Adults With Ulcerative Colitis
Oral Fecal Microbiota Capsules to Prevent Ulcerative Colitis Relapse
This study is investigating the safety and efficacy of oral PRIM-DJ2727 fecal microbiota transplantation capsules, compared with placebo, for preventing renewed intestinal inflammation or relapse in adults whose ulcerative colitis is in remission.
Registry title: Evaluation the Safety and Efficacy of Lyophilized Fecal Microbiota Transplantation Administered Orally for Prevention of Relapse or Intestinal Inflammation in Adults With Ulcerative Colitis
1 recruiting U.S. site ↓Study at a glance
- Age
- 18 Years and older
- Treatment
- PRIM-DJ2727 or Placebos
- Design
- Randomized · Quadruple
- Central study contact
- Herbert DuPont, md713 500 6687herbert.l.dupont@uth.tmc.edu
- Sponsor
- The University of Texas Health Science Center, Houston
Research question
Among adults with ulcerative colitis in remission, how safe and effective are oral PRIM-DJ2727 capsules, given with standard care, at preventing relapse or renewed intestinal inflammation compared with placebo?
Participant snapshot
Who the study is looking for
- The study is looking for adults age 18 or older with ulcerative colitis.
- The study is looking for people who had active ulcerative colitis during the past 12 months, documented using standard clinical, endoscopic, or tissue-based criteria.
- The study is looking for people whose ulcerative colitis is currently in clinical remission, with a partial Mayo score of 2 or lower and no subscore above 1.
- The study is looking for people on stable maintenance therapy who have an attending physician to provide care unrelated to fecal microbiota transplantation.
- The listed study location is in Houston, Texas, and the registry marks that site as recruiting.
Participation overview
What participation may involve
Participants receive oral PRIM-DJ2727 or matching placebo and undergo clinical and patient-reported assessments; the study also analyzes changes in gut microbiota. What participation may involve: - Take PRIM-DJ2727 fecal microbiota capsules or matching placebo capsules by mouth. - Continue stable maintenance therapy and receive non-fecal-microbiota-transplant care from an attending physician. - Complete assessments of ulcerative colitis remission, health-related quality of life, anxiety, and depression. - Provide material for longitudinal analyses of gut microbiota taxonomy and metagenomics; the record does not specify the sample type or collection schedule. - Attend study clinic visits, complete assessments, and participate in follow-up phone calls.
Study interventions
What participants may receive or do
- PRIM-DJ2727: Participants assigned to this group receive oral fecal microbiota transplantation capsules containing freeze-dried microbiota combined from three screened donors.
- Placebos: Participants assigned to this group receive capsules that look like PRIM-DJ2727 but do not contain intestinal bacteria.
Study design
How the comparison works
This Phase 2 interventional study plans to enroll 58 participants in parallel groups receiving either PRIM-DJ2727 or matching placebo, alongside standard care. Participants are assigned randomly to one of the parallel study groups; the registry does not report the allocation ratio. The participant, care provider, investigator, and outcome assessor are masked to treatment assignment. The control group receives matching capsules without intestinal bacteria. A placebo is used, but the registry does not state each participant's probability of receiving it.
Reported activities
Procedures and tests
- Partial Mayo score assessment to evaluate clinical remission.
- Longitudinal analysis of gut microbiota taxonomy and metagenomics.
- Health-related quality-of-life assessment.
- Hospital Anxiety and Depression Scale questionnaire.
- For participants who could become pregnant, a urine qualitative human chorionic gonadotropin pregnancy test at enrollment and before study drug administration on Week 1, Day 1.
- Screening may involve confirming that there is no active human immunodeficiency virus, hepatitis B, or hepatitis C infection.
Eligibility highlights
Details that may affect whether you contact the study
These are selected highlights, not a complete eligibility check. Exact criteria remain in the full registry record below.
Common requirements
- Participants must be age 18 or older.
- Participants must have had active ulcerative colitis within the past 12 months, based on standard clinical, endoscopic, or histologic criteria.
- Ulcerative colitis must be in clinical remission, defined as a partial Mayo score of 2 or lower with every subscore 1 or lower, while the person is on stable maintenance therapy.
- Sexually active participants who could conceive or cause a pregnancy must agree to use effective birth control during the study.
- Participants who could become pregnant must have a negative urine pregnancy test at enrollment and again before study drug administration on Week 1, Day 1.
