RecruitingNot ApplicableNCT04014413

Safety and Efficacy of Fecal Microbiota Transplantation

Safety and Efficacy of Fecal Microbiota Transplantation: A Pilot Study


Sponsor

Chinese University of Hong Kong

Enrollment

450 participants

Start Date

Jul 15, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Plain Language Summary

Simplified for easier understanding

This study is testing fecal microbiota transplantation (FMT) — a procedure where healthy donor stool is transferred to a patient to restore a balanced gut bacterial community — for a wide range of conditions linked to gut health problems. **You may be eligible if you have been diagnosed with any of the following:** - Crohn's disease or ulcerative colitis - Irritable bowel syndrome, celiac disease, or functional digestive problems - Antibiotic-associated diarrhea or C. difficile infection - Metabolic conditions like obesity or type 2 diabetes - Drug-resistant infections (MRSA, CRE, VRE) - Liver disease, hepatic encephalopathy, or graft-versus-host disease - Multiple sclerosis, autism spectrum disorder, or alopecia - Other conditions linked to disrupted gut bacteria **You may NOT be eligible if...** - You have conditions or circumstances that make the procedure unsafe - You are unable to consent or unable to comply with follow-up Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREFecal Microbiota Transplantation

Fecal microbiota transplantation


Locations(1)

The Chinese University of Hong Kong

Hong Kong, Shatin, Hong Kong

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NCT04014413


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