Inflammatory Bowel Diseases Clinical Trial
Official title:
The Fecal Microbiota Transplantation Registry
NCT number | NCT03787771 |
Other study ID # | FMTR |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | July 2, 2017 |
Est. completion date | November 2046 |
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.
Status | Recruiting |
Enrollment | 3000 |
Est. completion date | November 2046 |
Est. primary completion date | May 2046 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Hong Kong | Prince of Wales Hospital | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
Chinese University of Hong Kong |
Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Patient outcome of FMT | Compare the severity of disease, any adverse event related to FMT and hospitalization between baseline and FMT. Survey | 10 years | |
Secondary | Factors associated with successful FMT | Study samples will collected to characterize which microbiota favors FMT by performing metagenomics of gut microbiome in stool samples | 10 years | |
Secondary | Characterize FMT stool donors and other gut-related microbiota products | Collect study samples to characterize which microbiota favors FMT by metagenomics | 10 years | |
Secondary | FMT in Asia | Gather information such as the severity of disease, any adverse event related to FMT and hospitalization from other study sites in Asia. Survey | 10 years | |
Secondary | Promoting scientific investigation in FMT | Collect study samples to characterize which microbiota favors FMT by metagenomics | 10 years | |
Secondary | Future research studies | 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 | 10 years | |
Secondary | Developing Biobank of FMT | Collect and store of study samples from recipients and donors to characterize which microbiota favors FMT by metagenomics | 10 years |
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