Safety and Efficacy of Fecal Microbiota Transplantation

Study Overview
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Brief Summary
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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.

Official Title
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Safety and Efficacy of Fecal Microbiota Transplantation: A Pilot Study

Conditions
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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

Intervention / Treatment
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* Procedure: Fecal Microbiota Transplantation


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0 |  | 1 year |