NCT07149441Active, not recruiting
Efficacy and Mechanism of FMT in the Treatment of Inflammatory Bowel Disease: an Open-label Randomized Controlled Study
Efficacy and Mechanism of Fecal Microbiota Transplantation in the Treatment of Inflammatory Bowel Disease: an Open-label Randomized Controlled Study
Source: ClinicalTrials.gov · Last updated 2 Sept 2025
Brief summary (registry, in English)
This study enrolled 94 patients with UC or CD. Two groups received either 8-week intestinal bacterial transplant capsule therapy or biological therapy, respectively. The control group received biological therapy alone, while the experimental group received biological therapy combined with FMT. Both groups were followed up for 52 weeks after discharge. The efficacy of FMT capsule therapy on the subjects' UC or CD symptom-related scores and its effect on remodeling the intestinal flora were observed, and its safety was verified.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 94 (actual)
- First submitted
- 24 Aug 2025
- Start date
- 1 Aug 2025
- Primary completion date
- 1 Sept 2028
- Lead sponsor
- Shanghai 10th People's Hospital
- Diseases
- Crohn's disease, Ulcerative colitis
- NCT number
- NCT07149441
What you commit to
- Study type: Interventional
- Participants enrolled: 94
- From 1 Aug 2025 to the primary completion date, 1 Sept 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Biological agents (such as anti-TNF-α drugs, vedolizumab, etc.) were used in the past, but no clinical remission was achieved.
- Can tolerate oral enterobacteria transplantation capsule treatment.
Age
- Adults aged 18-65.
Other
- The diagnosis was UC or CD, and the diagnosis was based on clinical, endoscopic and pathological evidence.
- IBD should be diagnosed for at least 6 months to rule out the possibility of natural remission of new cases.
- Patients should be in mild to moderate active stage (UC: Mayo score 3-10; CD: CDAI score: 150-449)
- Voluntary participation and signing of informed consent.
Who the study is looking for
- The diagnosis was UC or CD, and the diagnosis was based on clinical, endoscopic and pathological evidence.
- IBD should be diagnosed for at least 6 months to rule out the possibility of natural remission of new cases.
- Patients should be in mild to moderate active stage (UC: Mayo score 3-10; CD: CDAI score: 150-449)
- Biological agents (such as anti-TNF-α drugs, vedolizumab, etc.) were used in the past, but no clinical remission was achieved.
- Voluntary participation and signing of informed consent.
- Adults aged 18-65.
- Can tolerate oral enterobacteria transplantation capsule treatment.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Tenth People's Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.