Safety and Efficacy of Fecal Microbiota Transplantation

Obesity Clinical Trial

Official title: Safety and Efficacy of Fecal Microbiota Transplantation: A Pilot Study

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism
• Alopecia
• Arthritis, Psoriatic
• Atopy or Allergy
• Autism
• Brain Diseases
• Carbapenem-Resistant Enterobacteriaceae Infection
• Celiac Disease
• Clostridium Difficile Infection
• Clostridium Infections
• Communicable Diseases
• Constipation
• Crohn Disease
• Diabetes Mellitus
• Dysbiotic Bowel Syndrome
• Dysphonia
• Enteritis
• Enterobacteriaceae Infections
• Enterocolitis
• Enterocolitis, Pseudomembranous
• Functional Dysphonia
• Graft vs Host Disease
• Graft-versus-host Disease
• Hepatic Encephalopathy
• Idiopathic Thrombocytopenic Purpura
• Infections
• Irritable Bowel Syndrome
• Liver Disease
• Liver Diseases
• MRSA Enteritis
• Multidrug -Resistant Infection
• Multiple Organ Dysfunction Syndrome
• Multiple Organ Failure
• Multiple Sclerosis
• Obesity
• Pseudo-Obstruction
• Pseudomembranous Enterocolitis
• Psoriatic Arthropathy
• Purpura
• Purpura, Thrombocytopenic
• Purpura, Thrombocytopenic, Idiopathic
• Syndrome
• Ulcerative Colitis
• Vancomycin Resistant Enterococci Infection

• NCT number: NCT04014413
• Study type: Interventional
• Source: Chinese University of Hong Kong
• Contact: Matthew Fung
• Phone: +852 35053855
• Email: mfung@cuhk.edu.hk
• Status: Recruiting
• Phase: N/A
• Start date: July 15, 2019
• Completion date: October 31, 2030