The Fecal Microbiota Transplantation Registry

NCT03787771 | Recruiting

• 1 other identifier: FMTR
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Diseases

Keywords

Fecal Microbiota Transplantation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Patient outcome of FMT

  10 years

• Factors associated with successful FMT

  10 years

• Characterize FMT stool donors and other gut-related microbiota products

  10 years

• FMT in Asia

  10 years

• Promoting scientific investigation in FMT

  10 years

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• Age ≤18

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

RECRUITING

Related Publications (1)

• Yau YK, Lau LHS, Lui RNS, Wong SH, Guo CL, Mak JWY, Ching JYL, Ip M, Kamm MA, Rubin DT, Chan PKS, Chan FKL, Ng SC. Long-Term Safety Outcomes of Fecal Microbiota Transplantation: Real-World Data Over 8 Years From the Hong Kong FMT Registry. Clin Gastroenterol Hepatol. 2024 Mar;22(3):611-620.e12. doi: 10.1016/j.cgh.2023.09.001. Epub 2023 Sep 19.

  PMID: 37734581 DERIVED

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Siew Chien Ng, PhD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Siew Chien Ng, PhD

CONTACT

852-35053996; siewchienng@cuhk.edu.hk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 27, 2018
• First Posted: December 26, 2018
• Study Start: July 2, 2017
• Primary Completion (Estimated): May 1, 2046
• Study Completion (Estimated): November 1, 2046
• Last Updated: August 22, 2024

Record last verified: 2024-08

Locations

HK (1)