Safety and Efficacy of Fecal Microbiota Transplantation

Sponsor

Chinese University of Hong Kong (Other)

Overall Status

Recruiting

CT.gov ID

NCT04014413

Collaborator

(none)

450

Enrollment

Location

Arms

63.6

Anticipated Duration (Months)

7.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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	Procedure: Fecal Microbiota Transplantation	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

450 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Safety and Efficacy of Fecal Microbiota Transplantation: A Pilot Study

Actual Study Start Date :

Jul 15, 2019

Anticipated Primary Completion Date :

Oct 31, 2023

Anticipated Study Completion Date :

Oct 31, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0 [1 year]

Other Outcome Measures

Any improvement or deterioration or recurrence of the underlying condition by clinical judgement of doctors [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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