Clinical trial NCT03787771: The Fecal Microbiota Transplantation Registry
Official title: The Fecal Microbiota Transplantation Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Inflammatory Bowel Diseases
Keywords: Fecal Microbiota Transplantation
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2018-12-26
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
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.

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.

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

Primary outcomes:
measure: Set up a FMT registry
timeFrame: 10 years
Secondary outcomes:
measure: Patient outcome of FMT
timeFrame: 10 years
measure: Factors associated with successful FMT
timeFrame: 10 years
measure: Characterize FMT stool donors and other gut-related microbiota products
timeFrame: 10 years
measure: FMT in Asia
timeFrame: 10 years
measure: Promoting scientific investigation in FMT
timeFrame: 10 years
measure: Future research studies
timeFrame: 10 years
measure: Developing Biobank of FMT
timeFrame: 10 years
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
Study officials:
affiliation: Chinese University of Hong Kong
name: Siew Chien Ng, PhD
role: PRINCIPAL_INVESTIGATOR
References: