Safety and Efficacy of Fecal Microbiota Transplantation: A Pilot Study
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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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Crohn's disease | Experimental | Procedure: Fecal Microbiota Transplantation | Fecal Microbiota Transplant will be performed. |
| Ulcerative colitis | Experimental | Procedure: Fecal Microbiota Transplantation | Fecal Microbiota Transplant will be performed. |
| Celiac disease | Experimental | Procedure: Fecal Microbiota Transplantation | Fecal Microbiota Transplant will be performed. |
| Irritable bowel syndrome | Experimental | Procedure: Fecal Microbiota Transplantation | Fecal Microbiota Transplant will be performed. |
| Functional dyspepsia | Experimental | Procedure: Fecal Microbiota Transplantation | Fecal Microbiota Transplant will be performed. |
| Constipation | Experimental | Procedure: Fecal Microbiota Transplantation | Fecal Microbiota Transplant will be performed. |
| Metabolic disease (diabetes mellitus or obesity) | Experimental | Procedure: Fecal Microbiota Transplantation | Fecal Microbiota Transplant will be performed. |
| Multidrug-resistant infection | Experimental | Procedure: Fecal Microbiota Transplantation | Fecal Microbiota Transplant will be performed. |
| Hepatic encephalopathy | Experimental | Procedure: Fecal Microbiota Transplantation | Fecal Microbiota Transplant will be performed. |
| Multiple sclerosis | Experimental | Procedure: Fecal Microbiota Transplantation | Fecal Microbiota Transplant will be performed. |
| Pseudo-obstruction | Experimental | Procedure: Fecal Microbiota Transplantation | Fecal Microbiota Transplant will be performed. |
| CRE infection | Experimental | Procedure: Fecal Microbiota Transplantation | Fecal Microbiota Transplant will be performed. |
| VRE infection | Experimental | Procedure: Fecal Microbiota Transplantation | Fecal Microbiota Transplant will be performed. |
| Multiple organ dysfunction | Experimental | Procedure: Fecal Microbiota Transplantation | Fecal Microbiota Transplant will be performed. |
| Dysbiotic bowel syndrome | Experimental | Procedure: Fecal Microbiota Transplantation | Fecal Microbiota Transplant will be performed. |
| MRSA enteritis | Experimental | Procedure: Fecal Microbiota Transplantation | Fecal Microbiota Transplant will be performed. |
| Pseudomembranous enteritis | Experimental | Procedure: Fecal Microbiota Transplantation | Fecal Microbiota Transplant will be performed. |
| Alopecia | Experimental | Procedure: Fecal Microbiota Transplantation | Fecal Microbiota Transplant will be performed. |
| Autism | Experimental | Procedure: Fecal Microbiota Transplantation | Fecal Microbiota Transplant will be performed. |
| Graft-versus-host disease | Experimental | Procedure: Fecal Microbiota Transplantation | Fecal Microbiota Transplant will be performed. |
| Idiopathic thrombocytopenic purpura | Experimental | Procedure: Fecal Microbiota Transplantation | Fecal Microbiota Transplant will be performed. |
| Atopy or allergy | Experimental | Procedure: Fecal Microbiota Transplantation | Fecal Microbiota Transplant will be performed. |
| Liver disease | Experimental | Procedure: Fecal Microbiota Transplantation | Fecal Microbiota Transplant will be performed. |
| Alcohol dependence | Experimental | Procedure: Fecal Microbiota Transplantation | Fecal Microbiota Transplant will be performed. |
| Antibiotic-associated diarrhea | Experimental | Procedure: Fecal Microbiota Transplantation | Fecal Microbiota Transplant will be performed. |
Sex: All
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
| Facility | City | Country | Status |
|---|---|---|---|
| The Chinese University of Hong Kong | Hong Kong, Shatin | Hong Kong | Recruiting |