Safety and Efficacy of Fecal Microbiota Transplantation

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages N/A and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04014413
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Chinese University of Hong Kong
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Siew Ng
Principal Investigator Affiliation Chinese University of Hong Kong
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Hong Kong
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

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
Arms & Interventions

Arms

Experimental: Crohn's disease

Fecal Microbiota Transplant will be performed.

Experimental: Ulcerative colitis

Fecal Microbiota Transplant will be performed.

Experimental: Celiac disease

Fecal Microbiota Transplant will be performed.

Experimental: Irritable bowel syndrome

Fecal Microbiota Transplant will be performed.

Experimental: Functional dyspepsia

Fecal Microbiota Transplant will be performed.

Experimental: Constipation

Fecal Microbiota Transplant will be performed.

Experimental: Metabolic disease (diabetes mellitus or obesity)

Fecal Microbiota Transplant will be performed.

Experimental: Multidrug-resistant infection

Fecal Microbiota Transplant will be performed.

Experimental: Hepatic encephalopathy

Fecal Microbiota Transplant will be performed.

Experimental: Multiple sclerosis

Fecal Microbiota Transplant will be performed.

Experimental: Pseudo-obstruction

Fecal Microbiota Transplant will be performed.

Experimental: CRE infection

Fecal Microbiota Transplant will be performed.

Experimental: VRE infection

Fecal Microbiota Transplant will be performed.

Experimental: Multiple organ dysfunction

Fecal Microbiota Transplant will be performed.

Experimental: Dysbiotic bowel syndrome

Fecal Microbiota Transplant will be performed.

Experimental: MRSA enteritis

Fecal Microbiota Transplant will be performed.

Experimental: Pseudomembranous enteritis

Fecal Microbiota Transplant will be performed.

Experimental: Alopecia

Fecal Microbiota Transplant will be performed.

Experimental: Autism

Fecal Microbiota Transplant will be performed.

Experimental: Graft-versus-host disease

Fecal Microbiota Transplant will be performed.

Experimental: Idiopathic thrombocytopenic purpura

Fecal Microbiota Transplant will be performed.

Experimental: Atopy or allergy

Fecal Microbiota Transplant will be performed.

Experimental: Liver disease

Fecal Microbiota Transplant will be performed.

Experimental: Alcohol dependence

Fecal Microbiota Transplant will be performed.

Experimental: Antibiotic-associated diarrhea

Fecal Microbiota Transplant will be performed.

Interventions

Procedure: - Fecal Microbiota Transplantation

Fecal microbiota transplantation

Contact a Trial Team

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International Sites

The Chinese University of Hong Kong, Hong Kong, Shatin, Hong Kong

Status

Recruiting

Address

The Chinese University of Hong Kong

Hong Kong, Shatin, 000000

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