- Participants must be willing and able to give informed consent and attend all required clinic visits, assessments, and follow-up calls.
- Participants must have an attending physician who will provide care unrelated to fecal microbiota transplantation.
Possible reasons someone may not be able to join
- People who cannot swallow multiple capsules are excluded.
- People who are pregnant, breastfeeding, or planning pregnancy during the study are excluded.
- Receiving systemic, non-topical antibiotics within 14 days before treatment Day 1 is exclusionary.
- Active human immunodeficiency virus, hepatitis B, or hepatitis C infection is exclusionary.
- Recurrent Clostridium difficile infection or fecal microbiota transplantation within the past six months is exclusionary.
- Other active gastrointestinal conditions or specified structural gastrointestinal problems are exclusionary, including those listed by the registry.
- A compromised immune system is exclusionary; the registry gives oral prednisone above 20 mg daily, or an equivalent dose, as one example of medication-related immunosuppression.
- Active cancer or ongoing chemotherapy is generally exclusionary, although superficial non-metastatic cancers and maintenance chemotherapy are permitted.
- Use of an investigational drug within 90 days before screening is exclusionary.
Important unknowns
What the record does not make clear
- The record requires clinic visits, assessments, and follow-up calls but does not report their number or schedule.
- The outcomes mention 12 weeks of capsule administration and assessments at nine months, but the record does not clearly state each participant's total participation period.
- The study is randomized and includes a placebo group, but the allocation ratio is not reported.
- The record requires stable maintenance therapy and says the study treatment is combined with standard care, but it does not specify which ulcerative colitis medicines may continue or what changes are permitted.
- The record gives timing restrictions for systemic antibiotics and investigational drugs but does not provide a complete list of medication washout requirements.
- The record does not describe what treatment is available if ulcerative colitis symptoms return or worsen.
- Prior disease activity may be documented endoscopically, but the record does not state whether a new endoscopy is required for screening or follow-up.
- The record does not explain which study-related or routine-care costs are covered or billed to insurance.
- The record does not state whether participants are compensated.
- The record does not state whether transportation, parking, lodging, or other travel support is available.
- Follow-up phone calls are required, but the record does not state whether any clinic visits or assessments can be completed remotely.
- The record does not state whether PRIM-DJ2727 is available after study participation ends.
Before contacting the site
Questions for the study team
- What is the complete schedule of clinic visits, assessments, phone calls, and capsule dosing?
- What is the chance of receiving placebo, and when will treatment assignments be revealed?
- Which ulcerative colitis medicines must remain unchanged, and what happens if a treatment change becomes medically necessary?
- What happens if symptoms return or the partial Mayo score worsens during participation?
- Will participation require stool, blood, tissue, colonoscopy, or sigmoidoscopy samples, and how often?
- Which study-related costs are covered, and are compensation or travel support available?
- Are there side effects, infection risks, or donor-screening details that are not included in the registry record?
Before changing care
Questions for your gastroenterologist
- Is my ulcerative colitis stable enough that considering this study would be reasonable to discuss with the research team?
- Could any of my current medicines conflict with the study's stable-therapy requirement, antibiotic restriction, or immunosuppression exclusion?
- What approved maintenance-treatment alternatives should I understand before considering research participation?
- What risks of fecal microbiota transplantation are most relevant given my disease history, medications, and immune status?
- How should my attending gastroenterologist and the research team coordinate routine care if symptoms worsen or treatment changes are needed?
This plain-language digest is provided by the Aidy clinical trials API. It may omit details and is not medical advice or an eligibility decision. Review the full registry record and confirm details with the study team.
Source record
Full registry record
The sections below preserve the study information supplied through ClinicalTrials.gov, including complete descriptions, criteria, outcomes, and locations.
About this study
The purpose of the study is to evaluate the efficacy and safety of lyophilized PRIM-DJ2727 capsules given orally in subjects with ulcerative colitis at remission stage. This study will also include longitudinal analyses of recipient's gut microbiota taxonomy and metagenomics to determine potential associations with clinical outcomes in context of active FMT or placebo administration.
