Prince of Wales Hospital
Hong Kong
Location status: Recruiting
NCT Number: NCT03787771
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Hong Kong
Location status: Recruiting
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.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 10 years
Compare the severity of disease, any adverse event related to FMT and hospitalization between baseline and FMT. Survey
Time frame: 10 years
Study samples will collected to characterize which microbiota favors FMT by performing metagenomics of gut microbiome in stool samples
Time frame: 10 years
Collect study samples to characterize which microbiota favors FMT by metagenomics
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
Time frame: 10 years
Collect study samples to characterize which microbiota favors FMT by metagenomics
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
Time frame: 10 years
Collect and store of study samples from recipients and donors to characterize which microbiota favors FMT by metagenomics
Contact information is provided by the study sponsor or research team.
Chinese University of Hong Kong
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07012395
Colitis, Colitis, Ulcerative
Canoga Park, California, United States
View Trial DetailsNCT07456566
Colitis, Colitis, Ulcerative
Ann Arbor, Michigan, United States
View Trial DetailsNCT06188793
Digestive System Diseases, Gastroenteritis
Ann Arbor, Michigan, United States
View Trial DetailsNCT06226883
Crohn Disease, Crohn's Disease
Lancaster, California, United States
View Trial Details