UCRecruiting
Study to Evaluate the Fecal Microbiota Transplantation (FMT) in the Treatment of Ulcerative Colitis
Phase 1 · Testing PRIM-DJ2727 - FROZEN and PRIM-DJ2727 - CAPSULES · 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 - FROZEN (a drug) and PRIM-DJ2727 - CAPSULES (a drug) as a possible treatment. Condition(s) listed: Active Ulcerative Colitis (UC).
Participants are assigned to groups by chance (randomized).
It is open-label: participants know what they are receiving.
Phase 1 studies are early tests in a small group of people, mainly checking safety and dosing.
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- 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.
Plus 2 more requirement(s). There are also 15 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 20 participants are expected to take part.
- Start date: 2023-12-15.
- Main results expected around 2026-12-15 (estimate from the record).
- 1 study site listed (1 marked recruiting) in United States.
Main thing being measured
- Disease severity as assessed by the Partial Mayo Score (PMS) for Ulcerative Colitis (UC) (week 5)
In the researchers’ words
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.
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 1 |
| Study type | Interventional |
| Conditions | Active Ulcerative Colitis (UC) |
| Lead sponsor | The University of Texas Health Science Center, Houston |
| Enrollment | 20 (estimated) |
| Start date | 2023-12-15 |
| Primary completion (est.) | 2026-12-15 |
| First posted | 2023-03-27 |
| Last updated | 2024-05-10 |
| 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 |
Interventions
- PRIM-DJ2727 - FROZEN (Drug)
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 froz… - PRIM-DJ2727 - CAPSULES (Drug)
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.
Full eligibility criteria (from the record)
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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
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.