UCRecruiting
Evaluation the Safety and Efficacy of Lyophilized Fecal Microbiota Transplantation Administered Orally for Prevention of Relapse or Intestinal Inflammation in Adults With Ulcerative Colitis
Phase 2 · Testing PRIM-DJ2727 · 1 site · The University of Texas Health Science Center, Houston
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing PRIM-DJ2727 (a drug) as a possible treatment. Condition(s) listed: Adults With Ulcerative Colitis.
Participants are assigned to groups by chance (randomized).
Some participants receive a placebo or sham for comparison.
It is blinded: participants and the study team do not know who receives what.
Phase 2 studies test whether a treatment shows signs of working, and keep checking safety, in a larger group of people with the condition.
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- Adult ≥18 years of age
- History of active UC in the past 12 months based on standard clinical, endoscopic, or histologic criteria.
- Remission of UC based on clinical grounds (partial Mayo score of ≤2 with each subscore ≤1), and on stable maintenance therapy.
Plus 4 more requirement(s). There are also 13 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 58 participants are expected to take part.
- Start date: 2020-09-14.
- Main results expected around 2026-12-31 (estimate from the record).
- 1 study site listed (1 marked recruiting) in United States.
Main thing being measured
- Patients in remission after administering 12 weeks of PRIM-DJ2727 capsules will be measured by partial Mayo score ≤ 3 (9 months)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Phase 2 |
| Study type | Interventional |
| Conditions | Adults With Ulcerative Colitis |
| Lead sponsor | The University of Texas Health Science Center, Houston |
| Enrollment | 58 (estimated) |
| Start date | 2020-09-14 |
| Primary completion (est.) | 2026-12-31 |
| First posted | 2020-05-04 |
| Last updated | 2026-03-09 |
| Official title | A Phase 2a, Randomized, Double-blinded, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Lyophilized Fecal Microbiota Transplantation (PRIM-DJ2727) Administered Orally in Combination With Standard of Care Therapy for Prevention of Relapse or Intestinal Inflammation in Adults With Ulcerative Colitis |
| ClinicalTrials.gov ID | NCT04373473 |
Interventions
- PRIM-DJ2727 (Drug)
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. - Placebos (Drug)
Placebo capsule will be identical to PRIM-DJ2727 but will not contain intestinal bacteria.
Full eligibility criteria (from the record)
Inclusion Criteria: 1. Adult ≥18 years of age 2. History of active UC in the past 12 months based on standard clinical, endoscopic, or histologic criteria. 3. Remission of UC based on clinical grounds (partial Mayo score of ≤2 with each subscore ≤1), and on stable maintenance therapy. 4. Sexually active male and female subjects of childbearing potential must agree to use an effective method of birth control during the study. 5. 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. 6. Willing and able to sign an informed consent form and attend all study-related clinic visits, assessments, and follow-up phone calls. 7. Subject has an attending physician who will provide the non-FMT care. Exclusion Criteria: 1. Unable to take multiple capsules orally. 2. Females who are pregnant, breastfeeding, or planning to become pregnant during the study. 3. Receipt of systemic non-topical antibiotics within 14 days of treatment day 1. 4. Positive results for active HIV, Hepatitis B, or Hepatitis C infections. 5. History of recurrent Clostridium difficile infection or FMT in the past 6-months. 6. 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. 7. Known history of bile acid diarrhea 8. 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) 9. History of active cancer and/or ongoing chemotherapy (superficial non-metastatic cancers and maintenance chemotherapy are permitted). 10. History of use of an investigational drug within 90 days prior to the screening visit. 11. History of significant uncontrolled systemic disease that in the opinion of the study investigator could interfere with study participation and/or objectives. 12. Life expectancy of < 1 year. 13. In the opinion of investigator, subject for any reason, should be excluded from the study.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston, Texas | United States | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.