Active Ulcerative Colitis (UC)Phase 1NCT05786404
Study to Evaluate the Fecal Microbiota Transplantation (FMT) in the Treatment of Ulcerative Colitis
A Phase 1 study testing PRIM-DJ2727 - FROZEN and PRIM-DJ2727 - CAPSULES in people with Active Ulcerative Colitis (UC), run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The study is to evaluate the safety, feasibility, and preliminary efficacy of frozen FMT delivery via retention enema compared to lyophilized powder given in oral capsules as induction FMT in subjects with active UC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Active Ulcerative Colitis (UC)
- What is being tested?
- PRIM-DJ2727 - FROZEN and PRIM-DJ2727 - CAPSULES
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2023to 15 Dec 2027
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of active UC defined on clinical grounds (Partial Mayo score ≥ 3 with each subscore >1)
- Sexually active male and female subjects of childbearing potential must agree to use an effective method of birth control during the study.
- Female subjects of childbearing potential must have a negative urine Qualitative Human Chorionic Gonadotropin(HCG)pregnancy test at enrolment and on the Week 1, Day 1 of the Treatment prior to administration of study drug.
- Willing and able to sign an informed consent form and attend all study-related clinic visits, assessments, and follow-up phone calls.
- Subject has an attending physician who will provide the non-FMT care.
Who cannot join
- Subjects with sever UC (Mayo score of >7)
- Unable to take retention enema or multiple capsules orally.
- Females who are pregnant, breastfeeding, or planning to become pregnant during the study.
- Receipt of systemic non-topical antibiotics within 14 days of treatment day 1.
- Positive results for active HIV, Hepatitis B, or Hepatitis C infections.
- History of recurrent Clostridium difficile infection or FMT in the past 6-months.
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- History of other active gastrointestinal conditions such as irritable bowel syndrome, microscopic colitis, celiac disease, short gut syndrome, colostomy, colectomy, gastrointestinal fistulae or strictures, chronic parasitic infections, diverticulitis etc.
- Known history of bile acid diarrhea
- Compromised immune system (e.g. primary immune disorders or clinical immunosuppression due to a medical condition or medication e.g. taking oral prednisone >20 mg a day or prednisone-equivalent)
- History of active cancer and/or ongoing chemotherapy (superficial non-metastatic cancers and maintenance chemotherapy are permitted).
- History of use of an investigational drug within 90 days prior to the screening visit.
- History of significant uncontrolled systemic disease that in the opinion of the study investigator could interfere with study participation and/or objectives.
- Life expectancy of < 1 year.
- In the opinion of investigator, subject for any reason, should be excluded from the study.
- Absolute neutrophil count (ANC) < 500IU/mL
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Zhi-Dong Jiang, Dr.PH contact
United States1 site, 1 recruiting
- Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Herbert L DuPont, MD, 713-500-9366, herbert.l.dupont@uth.tmc.edu
Zhi-Dong Jiang, Dr.PH, 713 500 9371, zhi-dong.jiang@uth.tmc.edu
About this study
Official title: A Randomized, Open-label, Pilot Study to Evaluate the Fecal Microbiota Transplantation (FMT) in the Treatment of Ulcerative Colitis
The study is to evaluate the safety, feasibility, and preliminary efficacy of frozen FMT delivery via retention enema compared to lyophilized powder given in oral capsules as induction FMT in subjects with active UC. This study will also determine changes in microbiome (diversity and genera) and proportion of antibody-coated microbiota from baseline to after completion of FMT.
Read the detailed description
Studies have shown that microbiota disturbances occur in patients with ulcerative colitis (UC). This study will evaluate safety and preliminary efficacy of microbiota replacement treatment in active UC, and changes in microbiome (diversity and genera) and proportion of antibody-coated microbiota from baseline to after completion of FMT. Studies have shown that microbiota disturbances occur in patients with ulcerative colitis (UC). This study will evaluate safety and preliminary efficacy of microbiota replacement treatment in active UC, and changes in microbiome (diversity and genera) and proportion of antibody-coated microbiota from baseline to after completion of FMT.
