RecruitingPhase 1NCT05786404

Study to Evaluate the Fecal Microbiota Transplantation (FMT) in the Treatment of Ulcerative Colitis

A Randomized, Open-label, Pilot Study to Evaluate the Fecal Microbiota Transplantation (FMT) in the Treatment of Ulcerative Colitis


Sponsor

The University of Texas Health Science Center, Houston

Enrollment

20 participants

Start Date

Dec 15, 2023

Study Type

INTERVENTIONAL

Conditions

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. This study will also determine changes in microbiome (diversity and genera) and proportion of antibody-coated microbiota from baseline to after completion of FMT.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing fecal microbiota transplantation (FMT) — a treatment where stool from a healthy donor is transferred to a patient — as a way to treat active ulcerative colitis (UC), a chronic inflammatory bowel disease. Researchers want to see if FMT can help calm inflammation in the colon. **You may be eligible if...** - You have a diagnosis of active ulcerative colitis with moderate symptoms - You are willing and able to receive enemas or take capsules orally - You are not pregnant or breastfeeding and use effective birth control if applicable - You have an attending physician managing your non-FMT care **You may NOT be eligible if...** - Your ulcerative colitis is severe (high Mayo score) - You are pregnant or planning to become pregnant during the study - You have taken systemic antibiotics in the past 2 weeks - You have active HIV, Hepatitis B, or Hepatitis C - You have a history of other significant bowel conditions (IBS, celiac disease, Crohn's disease, colostomy, etc.) - You have a weakened immune system - You have had a previous FMT in the past 6 months 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 - FROZEN

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

DRUGPRIM-DJ2727 - CAPSULES

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.


Locations(1)

The University of Texas Health Science Center at Houston

Houston, Texas, United States

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NCT05786404


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