An interventional study of Fecal Microbiota Transplantation in Crohn Disease, Ulcerative Colitis and Celiac Disease, sponsored by Chinese University of Hong Kong. Recruiting at 1 site in Hong Kong. Per ClinicalTrials.gov, last updated 2024-08-22.
Sponsored by Chinese University of Hong Kong · Not applicable, Interventional, and Treatment
The gut microbiota is critical to health and functions with a level of complexity comparable to that of an organ system. Dysbiosis, or alterations of this gut microbiota ecology, have been implicated in a number of disease states. Fecal microbiota transplantation (FMT), defined as infusion of feces from healthy donors to affected subjects, is a method to restore a balanced gut microbiota and has attracted great interest in recent years due to its efficacy and ease of use. FMT is now recommended as the most effective therapy for CDI not responding to standard therapies.
Recent studies have suggested that dysbiosis is associated with a variety of disorders, and that FMT could be a useful treatment. Randomized controlled trial has been conducted in a number of disorders and shown positive results, including alcoholic hepatitis, Crohn's disease (CD), ulcerative colitis (UC), pouchitis, irritable bowel syndrome (IBS), hepatic encephalopathy and metabolic syndrome. Case series/reports and pilot studies has shown positive results in other disorders including Celiac disease, functional dyspepsia, constipation, metabolic syndrome such as diabetes mellitus, multidrug-resistant, hepatic encephalopathy, multiple sclerosis, pseudo-obstruction, carbapenem-resistant Enterobacteriaceae (CRE) or Vancomycin-resistant Enterococci (VRE) infection, radiation-induced toxicity, multiple organ dysfunction, dysbiotic bowel syndrome, MRSA enteritis, Pseudomembranous enteritis, idiopathic thrombocytopenic purpura (ITP), and atopy.
Despite FMT appears to be relatively safe and efficacious in treating a wide range of disease, its safety and efficacy in a usual clinical setting is unknown. More data is required to confirm safety and efficacy of FMT. Therefore, the investigators aim to conduct a pilot study to investigate the efficacy and safety of FMT in a variety of dysbiosis-associated disorder.
1,992 studies on the registry are indexed under Crohn Disease; 478 are open to participants now.
This study's planned enrollment of 450 is above the median of 67 across 1,260 interventional studies indexed under Crohn Disease.
Browse Crohn Disease studies →Chinese University of Hong Kong is the lead sponsor of 1,454 studies on the registry; 474 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Confirmed diagnosis of any of the following diseases:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
GVHD (graft-versus-host disease)
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Fecal Microbiota Transplant will be performed.
Procedure: Fecal Microbiota Transplantation
Fecal Microbiota Transplant will be performed.
Procedure: Fecal Microbiota Transplantation
Fecal Microbiota Transplant will be performed.
Procedure: Fecal Microbiota Transplantation
Fecal Microbiota Transplant will be performed.
Procedure: Fecal Microbiota Transplantation
Fecal Microbiota Transplant will be performed.
Procedure: Fecal Microbiota Transplantation
Fecal Microbiota Transplant will be performed.
Procedure: Fecal Microbiota Transplantation
Fecal Microbiota Transplant will be performed.
Procedure: Fecal Microbiota Transplantation
Fecal Microbiota Transplant will be performed.
Procedure: Fecal Microbiota Transplantation
Fecal Microbiota Transplant will be performed.
Procedure: Fecal Microbiota Transplantation
Fecal Microbiota Transplant will be performed.
Procedure: Fecal Microbiota Transplantation
Fecal Microbiota Transplant will be performed.
Procedure: Fecal Microbiota Transplantation
Fecal Microbiota Transplant will be performed.
Procedure: Fecal Microbiota Transplantation
Fecal Microbiota Transplant will be performed.
Procedure: Fecal Microbiota Transplantation
Fecal Microbiota Transplant will be performed.
Procedure: Fecal Microbiota Transplantation
Fecal Microbiota Transplant will be performed.
Procedure: Fecal Microbiota Transplantation
Fecal Microbiota Transplant will be performed.
Procedure: Fecal Microbiota Transplantation
Fecal Microbiota Transplant will be performed.
Procedure: Fecal Microbiota Transplantation
Fecal Microbiota Transplant will be performed.
Procedure: Fecal Microbiota Transplantation
Fecal Microbiota Transplant will be performed.
Procedure: Fecal Microbiota Transplantation
Fecal Microbiota Transplant will be performed.
Procedure: Fecal Microbiota Transplantation
Fecal Microbiota Transplant will be performed.
Procedure: Fecal Microbiota Transplantation
Fecal Microbiota Transplant will be performed.
Procedure: Fecal Microbiota Transplantation
Fecal Microbiota Transplant will be performed.
Procedure: Fecal Microbiota Transplantation
Fecal Microbiota Transplant will be performed.
Procedure: Fecal Microbiota Transplantation
Fecal Microbiota Transplant will be performed.
Procedure: Fecal Microbiota Transplantation
Fecal microbiota transplantation
The efficacy of FMT in treating dysbiosis-associated disorder will be assessed by number of patients who have improvement in clinical symptoms (depends on each disease as stated in outcome)
Time frame: 1 year
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Time frame: 1 year
Any improvement or deterioration or recurrence of the underlying condition by clinical judgement of doctors
Time frame: 1 year
Plan to share: No
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