Efficacy and Mechanism of Fecal Microbiota Transplantation in the Treatment of Inflammatory Bowel Disease: an Open-label Randomized Controlled Study
| Registry | NCT07149441 |
|---|---|
| Status | Active not recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 94 (Actual) |
| Sponsor | Shanghai 10th People's Hospital (Other) |
| Conditions | Inflammatory Bowel Disease (Crohn&Amp;#39;s Disease and Ulcerative Colitis), Fecal Microbiota Transplantation |
| Interventions | Fecal microbiota transplantation, infliximab (Procedure, drug) |
| Dates | start 2025-08-01, primary completion 2028-09-01 (estimated), completion 2028-09-01 (estimated), first posted 2025-09-02, last updated 2025-09-02 |
| Locations | 1 site in China |
Related Papers Related Patents Related Grants Related Experts
All trials for Inflammatory Bowel Disease (Crohn&Amp;#39;s Disease and Ulcerative Colitis) All trials for Fecal Microbiota Transplantation All trials of Fecal microbiota transplantation All trials of infliximab
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Biological agent +FMT | Experimental | Procedure: Fecal microbiota transplantation; Drug: infliximab | 47 patients were treated with biological agents combined with fecal microbiota transplants (FMT). All patients were followed up for 52 weeks after discharge. To observe the curative effect of FMT capsule treatment on UC or CD symptom-related scores of subjects and its remodeling effect on intestinal flora and verify its safety. |
| Biological agent | Experimental | Drug: infliximab | 47 patients were treated with biological agents. All patients were followed up for 52 weeks after discharge. To observe the curative effect of FMT capsule treatment on UC or CD symptom-related scores of subjects and its remodeling effect on intestinal flora and verify its safety. |
Sex: All, ages: 18 Years to 65 Years
Inclusion Criteria: * 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 Criteria: * 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.
| Facility | City | Country | Status |
|---|---|---|---|
| Shanghai Tenth People's Hospital | Shanghai, Shanghai Municipality | China |