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/26363929Actively Recruiting
Phase 2
Phase 3
Age: 18Years - 65Years
All Genders
ID03804931
Efficacy and Safety of Fecal Microbiota Transplantation for Ulcerative Colitis
Led by Guangzhou First People's Hospital · Updated on 2019-01-15
120
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
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 People's 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) and/or 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
Who Can Participate
Age: 18Years - 65Years
All Genders
Eligibility Criteria
You may qualify if you...
- Active, moderate to severe ulcerative colitis with Mayo score more than 6
- History of safe use of 5-Aminosalicylic acid (5-ASA)
- Ability to undergo endoscopy examination
- Age between 18 and 65 years
You will not qualify if you...
- Use of antibiotics within the last 7 days
- High risk of toxic megacolon
- Colon cancer or neoplasia detected
- Presence of other severe diseases such as cardiovascular, respiratory, gastrointestinal, or kidney diseases
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
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
Follow-up
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
Trial Site Locations
Total: 1 location
1
Guangzhou First People's Hospital
Guangzhou, Guangdong, China
Actively Recruiting
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Research Team
H
Hongli Huang, MM
H
Huiting Chen, MM
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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