Efficacy and Mechanism of FMT in the Treatment of Inflammatory Bowel Disease: an Open-label Randomized Controlled Study

Tongji University

Status: Active, not recruiting

Conditions: Inflammatory Bowel Disease (Crohn&Amp;#39;s Disease and Ulcerative Colitis); Fecal Microbiota Transplantation

Treatments: Procedure: Fecal microbiota transplantation; Drug: infliximab

Study type: Interventional

Funder types: Other

Identifiers

NCT07149441

FMT-IBD

Details and patient eligibility

About

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.

Enrollment: 94 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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94 participants in 2 patient groups

Biological agent +FMT

Experimental group

Description:

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.

Treatment:

Drug: infliximab

Procedure: Fecal microbiota transplantation

Biological agent

Experimental group

Description:

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.

Treatment:

Drug: infliximab