The Fecal Microbiota Transplantation Registry

Recruiting

• Conditions: Inflammatory Bowel Diseases

• Registration Number: NCT03787771
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

The human intestinal microbiota is composed of complex community of 10\*13 to 10\*14 commensal microorganisms\[1\]. Human intestine provides a nutrient-rich habitat for intestinal microorganism which allows a diverse ecosystem to enhance their host's immune system and facilitate digestive activities. Numerous researches are investigating the role of gut microbiota in human homeostasis, which may be related to the pathogenesis of gastrointestinal disease and autoimmune disorder.

Fecal microbiota transplantation (FMT) is defined as infusion of feces from healthy donors to affected subjects. FMT works by altering the patient's microbiome and it is now recommended as an effective therapy for Clostridium difficile infection (CDI) not responding to standard therapies\[8\]. It has attracted great interest in recent years and many researches are exploring the FMT's potential role for treating other gastrointestinal disease such as IBD. A FMT registry is required to explore the relationship between disease prognosis and intestinal microbiota.

Detailed Description

The human intestinal microbiota is composed of complex community of 10\*13 to 10\*14 commensal microorganisms\[1\]. Human intestine provides a nutrient-rich habitat for intestinal microorganism which allows a diverse ecosystem to enhance their host's immune system and facilitate digestive activities. Numerous researches are investigating the role of gut microbiota in human homeostasis, which may be related to the pathogenesis of gastrointestinal disease and autoimmune disorder. A research using gene-sequencing technique showed an abnormal microbiota composition such as specific group of Escherichia coli and decreased diversity of intestinal microbiota in individuals with Inflammatory Bowel Disease (IBD) \[2-4\]. These microbiotas may stimulate the production of cytokine and chemokines that leads to the mucosal inflammatory activity\[5\]. Gut microbiota may also link with the development of obesity and diabetes by affecting host fat storage and increasing energy harvest from the diet\[6-7\].

Fecal microbiota transplantation (FMT) is defined as infusion of feces from healthy donors to affected subjects. FMT works by altering the patient's microbiome and it is now recommended as an effective therapy for Clostridium difficile infection (CDI) not responding to standard therapies8. It has attracted great interest in recent years and many researches are exploring the FMT's potential role for treating other gastrointestinal disease such as IBD. A recent clinical study evaluated the efficacy of FMT in active Ulcerative Colitis. It showed one-forth cases of the FMT group were in UC remission and an increase in diversity of microbiota composition. However, these results were dependent on the donor\[9\].

There will be increasing use of FMT in clinical practice, as well as more studies investigating the effectiveness of FMT on other diseases in the future. However, as an emerging procedure, there is currently no registry system to track patient safety information of FMT. It is also equally important to promote scientific investigation around gut microbiome. Therefore, the investigators aim to establish a FMT registry platform to collect clinical data and specimen from FMT recipients and donors. This registry is initiated Hong Kong, and will be expanded to other part of Asia.

Study Timeline

• Study Start: 2017-07-02
• Study First Submitted: 2018-06-27
• Study First Submitted QC: 2018-12-24
• Study First Posted: 2018-12-26
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-21
• Last Update Posted: 2024-08-22
• Primary Completion: 2046-05
• Study Completion: 2046-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

• Age ≥ 18
• Written informed consent obtained
• Subject who has received or planning to receive FMT or other gut-related microbiota products in routine clinical practice or research (FMT recipents)
• Subject who has donated stool or planning to donate stool for FMT or production of other gut-related microbiota products in routine clinical practice or research. Subjects who failed screening will also be recruited. (FMT donors)

Exclusion Criteria

• Age ≤18

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Set up a FMT registry	10 years	Set up a registry of FMT to collect data such as demographics, past medical history, surgery, severity of disease indicated for FMT cases

Secondary Outcome Measures

Name	Time	Method
Factors associated with successful FMT	10 years	Study samples will collected to characterize which microbiota favors FMT by performing metagenomics of gut microbiome in stool samples
Characterize FMT stool donors and other gut-related microbiota products	10 years	Collect study samples to characterize which microbiota favors FMT by metagenomics
Future research studies	10 years	Number of patients who may be eligible for participation in future research studies by collecting their information demographics, past medical history, surgery, severity of disease
Promoting scientific investigation in FMT	10 years	Collect study samples to characterize which microbiota favors FMT by metagenomics
Patient outcome of FMT	10 years	Compare the severity of disease, any adverse event related to FMT and hospitalization between baseline and FMT. Survey
FMT in Asia	10 years	Gather information such as the severity of disease, any adverse event related to FMT and hospitalization from other study sites in Asia. Survey
Developing Biobank of FMT	10 years	Collect and store of study samples from recipients and donors to characterize which microbiota favors FMT by metagenomics

Trial Locations

Locations (1)

Prince of Wales Hospital; 🇭🇰 Hong Kong, Hong Kong