RecruitingPhase 2NCT04373473

Evaluation the Safety and Efficacy of Lyophilized Fecal Microbiota Transplantation Administered Orally for Prevention of Relapse or Intestinal Inflammation in Adults With Ulcerative Colitis

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


Sponsor

The University of Texas Health Science Center, Houston

Enrollment

58 participants

Start Date

Sep 14, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether fecal microbiota transplantation (FMT) — transplanting gut bacteria from a healthy donor, given as oral capsules — can help prevent flare-ups in adults with ulcerative colitis who are currently in remission. The capsules are freeze-dried for convenience. **You may be eligible if...** - You are 18 or older - You have a history of active ulcerative colitis in the past 12 months - Your disease is currently in remission (mild or no symptoms) and stable on your current medications - You are willing to attend all study visits and take the capsules as instructed - You have a doctor who is providing your regular care for UC **You may NOT be eligible if...** - You cannot swallow multiple capsules - You are pregnant, breastfeeding, or planning to become pregnant during the study - You have taken systemic antibiotics in the last 2 weeks - You have HIV, active hepatitis B, or hepatitis C - You have a history of recurrent C. difficile infection or FMT in the past 6 months - You have other bowel conditions such as celiac disease, diverticulitis, or a colostomy - You have a weakened immune system or are on high-dose steroids - Your life expectancy is less than 1 year Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPRIM-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.

DRUGPlacebos

Placebo capsule will be identical to PRIM-DJ2727 but will not contain intestinal bacteria.


Locations(1)

The University of Texas Health Science Center at Houston

Houston, Texas, United States

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NCT04373473