- Conditions
- Active Ulcerative Colitis (UC)
- Being tested
- PRIM-DJ2727 - FROZEN, PRIM-DJ2727 - CAPSULES
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRIM-DJ2727 - FROZENDrug
Patients with active UC will receive induction dose of 100 grams of stool via frozen retention enema, Fecal Microbiota Transplantation (FMT) product manufactured as PRIM-DJ2727-FROZEN administered in clinic. This consists of microbiota suspension from well-screened donors. Twice filtered fecal microbiota product diluted in saline to 500 mL containing 100g of study drug will be administered as frozen enema induction dose
PRIM-DJ2727 - CAPSULESDrug
Patients with active UC will receive induction dose of 100 grams of stool in orally administered enteric-coated capsules Fecal Microbiota Transplantation (FMT) product manufactured as PRIM-DJ2727-CAPSULES.These capsules consists of microbiota from well-screened donors. The induction dose of enteric-coated capsules will be derived from 100 grams stool.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: PRIM-DJ2727 - FROZEN | Experimental | Not described Receives: Drug: PRIM-DJ2727 - FROZEN |
| Experimental: PRIM-DJ2727 - CAPSULES | Experimental | Not described Receives: Drug: PRIM-DJ2727 - CAPSULES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease severity as assessed by the Partial Mayo Score (PMS) for Ulcerative Colitis (UC)
This is a 3 item questionnaire and each is measured from 0-3, for a maximum score of 9 a higher number indicating worse outcome
Measured: week 5
Change in fecal microbiota diversity and genera as assessed by sequencing
Measured: Baseline,end of treatment (4 weeks after baseline)
Change in proportion of antibody-coated microbiota as assessed by the antibiotic susceptibility test
Measured: Baseline,end of treatment (4 weeks after baseline)
Safety as assessed by the adverse events
Adverse events include death, life-threatening adverse event, hospitalization ≥ 24 hours, prolongation of existing hospitalization, substantial disruption of the ability to conduct normal life functions, congenital abnormally/birth defect, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions or other important events that jeopardize the patient and may require medical or surgical intervention (e.g. allergic bronchospasm requiring intensive treatment)
Measured: 3 months after last dose
Safety as assessed by the adverse events
Adverse events include death, life-threatening adverse event, hospitalization ≥ 24 hours, prolongation of existing hospitalization, substantial disruption of the ability to conduct normal life functions, congenital abnormally/birth defect, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions or other important events that jeopardize the patient and may require medical or surgical intervention (e.g. allergic bronchospasm requiring intensive treatment)
Measured: 6 months after last dose
Secondary outcomes (4)
Change in quality of life as assessed by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ) score
This is a 10 item questionnaire and each is scored from 1(all of the time) to 7 (none of the time) for a maximum score of 70 a higher number indicating better quality of life
Measured: baseline, week 5, early termination(if applicable)
Change in anxiety and depression as assessed by the Hospital Anxiety and Depression Scale (HADS)
This is a fourteen-item questionnaire to assess anxiety and depression. Seven items are related to anxiety symptoms and seven to depressive symptoms. Each item is coded from 0 to 3. The scores for anxiety and depression can therefore vary from 0 to 21, a higher number indicating worse outcome
Measured: baseline, week 5, early termination(if applicable)
Change in fecal microbiota diversity and genera as assessed by sequencing
Measured: Baseline,end of treatment (4 weeks after baseline), 6 months
Change in proportion of antibody-coated microbiota as assessed by the gut microbiota taxonomy by sequencing
Measured: Baseline,end of treatment (4 weeks after baseline), 6 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start15 Dec 2023
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Active Ulcerative Colitis (UC)Studies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Dupont, The University of Texas Health Science Center, Houston
- Investigators
- Herbert L DuPont, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05786404
- Sponsor's protocol ID
- HSC-MS-23-0016
- Status last verified
- May 2024
- First submitted
- 13 Mar 2023
- Last updated
- 10 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Pilot Study to Evaluate the Fecal Microbiota Transplantation (FMT) in the Treatment of Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT05786404
- Acronym / sponsor ID
- HSC-MS-23-0016
- Conditions
- Active Ulcerative Colitis (UC)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 15 Dec 2027 (estimated)
- First posted
- 27 Mar 2023 (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.
The study is to evaluate the safety, feasibility, and preliminary efficacy of frozen FMT delivery via retention enema compared to lyophilized powder given in oral capsules as induction FMT in subjects with active UC. This study will also determine changes in microbiome (diversity and genera) and proportion of antibody-coated microbiota from baseline to after completion of FMT.
Detailed description
Studies have shown that microbiota disturbances occur in patients with ulcerative colitis (UC). This study will evaluate safety and preliminary efficacy of microbiota replacement treatment in active UC, and changes in microbiome (diversity and genera) and proportion of antibody-coated microbiota from baseline to after completion of FMT. Studies have shown that microbiota disturbances occur in patients with ulcerative colitis (UC). This study will evaluate safety and preliminary efficacy of microbiota replacement treatment in active UC, and changes in microbiome (diversity and genera) and proportion of antibody-coated microbiota from baseline to after completion of FMT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: PRIM-DJ2727 - FROZEN | Experimental | Drug: PRIM-DJ2727 - FROZEN |
| Experimental: PRIM-DJ2727 - CAPSULES | Experimental | Drug: PRIM-DJ2727 - CAPSULES |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of active UC defined on clinical grounds (Partial Mayo score ≥ 3 with each subscore >1)
- Sexually active male and female subjects of childbearing potential must agree to use an effective method of birth control during the study.
