The Fecal Microbiota Transplantation Registry

Inflammatory Bowel Diseases Clinical Trial

Official title:

The Fecal Microbiota Transplantation Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03787771
• Other study ID #: FMTR
• Status: Recruiting
• Start date: July 2, 2017
• Est. completion date: November 2046

Study information

• Verified date: May 2023
• Source: Chinese University of Hong Kong
• Contact: Siew Chien Ng, PhD
• Phone: 852-35053996
• Email: siewchienng[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: November 2046
• Est. primary completion date: May 2046
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Patient outcome of FMT	Compare the severity of disease, any adverse event related to FMT and hospitalization between baseline and FMT. Survey	10 years
Secondary	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
Secondary	Characterize FMT stool donors and other gut-related microbiota products	Collect study samples to characterize which microbiota favors FMT by metagenomics	10 years
Secondary	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
Secondary	Promoting scientific investigation in FMT	Collect study samples to characterize which microbiota favors FMT by metagenomics	10 years
Secondary	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
Secondary	Developing Biobank of FMT	Collect and store of study samples from recipients and donors to characterize which microbiota favors FMT by metagenomics	10 years