NCT04014413

Safety and Efficacy of Fecal Microbiota Transplantation

Safety and Efficacy of Fecal Microbiota Transplantation: A Pilot Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 450 (estimated)
• Sponsor: Chinese University of Hong Kong · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
PROCEDURE	Fecal Microbiota Transplantation	Fecal microbiota transplantation

Timeline

• Start date: 2019-07-15
• Primary completion: 2030-10-31
• Completion: 2030-10-31
• First posted: 2019-07-10
• Last updated: 2024-08-22

Locations

1 site across 1 country: Hong Kong