Safety and Efficacy of Fecal Microbiota Transplantation

Safety and Efficacy of Fecal Microbiota Transplantation: A Pilot Study

Sponsors

Lead Sponsor: Chinese University of Hong Kong

Source 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.

Overall Status Recruiting
Start Date July 15, 2019
Completion Date October 31, 2024
Primary Completion Date October 31, 2023
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
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
Measure Time Frame
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0 1 year
Enrollment 450
Condition
Intervention

Intervention Type: Procedure

Intervention Name: Fecal Microbiota Transplantation

Description: Fecal microbiota transplantation

Eligibility

Criteria:

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

Gender: All

Minimum Age: N/A

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Siew Ng Principal Investigator Chinese University of Hong Kong
Overall Contact

Last Name: Kitty Cheung

Phone: +852 26373260

Email: [email protected]

Location
Facility: Status: The Chinese University of Hong Kong
Location Countries

Hong Kong

Verification Date

April 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Chinese University of Hong Kong

Investigator Full Name: Siew Chien NG

Investigator Title: Professor

Has Expanded Access No
Condition Browse
Number Of Arms 25
Arm Group

Label: Crohn's disease

Type: Experimental

Description: Fecal Microbiota Transplant will be performed.

Label: Ulcerative colitis

Type: Experimental

Description: Fecal Microbiota Transplant will be performed.

Label: Celiac disease

Type: Experimental

Description: Fecal Microbiota Transplant will be performed.

Label: Irritable bowel syndrome

Type: Experimental

Description: Fecal Microbiota Transplant will be performed.

Label: Functional dyspepsia

Type: Experimental

Description: Fecal Microbiota Transplant will be performed.

Label: Constipation

Type: Experimental

Description: Fecal Microbiota Transplant will be performed.

Label: Metabolic disease (diabetes mellitus or obesity)

Type: Experimental

Description: Fecal Microbiota Transplant will be performed.

Label: Multidrug-resistant infection

Type: Experimental

Description: Fecal Microbiota Transplant will be performed.

Label: Hepatic encephalopathy

Type: Experimental

Description: Fecal Microbiota Transplant will be performed.

Label: Multiple sclerosis

Type: Experimental

Description: Fecal Microbiota Transplant will be performed.

Label: Pseudo-obstruction

Type: Experimental

Description: Fecal Microbiota Transplant will be performed.

Label: CRE infection

Type: Experimental

Description: Fecal Microbiota Transplant will be performed.

Label: VRE infection

Type: Experimental

Description: Fecal Microbiota Transplant will be performed.

Label: Multiple organ dysfunction

Type: Experimental

Description: Fecal Microbiota Transplant will be performed.

Label: Dysbiotic bowel syndrome

Type: Experimental

Description: Fecal Microbiota Transplant will be performed.

Label: MRSA enteritis

Type: Experimental

Description: Fecal Microbiota Transplant will be performed.

Label: Pseudomembranous enteritis

Type: Experimental

Description: Fecal Microbiota Transplant will be performed.

Label: Alopecia

Type: Experimental

Description: Fecal Microbiota Transplant will be performed.

Label: Autism

Type: Experimental

Description: Fecal Microbiota Transplant will be performed.

Label: Graft-versus-host disease

Type: Experimental

Description: Fecal Microbiota Transplant will be performed.

Label: Idiopathic thrombocytopenic purpura

Type: Experimental

Description: Fecal Microbiota Transplant will be performed.

Label: Atopy or allergy

Type: Experimental

Description: Fecal Microbiota Transplant will be performed.

Label: Liver disease

Type: Experimental

Description: Fecal Microbiota Transplant will be performed.

Label: Alcohol dependence

Type: Experimental

Description: Fecal Microbiota Transplant will be performed.

Label: Antibiotic-associated diarrhea

Type: Experimental

Description: Fecal Microbiota Transplant will be performed.

Patient Data No
Study Design Info

Allocation: Non-Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov