Fecal microbiota transplantation for treating inflammatory bowel disease
A Multicenter Clinical Trial: Efficacy, Safety of Fecal Microbiota Transplantation for Inflammatory Bowel Disease
This study is testing whether a new treatment using fecal microbiota transplantation can help people with ulcerative colitis feel better and improve their gut health.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Zhongshan Hospital Xiamen University Academic / other |
| Locations | 1 site (Xiamen) |
| Trial ID | NCT04521205 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the efficacy and safety of fecal microbiota transplantation (FMT) as a treatment for inflammatory bowel disease (IBD), specifically ulcerative colitis. The study will involve a randomized, single-blind design where patients will receive standardized FMT via capsules or continue with their current treatment. Participants will be monitored for clinical symptoms, laboratory tests, and changes in intestinal microbiota over a follow-up period of at least one year. The aim is to assess the effectiveness of FMT in restoring gut microbiota balance and improving patient outcomes.
Who should consider this trial
Good fit: Ideal candidates include IBD patients with recurrent symptoms or those who have not responded to standard treatments.
Not a fit: Patients with contraindications for gastrointestinal endoscopy or those with serious comorbid conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new, effective option for patients with IBD who do not respond to conventional therapies.
How similar studies have performed: Previous studies have shown promising results for fecal microbiota transplantation in treating IBD, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Standard or conventional medicine treatment ineffective of IBD patients 2. IBD patients with recurrent symptoms 3. IBD patients who had drug dependence or recurrence when reduced or discontinued use 4. Untreated IBD patients who voluntarily received FMT Exclusion Criteria: 1. IBD patients with contraindications for gastrointestinal endoscopy 2. IBD patients combined with other serious diseases such as respiratory failure, heart failure and severe immunodeficiency 3. IBD patients with indication of surgery
Where this trial is running
Xiamen
- Yanyun Fan — Xiamen, China (Recruiting)
Study contacts
- Study coordinator: Yanyun Fan, Doctor
- Email: trudy@163.com
- Phone: 18759212670
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.