial Transplantation, Other: Sham diet1. Oral vancomycin 500 mg BD for 3 days before first FMT 2. FMT via colonoscopy at 0, 2 and 6 weeks followed by (if treatment responder) 10 weeks and then 8 weekly during maintenance between 10 to 42 weeks 3. Diet counselling for 48 weeks |
| Crohns Disease Exclusion Diet(CDED) and sham transplantation | Experimental | Other: Sham transplantation, Other: Crohns disease exclusion diet1. Oral placebo 1 BD for 3 days before first FMT 2. Sham transplantation (clean water) via colonoscopy at 0, 2 and 6 weeks followed by (if treatment responder) 8 weekly during maintenance between 10 to 48 weeks 3.Crohns Disease Exclusion Diet for 48 weeks |
| Sham transplantation with Sham diet | Sham comparator | Other: Sham transplantation, Other: Sham diet1.Oral placebo 1 BD for 3 days before first sham transplantation 2. Sham colonoscopy with instillation of saline at 0, 2, and 6 weeks followed by (if treatment responder) - 8-weekly during maintenance between 10 to 48 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with treatment-naive Crohns disease accessible with ileocolonoscopy
- Symptom onset of less than 12 months
- Mild to moderate disease activity with endoscopically active disease
- Aged between 18-75 years
Key exclusion criteria (12 listed)
- Patients with severe disease (CDAI greater than 450, SES-CD greater than 16) or requiring hospitalization
- Patients who have been received on corticosteroids, immunosuppressants (azathioprine/ 6- mercaptoprine/methotrexate) for greater than 2 weeks
- Biologicals or small molecule exposure
- Stricturing (non-passable stricture), fistulising phenotype or perianal fistula/abscess
- L4 disease
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(FMT) with Crohns disease exclusion diet(CDED), Fecal microbiota transplantation(FMT) and sham diet |
| Sham transplantationSham FMT will involve saline infusion via colonoscopy | Other | Crohns Disease Exclusion Diet(CDED) and sham transplantation, Sham transplantation with Sham diet |
| Crohns disease exclusion dietThe modified diet plan will be given to each study participant | Other | Crohns Disease Exclusion Diet(CDED) and sham transplantation, Fecal Microbiota Transplantation(FMT) with Crohns disease exclusion diet(CDED) |
| Sham dietDietary counselling alone | Other | Fecal microbiota transplantation(FMT) and sham diet, Sham transplantation with Sham diet |
Primary outcome
Proportion of patients with clinical remission and endoscopic response at week 10
Time frame: 10 weeks
Proportion of patients with clinical remission (defined as CDAI less than 150) and endoscopic response( defined decline in SES-CD by gretaer than 50%).
Proportion of patients with clinical remission and endoscopic remission at week 48
Time frame: 48 weeks
Proportion of patients with clinical remission (defined as Crohn's disease activity index less than 150) and endoscopic remission (defined as Simple Endoscopic Score for Crohn's disease patients less than 3)
16 secondary outcomes
Proportion of patients with clinical response at Week 10
Time frame: 10 weeks
Proportion of patients with PRO2 Remission at Week 10
Time frame: 10 weeks
Proportion of patients with endoscopic response at Week 10
Time frame: 10 weeks
Fecal microbiome and metabolite signature between responders and non-responders at week 10
Time frame: 10 weeks
Proportion of patients with biomarker remission at Week 10
Time frame: 10 weeks
Proportion of patients with adverse events at Week 10
Time frame: 10 weeks
Proportion of patients with clinical response at Week 48
Time frame: 48 weeks
Proportion of patients with PRO2 remission at Week 48
Time frame: 48 weeks
Proportion of patients with endoscopic response at Week 48
Time frame: 48 weeks
Proportion of patients with Endoscopic remission at Week 48 weeks
Time frame: 48 weeks
Proportion of patients with corticosteroid-free clinical remission at Week 48
Time frame: 48 weeks
Fecal microbiome and metabolite signature between responders and non-responders at Week 48
Time frame: 48 weeks
Proportion of patients with biomarker remission at Week 48
Time frame: 48 weeks
Proportion of patients with adverse event at Week 48
Time frame: 48 weeks
Proportion of patients with adverse event at Week 6
Time frame: 6 weeks
Proportion of Patients Experiencing 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 4 Apr 2025.
- Individual participant dataSharing planned: No
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Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
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 and Crohns disease exclusion diet in people with Crohn Disease, 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 6 inclusion and 12 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 4 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 with clinical remission and endoscopic response at week 10 (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 4 Apr 2025.