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

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.

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.