- Female subjects of childbearing potential must have a negative urine Qualitative Human Chorionic Gonadotropin(HCG)pregnancy test at enrolment and on the Week 1, Day 1 of the Treatment prior to administration of study drug.
- Willing and able to sign an informed consent form and attend all study-related clinic visits, assessments, and follow-up phone calls.
- Subject has an attending physician who will provide the non-FMT care.
Key exclusion criteria (15 listed)
- Subjects with sever UC (Mayo score of >7)
- Unable to take retention enema or multiple capsules orally.
- Females who are pregnant, breastfeeding, or planning to become pregnant during the study.
- Receipt of systemic non-topical antibiotics within 14 days of treatment day 1.
- Positive results for active HIV, Hepatitis B, or Hepatitis C infections.
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 |
|---|---|---|
| PRIM-DJ2727 - FROZENPatients with active UC will receive induction dose of 100 grams of stool via frozen retention enema, Fecal Microbiota Transplantation (FMT) product manufactured as PRIM-DJ2727-FROZEN administered in clinic. This consists of microbiota suspension from well-screened donors. Twice filtered fecal microbiota product diluted in saline to 500 mL containing 100g of study drug will be administered as frozen enema induction dose | Drug | Experimental: PRIM-DJ2727 - FROZEN |
| PRIM-DJ2727 - CAPSULESPatients with active UC will receive induction dose of 100 grams of stool in orally administered enteric-coated capsules Fecal Microbiota Transplantation (FMT) product manufactured as PRIM-DJ2727-CAPSULES.These capsules consists of microbiota from well-screened donors. The induction dose of enteric-coated capsules will be derived from 100 grams stool. | Drug | Experimental: PRIM-DJ2727 - CAPSULES |
Primary outcome
Disease severity as assessed by the Partial Mayo Score (PMS) for Ulcerative Colitis (UC)
Time frame: week 5
This is a 3 item questionnaire and each is measured from 0-3, for a maximum score of 9 a higher number indicating worse outcome
Change in fecal microbiota diversity and genera as assessed by sequencing
Time frame: Baseline,end of treatment (4 weeks after baseline)
Change in proportion of antibody-coated microbiota as assessed by the antibiotic susceptibility test
Time frame: Baseline,end of treatment (4 weeks after baseline)
Safety as assessed by the adverse events
Time frame: 3 months after last dose
Adverse events include death, life-threatening adverse event, hospitalization ≥ 24 hours, prolongation of existing hospitalization, substantial disruption of the ability to conduct normal life functions, congenital abnormally/birth defect, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions or other important events that jeopardize the patient and may require medical or surgical intervention (e.g. allergic bronchospasm requiring intensive treatment)
Safety as assessed by the adverse events
Time frame: 6 months after last dose
Adverse events include death, life-threatening adverse event, hospitalization ≥ 24 hours, prolongation of existing hospitalization, substantial disruption of the ability to conduct normal life functions, congenital abnormally/birth defect, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions or other important events that jeopardize the patient and may require medical or surgical intervention (e.g. allergic bronchospasm requiring intensive treatment)
4 secondary outcomes
Change in quality of life as assessed by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ) score
Time frame: baseline, week 5, early termination(if applicable)
Change in anxiety and depression as assessed by the Hospital Anxiety and Depression Scale (HADS)
Time frame: baseline, week 5, early termination(if applicable)
Change in fecal microbiota diversity and genera as assessed by sequencing
Time frame: Baseline,end of treatment (4 weeks after baseline), 6 months
Change in proportion of antibody-coated microbiota as assessed by the gut microbiota taxonomy by sequencing
Time frame: Baseline,end of treatment (4 weeks after baseline), 6 months follow up
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 10 May 2024.
- 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.
Zhi-Dong Jiang, Dr.PH contact
Herbert L DuPont, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PRIM-DJ2727 - FROZEN and PRIM-DJ2727 - CAPSULES in people with Active Ulcerative Colitis (UC), run by The University of Texas Health Science Center, Houston at 1 site in United States.
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 5 inclusion and 15 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 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Herbert L DuPont, MD (713 500 6687, herbert.l.dupont@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease severity as assessed by the Partial Mayo Score (PMS) for Ulcerative Colitis (UC) (time frame: week 5). The study lists 5 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 10 May 2024.