NCT04521205

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

Status unknown Phase 1 Last updated 14 November 2023

What this trial tests

Phase 1 trial testing fecal microbiota capsule in Inflammatory Bowel Disease, Ulcerative Colitis Type in 200 participants. Status unknown.

Timeline

1 December 2020

Primary endpoint
30 December 2023

30 April 2024

Quick facts

Lead sponsor	Zhongshan Hospital Xiamen University
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	200
Start date	1 December 2020
Primary completion	30 December 2023
Estimated completion	30 April 2024
Sites	1 location across China

Drugs / interventions tested

• fecal microbiota capsule

Conditions studied

• Inflammatory Bowel Disease, Ulcerative Colitis Type — all drugs for Inflammatory Bowel Disease, Ulcerative Colitis Type →

Sponsor

Zhongshan Hospital Xiamen University

Who can join

Adults 18 to 65, any sex, with Inflammatory Bowel Disease, Ulcerative Colitis Type. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Fecal transplantation for treatment of inflammatory bowel disease.
   Imdad A, Pandit NG, Zaman M, Minkoff NZ, et al · · 2023 · cited 51× · PMID 37094824 · DOI 10.1002/14651858.cd012774.pub3
2. Nanocomposite Biomaterials for Tissue-Engineered Hernia Repair: A Review of Recent Advances.
   Andronic O, Palcau AC, Bolocan A, Dinulescu A, et al · · 2025 · cited 1× · PMID 41008655 · DOI 10.3390/biom15091348