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

N/AActive Not RecruitingNCT07149441

Shanghai 10th People's Hospital94 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

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

Interventions

Fecal microbiota transplantation (FMT) achieves the purpose of treating intestinal and extra-intestinal diseases by transplanting the functional microbes in the feces of healthy people into the patient's intestine through the upper or lower alimentary tract routes to rebuild the patient's intestinal microbiota.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Endoscopic remission rate

UC is endoscopic Mayo score 0-1; CD is simple endoscopic score (SES-CD)\<3 or no ulcer.

Time frame: 14th and 52nd week after joining the group.

Clinical remission rate

UC is defined as Mayo score ≤2, and no single score \> 1; CD is defined as CDAI (Crohn's disease activity index) \< 150.