Status:
ACTIVE_NOT_RECRUITING
Efficacy and Mechanism of FMT in the Treatment of Inflammatory Bowel Disease: an Open-label Randomized Controlled Study
Lead Sponsor:
Shanghai 10th People's Hospital
Conditions:
Inflammatory Bowel Disease (Crohn&Amp;#39;s Disease and Ulcerative Colitis)
Fecal Microbiota Transplantation
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
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 biologi...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
August 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2028
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT07149441
Start Date
August 1 2025
End Date
September 1 2028
Last Update
September 2 2025
Active Locations (1)
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1
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, China