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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

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.


Condition or disease
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.


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Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: The Fecal Microbiota Transplantation Registry
Actual Study Start Date : July 2, 2017
Estimated Primary Completion Date : May 2046
Estimated Study Completion Date : November 2046

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

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.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. Promoting scientific investigation in FMT [ Time Frame: 10 years ]
    Collect study samples to characterize which microbiota favors FMT by metagenomics

  6. 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

  7. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03787771


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

Locations
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Hong Kong
Prince of Wales Hospital Recruiting
Hong Kong, Hong Kong
Contact: Siew Chien Ng, PhD    852 - 35053996    siewchienng@cuhk.edu.hk   
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
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Principal Investigator: Siew Chien Ng, PhD Chinese University of Hong Kong

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Responsible Party: Siew Chien NG, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT03787771     History of Changes
Other Study ID Numbers: FMTR
First Posted: December 25, 2018    Key Record Dates
Last Update Posted: December 25, 2018
Last Verified: December 2018

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

Keywords provided by Siew Chien NG, Chinese University of Hong Kong:
Fecal Microbiota Transplantation

Additional relevant MeSH terms:
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Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases