The Fecal Microbiota Transplantation Registry

• ClinicalTrials.gov Identifier: NCT03787771
• Recruitment Status: Recruiting
• First Posted: December 25, 2018
• Last Update Posted: December 25, 2018
• Sponsor: Chinese University of Hong Kong
• Information provided by (Responsible Party): Siew Chien NG, Chinese University of Hong Kong

Tracking Information

• First Submitted Date: June 27, 2018
• First Posted Date: December 25, 2018
• Last Update Posted Date: December 25, 2018
• Actual Study Start Date: July 2, 2017
• Estimated Primary Completion Date: May 2046 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 24, 2018)

Set up a FMT registry [ Time Frame: 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

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: December 24, 2018)

• Patient outcome of FMT [ Time Frame: 10 years ]
  Compare the severity of disease, any adverse event related to FMT and hospitalization between baseline and FMT. Survey
• Factors associated with successful FMT [ Time Frame: 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 [ Time Frame: 10 years ]
  Collect study samples to characterize which microbiota favors FMT by metagenomics
• FMT in Asia [ Time Frame: 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
• Promoting scientific investigation in FMT [ Time Frame: 10 years ]
  Collect study samples to characterize which microbiota favors FMT by metagenomics
• Future research studies [ Time Frame: 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
• Developing Biobank of FMT [ Time Frame: 10 years ]
  Collect and store of study samples from recipients and donors to characterize which microbiota favors FMT by metagenomics

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Fecal Microbiota Transplantation Registry
• Official Title: The Fecal Microbiota Transplantation Registry

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 Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Other
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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.

• Condition: Inflammatory Bowel Diseases
• Intervention: Not Provided

Study Groups/Cohorts

• 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.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: December 24, 2018): 3000
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: November 2046
• Estimated Primary Completion Date: May 2046 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Not Provided

Contacts

Contact: Siew Chien Ng, PhD; 852-35053996; siewchienng@cuhk.edu.hk

• Listed Location Countries: Hong Kong

Administrative Information

• NCT Number: NCT03787771
• Other Study ID Numbers: FMTR
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Responsible Party: Siew Chien NG, Chinese University of Hong Kong
• Study Sponsor: Chinese University of Hong Kong
• Collaborators: Not Provided

Investigators

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

• PRS Account: Chinese University of Hong Kong
• Verification Date: December 2018