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

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.

Study Overview

• Status: Recruiting
• Conditions: Inflammatory Bowel Disease, Ulcerative Colitis Type
• Intervention / Treatment: Drug: fecal microbiota capsule

Detailed Description

In this projects the investigators aim to re-establish a gut balance of intestinal microbiota through Standardized Fecal Microbiota Transplantation for IBD (UC and CD). We have established a standardized isolation, store, and transport steps of fecal bacteria from donated fresh stool in the laboratory. Then the bacteria will be transplanted to mid-gut by capsule. Patients in this study will be assigned to receive standardized FMT three times or not and would be followed up for at least 1 year. The clinical symptoms, sign, blood tests, endoscopy and questionnaire will be used to assess the efficiency, durability and safety of Standardized FMT at the start and end of the projects. At last, we will use 16S-rDNA to estimate the change of intestinal microbiota.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Yanyun Fan, Doctor; Phone Number: 18759212670; Email: trudy@163.com

Study Locations

• China
  • Xiamen, China
    • Recruiting
    • Yanyun Fan
    • Contact: Yanyun Fan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Standardized FMT; The patients will receive standardized FMT. The FMT was given by capsule. It was given three times a week.	Drug: fecal microbiota capsule; a capsule full of fecal microbiota extracting from the health
Placebo Comparator: Without FMT; The patients will receive FMT with blank capsule.	Drug: fecal microbiota capsule; a capsule full of fecal microbiota extracting from the health

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Zhongshan Hospital Xiamen University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Estimated): December 30, 2023
• Study Completion (Estimated): April 30, 2024

Study Registration Dates

• First Submitted: August 18, 2020
• First Submitted That Met QC Criteria: August 18, 2020
• First Posted (Actual): August 20, 2020

Study Record Updates

• Last Update Posted (Estimated): November 14, 2023
• Last Update Submitted That Met QC Criteria: November 11, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Colitis; Inflammatory Bowel Diseases; Intestinal Diseases; Colitis, Ulcerative
• Other Study ID Numbers: XMZSYY-AF-SC-12-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No