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Phase 2
Phase 3
Age: 18Years - 65Years
All Genders
ID03804931

Study of Fecal Microbiota Transplantation to Treat Moderate to Severe Ulcerative Colitis in Adults Aged 18 to 65

Led by Guangzhou First People's Hospital · Updated on 2019-01-15

120

Participants Needed

1

Research Sites

104 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying fecal microbiota transplantation FMT as a treatment for patients with ulcerative colitis UC, a condition affecting the intestines. This research aims to evaluate the effectiveness and safety of FMT in restoring a healthy intestinal microbiome in people with active, moderate to severe UC. The trial is sponsored by Guangzhou First Peoples Hospital and includes patients aged 18 to 65 years. Participants will be randomly assigned to receive either FMT, an infusion of saline as a placebo, or traditional treatments including 5-Aminosalicylic acid 5-ASA andor Prednisone. The FMT involves injecting 200 mL of healthy donor fecal microbiota suspension into the intestine. Patients will receive at least two FMT treatments following established guidelines and will be followed for at least three months. During the study, patients will undergo evaluations including the Mayo score to assess clinical remission and improvement after 12 weeks. Researchers will also monitor changes in the intestinal microbiota. Participants must be able to undergo endoscopy and will be monitored for safety throughout the study. The total participation time includes treatment and follow-up periods to assess long-term effects and safety.

CONDITIONS

Brief Title

Fecal Microbiota Transplantation for Ulcerative Colitis

Research Team

H

Hongli Huang, MM

H

Huiting Chen, MM

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