A Multicenter Clinical Trial: Efficacy, Safety of Fecal Microbiota Transplantation for Inflammatory Bowel Disease

NCT04521205 | Unknown Phase 1 DMC

• 1 other identifier: XMZSYY-AF-SC-12-03
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

There are many limitations in the current treatments of Inflammatory bowel disease(IBD). Some patients have no or little reaction to the traditional drugs. Now the investigators realized that the intestinal microbiota is closely associated with the development of IBD. In recent years, a retrospective study showed that the overall efficiency of fecal microbiota transplantation (FMT) for IBD was 79%, the overall remission rate was 43%, which opened a new chapter in the treatment of IBD. So the standardized fecal microbiota transplantation is considered to be simple but effective emerging therapies for the treatment of IBD. In this project the investigators intend to carry out a single-center, randomized, single-blind clinical intervention study. The investigators plan to recruit patients with IBD (Ulcerative Colitis and Crohn's Disease) in China. The patients will be randomly divided into two groups, one group will be given treatment of standardized fecal microbiota transplantation, the other will be simply treated with traditional drugs, followed up for at least 1 year. The investigators aim to determine the efficiency, durability and safety of Fecal Microbiota Transplantation for IBD treatment, and further to explore which major microbiota may effect in this project.

Conditions

Inflammatory Bowel Disease, Ulcerative Colitis Type

Outcome Measures

Primary Outcomes (1)

• Clinical remission: the modified Mayo score and endoscopy

  Clinical remission defined as modified Mayo score≦2 (range 0-12). The endpoint of follow-up is the time of clinical recurrence. The higher scores mean a worse outcome.

  up to one year

Study Arms (2)

Standardized FMT

EXPERIMENTAL

The patients will receive standardized FMT. The FMT was given by capsule. It was given three times a week.

Drug: fecal microbiota capsule

Without FMT

PLACEBO COMPARATOR

The patients will receive FMT with blank capsule.

Drug: fecal microbiota capsule

Interventions

fecal microbiota capsule DRUG

a capsule full of fecal microbiota extracting from the health

Standardized FMT; Without FMT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Standard or conventional medicine treatment ineffective of IBD patients
• IBD patients with recurrent symptoms
• IBD patients who had drug dependence or recurrence when reduced or discontinued use
• Untreated IBD patients who voluntarily received FMT

You may not qualify if:

• IBD patients with contraindications for gastrointestinal endoscopy
• IBD patients combined with other serious diseases such as respiratory failure, heart failure and severe immunodeficiency
• IBD patients with indication of surgery

Sponsors & Collaborators

• Zhongshan Hospital Xiamen University: lead

Study Sites (1)

Yanyun Fan

Xiamen, China

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Central Study Contacts

Yanyun Fan, Doctor

CONTACT

18759212670; trudy@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2020
• First Posted: August 20, 2020
• Study Start: December 1, 2020
• Primary Completion: December 30, 2023
• Study Completion: April 30, 2024
• Last Updated: November 14, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)