Step-up fecal microbiota transplantation strategy: a pilot study for steroid-dependent ulcerative colitis.
Bota Cui, Pan Li, Lijuan Xu...
https://pubmed.ncbi.nlm.nih.gov/26363929/Actively Recruiting
Led by Guangzhou First People's Hospital · Updated on 2019-01-15
120
Participants Needed
1
Research Sites
104 weeks
Total Duration
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
Fecal Microbiota Transplantation for Ulcerative Colitis
H
Hongli Huang, MM
H
Huiting Chen, MM
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Guangzhou First People's Hospital
Lead Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 weeks
Participants receive fecal microbiota transplantation or placebo at least two times according to study guidelines and may receive 5-Aminosalicylic acid and/or Prednisone as part of traditional treatment.
At least 2 treatment visits plus additional follow-up visits during treatment
Duration - At least 12 weeks
Participants are followed for at least three months after treatment to monitor clinical remission and intestinal microbiota changes.
Regular follow-up visits during the observation period
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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Bota Cui, Pan Li, Lijuan Xu...
https://pubmed.ncbi.nlm.nih.gov/26363929/Guangzhou First People's Hospital
Lead Sponsor