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The Fecal Microbiota Transplantation Registry

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ClinicalTrials.gov Identifier: NCT03787771
Recruitment Status : Recruiting
First Posted : December 25, 2018
Last Update Posted : December 25, 2018
Sponsor:
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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