Study design and administration
- Organization
- The University of Texas Health Science Center, Houston
- Organization class
- Other
- Organization study ID
- HSC-MS-20-0316
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor class
- Other
- Enrollment type
- Estimated
- Allocation
- Randomized
- Intervention model
- Parallel
- Primary purpose
- Treatment
- Masking
- Quadruple
- Who is masked
- Participant, Care Provider, Investigator, Outcomes Assessor
- Standard age groups
- Adult, Older Adult
Study arms
Experimental
Patients with UC will receive FMT capsules
Patients with ulcerative colitis will receive fecal microbiota capsules from 3 healthy donors
Interventions: Drug: PRIM-DJ2727
Placebo Comparator
Patients with UC will receive placebo
Patients with ulcerative colitis will receive matching placebo capsules. Placebo capsule will be identical to PRIM-DJ2727 but will not contain intestinal bacteria.
Interventions: Drug: Placebos
Interventions
Drug
PRIM-DJ2727
Fecal Microbiota Transplantation (FMT) product manufactured as PRIM-DJ2727 capsules consists of lyophilized microbiota suspension from well-screened donors. Microbiota from three donors will be combined to make the product.
Drug
Placebos
Placebo capsule will be identical to PRIM-DJ2727 but will not contain intestinal bacteria.
Eligibility
18 Years and older
All
Not accepted
Inclusion criteria (7)
- Adult ≥18 years of ageRegistry-derived · unreviewed
- History of active UC in the past 12 months based on standard clinical, endoscopic, or histologic criteria.Registry-derived · unreviewed
- Remission of UC based on clinical grounds (partial Mayo score of ≤2 with each subscore ≤1), and on stable maintenance therapy.Registry-derived · unreviewed
- Sexually active male and female subjects of childbearing potential must agree to use an effective method of birth control during the study.Registry-derived · unreviewed
- Female subjects of childbearing potential must have a negative urine Qualitative HCG pregnancy test at enrolment and on the Week 1, Day 1 of the Treatment prior to administration of study drug.Registry-derived · unreviewed
- Willing and able to sign an informed consent form and attend all study-related clinic visits, assessments, and follow-up phone calls.Registry-derived · unreviewed
- Subject has an attending physician who will provide the non-FMT care.Registry-derived · unreviewed
Exclusion criteria (13)
- Unable to take multiple capsules orally.Registry-derived · unreviewed
- Females who are pregnant, breastfeeding, or planning to become pregnant during the study.Registry-derived · unreviewed
- Receipt of systemic non-topical antibiotics within 14 days of treatment day 1.Registry-derived · unreviewed
- Positive results for active HIV, Hepatitis B, or Hepatitis C infections.Registry-derived · unreviewed
- History of recurrent Clostridium difficile infection or FMT in the past 6-months.Registry-derived · unreviewed
- 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.Registry-derived · unreviewed
- Known history of bile acid diarrheaRegistry-derived · unreviewed
- 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)Registry-derived · unreviewed
- History of active cancer and/or ongoing chemotherapy (superficial non-metastatic cancers and maintenance chemotherapy are permitted).Registry-derived · unreviewed
- History of use of an investigational drug within 90 days prior to the screening visit.Registry-derived · unreviewed
- History of significant uncontrolled systemic disease that in the opinion of the study investigator could interfere with study participation and/or objectives.Registry-derived · unreviewed
- Life expectancy of \< 1 year.Registry-derived · unreviewed
- In the opinion of investigator, subject for any reason, should be excluded from the study.Registry-derived · unreviewed
This information can identify a possible match, conflict, or item needing confirmation. Only the study team can determine eligibility.
Study outcomes
Primary outcome
Patients in remission after administering 12 weeks of PRIM-DJ2727 capsules will be measured by partial Mayo score ≤ 3
Time frame: 9 months
Secondary outcome
Quality of life will be characterized by health-related quality of life score.
Time frame: 9 months
Secondary outcome
Subject-reported score in Hospital Anxiety and Depression Scale
Time frame: 9 months
After administering 12 weeks of PRIM-DJ2727
Recruiting locations in the United States
The University of Texas Health Science Center at Houston
RecruitingHouston, Texas, 77030, United States
Herbert L DuPont, MD713 500 9366herbert.l.dupont@uth.tmc.edu
Zhi-Dong Jiang, Dr.PH713 500 9371zhi-dong.jiang@uth.tmc.edu
Central study contacts
Registry dates
- First posted
- May 4, 2020
- Primary completion
- Dec 31, 2026
- Overall completion
- Dec 31, 2027
Trial information comes from ClinicalTrials.gov and may change. Confirm current status, eligibility, and site details with the study team. Aidy does not provide medical advice or determine eligibility.