The Fecal Microbiota Transplantation Registry

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.

Study Overview

• Status: Recruiting
• Conditions: Inflammatory Bowel Diseases

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 Type: Observational
• Enrollment (Estimated): 3000

Contacts and Locations

• Study Contact: Name: Siew Chien Ng, PhD; Phone Number: 852-35053996; Email: siewchienng@cuhk.edu.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • Prince of Wales Hospital
    • Contact: Siew Chien Ng, PhD; Phone Number: 852 - 35053996; Email: siewchienng@cuhk.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

FMT Recipients Subject who has received or planning to receive FMT or other gut-related microbiota products in routine clinical practice or research

FMT Donors 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
FMT recipents; Subject who has received or planning to receive FMT or other gut-related microbiota products in routine clinical practice or research
FMT donors; 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient outcome of FMT	Compare the severity of disease, any adverse event related to FMT and hospitalization between baseline and FMT. Survey	10 years
Factors associated with successful FMT	Study samples will collected to characterize which microbiota favors FMT by performing metagenomics of gut microbiome in stool samples	10 years
Characterize FMT stool donors and other gut-related microbiota products	Collect study samples to characterize which microbiota favors FMT by metagenomics	10 years
FMT in Asia	Gather information such as the severity of disease, any adverse event related to FMT and hospitalization from other study sites in Asia. Survey	10 years
Promoting scientific investigation in FMT	Collect study samples to characterize which microbiota favors FMT by metagenomics	10 years
Future research studies	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	10 years
Developing Biobank of FMT	Collect and store of study samples from recipients and donors to characterize which microbiota favors FMT by metagenomics	10 years

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Siew Chien Ng, PhD, Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2017
• Primary Completion (Estimated): May 1, 2046
• Study Completion (Estimated): November 1, 2046

Study Registration Dates

• First Submitted: June 27, 2018
• First Submitted That Met QC Criteria: December 24, 2018
• First Posted (Actual): December 26, 2018

Study Record Updates

• Last Update Posted (Actual): August 22, 2024
• Last Update Submitted That Met QC Criteria: August 21, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Fecal Microbiota Transplantation
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases
• Other Study ID Numbers: FMTR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No