Safety and Efficacy of Fecal Microbiota Transplantation

Not Applicable

Recruiting

• Conditions: Clostridium Difficile Infection; Atopy or Allergy; Psoriatic Arthropathy; Crohn Disease; Celiac Disease; Irritable Bowel Syndrome; Multidrug -Resistant Infection; Multiple Sclerosis; Pseudo-Obstruction; Idiopathic Thrombocytopenic Purpura
• Interventions: Procedure: Fecal Microbiota Transplantation

• Registration Number: NCT04014413
• Lead Sponsor: Chinese University of Hong Kong

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-21
• Study First Submitted QC: 2019-07-08
• Study First Posted: 2019-07-10
• Study Start: 2019-07-15
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-21
• Last Update Posted: 2024-08-22
• Primary Completion: 2030-10-31
• Study Completion: 2030-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

Confirmed diagnosis of any of the following diseases:

• Crohn's disease
• Ulcerative colitis
• Celiac disease
• Irritable bowel syndrome
• Functional dyspepsia
• Constipation
• Antibiotic-associated diarrhea or any antibiotic- associated complications/symptoms
• Metabolic syndrome such as diabetes mellitus and obesity
• Multidrug-resistant infection
• Hepatic encephalopathy
• Multiple sclerosis
• Pseudo-obstruction
• Carbapenem-resistant Enterobacteriaceae (CRE) or Vancomycin-resistant Enterococci (VRE) infection
• Multiple organ dysfunction
• Dysbiotic bowel syndrome
• MRSA enteritis
• Pseudomembranous enteritis
• Alopecia, autism
• Graft-versus-host disease
• Idiopathic thrombocytopenic purpura (ITP)
• Atopy or allergy
• Liver disease such as Nonalcoholic fatty liver disease (NAFLD) and Nonalcoholic steatohepatitis (NASH)
• Alcohol dependence
• Psoriatic arthropathy that has suboptimal control of disease despite standard treatment.

Exclusion Criteria

• Known contraindication to all FMT infusion method such as nasoduodenal tube insertion, oesophago-gastro-duodenoscopy (OGD), enteroscopy, colonoscopy and enema
• Any conditions that may render the efficacy of FMT or at the discretion of the investigators
• Current pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multidrug-resistant infection	Fecal Microbiota Transplantation	Fecal Microbiota Transplant will be performed.
Pseudo-obstruction	Fecal Microbiota Transplantation	Fecal Microbiota Transplant will be performed.
Irritable bowel syndrome	Fecal Microbiota Transplantation	Fecal Microbiota Transplant will be performed.
Celiac disease	Fecal Microbiota Transplantation	Fecal Microbiota Transplant will be performed.
Crohn's disease	Fecal Microbiota Transplantation	Fecal Microbiota Transplant will be performed.
Constipation	Fecal Microbiota Transplantation	Fecal Microbiota Transplant will be performed.
Hepatic encephalopathy	Fecal Microbiota Transplantation	Fecal Microbiota Transplant will be performed.
Multiple sclerosis	Fecal Microbiota Transplantation	Fecal Microbiota Transplant will be performed.
Multiple organ dysfunction	Fecal Microbiota Transplantation	Fecal Microbiota Transplant will be performed.
Pseudomembranous enteritis	Fecal Microbiota Transplantation	Fecal Microbiota Transplant will be performed.
CRE infection	Fecal Microbiota Transplantation	Fecal Microbiota Transplant will be performed.
VRE infection	Fecal Microbiota Transplantation	Fecal Microbiota Transplant will be performed.
Metabolic disease (diabetes mellitus or obesity)	Fecal Microbiota Transplantation	Fecal Microbiota Transplant will be performed.
Dysbiotic bowel syndrome	Fecal Microbiota Transplantation	Fecal Microbiota Transplant will be performed.
Alopecia	Fecal Microbiota Transplantation	Fecal Microbiota Transplant will be performed.
Ulcerative colitis	Fecal Microbiota Transplantation	Fecal Microbiota Transplant will be performed.
Functional dyspepsia	Fecal Microbiota Transplantation	Fecal Microbiota Transplant will be performed.
MRSA enteritis	Fecal Microbiota Transplantation	Fecal Microbiota Transplant will be performed.
Graft-versus-host disease	Fecal Microbiota Transplantation	Fecal Microbiota Transplant will be performed.
Idiopathic thrombocytopenic purpura	Fecal Microbiota Transplantation	Fecal Microbiota Transplant will be performed.
Autism	Fecal Microbiota Transplantation	Fecal Microbiota Transplant will be performed.
Atopy or allergy	Fecal Microbiota Transplantation	Fecal Microbiota Transplant will be performed.
Liver disease	Fecal Microbiota Transplantation	Fecal Microbiota Transplant will be performed.
Alcohol dependence	Fecal Microbiota Transplantation	Fecal Microbiota Transplant will be performed.
Antibiotic-associated diarrhea	Fecal Microbiota Transplantation	Fecal Microbiota Transplant will be performed.

Primary Outcome Measures

Name	Time	Method
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)	1 year

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0	1 year

Trial Locations

Locations (1)

The Chinese University of Hong Kong; 🇭🇰 Hong Kong, Shatin, Hong Kong