Efficacy and Safety of Fecal Microbiota Transplantation

Study Overview
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Brief Summary
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In recent years, researches illustrate that multifactorial diseases such as functional gastrointestinal disorders, autoimmune diseases, metabolic, behavioral and neurological diseases are associated with an abnormal microbiome structure-dysbiosis, which means the imbalance of the microbiome community. Fecal microbiota transplantation (FMT), the infusion of faeces from a healthy donor to the gastrointestinal tract of a recipient patient aiming to alter the intestine microbiota, is recommended to be performed in Clostridium difficile infection(CDI) as the most effective therapy. It also being used experimentally in the treatment of the disease states linked to dysbiosis of the intestinal microbiota. However, the efficacy and safety of FMT to treat the dysbiosis-associated diseases is still in its infancy. To further verify the indications above, more data is required to be collected through studies.

Official Title
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Efficacy and Safety of Fecal Microbiota Transplantation in Patients With Intestinal Dysbiosis -A Pilot Study

Conditions
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Fecal Microbiota Transplantation

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 following diseases: Irritable Bowel Syndrome Ulcerative colitis Crohn's disease Constipation Clostridium Difficile Infection Functional Dyspepsia Parkinson's Disease Metabolic Syndrome Non-Alcoholic Fatty Liver Disease Autism Spectrum Disorder Radiation Enteritis Atopic Dermatitis Food Allergic Graft-versus-Host Disease Obesity Diabetes mellitus Multi-Drug Resistant Infection Hepatic Encephalopathy Enteric Dysbacteriosis Multiple Sclerosis Pseudomembranous Enteritis Acute Pancreatitis Chronic Fatigue Syndrome Acute-on-chronic Liver Failure with HBV Infection Alcoholic Liver Disease Anorexia Decompensated Cirrhosis Henoch-Schonlein Purpura Autoimmune Liver Disease Systemic Lupus Erythematosus Rheumatoid arthritis IgG4-Related Disease Celiac Disease Protein-losing Enteropathy Asperger Syndrome Rheumatoid arthritis Psoriasis Ankylosing spondylitis Immune checkpoint inhibition-related colitis Autoimmune enteropathy Drug-induced diarrhea Suffering from gastrointestinal symptoms such as constipation, diarrheas, abdominal pain, flatulence, etc. The participants must be able to tolerate the FMT infusion method such as endoscopy, colonoscopy, capsule, nasoduodenal tube insertion, etc. Exclusion Criteria: Current pregnancy or breast-feeding; Suffering from other severe diseases, including liver or kidney failure, heart failure, MODS, coma, cerebrovascular accident; Known contraindication to all FMT infusion method such as nasoduodenal tube insertion, endoscopy, colonoscopy and enema; Any conditions that may render the efficacy of FMT or at the discretion of the investigators.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

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: Irritable Bowel Syndrome<br>Fecal Microbiota Transplantation will be performed. | Procedure: Fecal Microbiota Transplantation<br>* Procedure: Fecal Microbiota Transplantation<br>|
| Experimental: Constipation<br>Fecal Microbiota Transplantation will be performed. | Procedure: Fecal Microbiota Transplantation<br>* Procedure: Fecal Microbiota Transplantation<br>|
| Experimental: Clostridium Difficile Infection<br>Fecal Microbiota Transplantation will be performed. | Procedure: Fecal Microbiota Transplantation<br>* Procedure: Fecal Microbiota Transplantation<br>|
| Experimental: Functional Dyspepsia<br>Fecal Microbiota Transplantation will be performed. | Procedure: Fecal Microbiota Transplantation<br>* Procedure: Fecal Microbiota Transplantation<br>|
| Experimental: Parkinson's Disease<br>Fecal Microbiota Transplantation will be performed. | Procedure: Fecal Microbiota Transplantation<br>* Procedure: Fecal Microbiota Transplantation<br>|
| Experimental: Metabolic Syndrome<br>Fecal Microbiota Transplantation will be performed. | Procedure: Fecal Microbiota Transplantation<br>* Procedure: Fecal Microbiota Transplantation<br>|
| Experimental: Non-Alcoholic Fatty Liver Disease<br>Fecal Microbiota Transplantation will be performed. | Procedure: Fecal Microbiota Transplantation<br>* Procedure: Fecal Microbiota Transplantation<br>|
| Experimental: Autism Spectrum Disorder<br>Fecal Microbiota Transplantation will be performed. | Procedure: Fecal Microbiota Transplantation<br>* Procedure: Fecal Microbiota Transplantation<br>|
| Experimental: Radiation Enteritis<br>Fecal Microbiota Transplantation will be performed. | Procedure: Fecal Microbiota Transplantation<br>* Procedure: Fecal Microbiota Transplantation<br>|
| Experimental: Atopic Dermatitis<br>Fecal Microbiota Transplantation will be performed. | Procedure: Fecal Microbiota Transplantation<br>* Procedure: Fecal Microbiota Transplantation<br>|
| Experimental: Food Allergic<br>Fecal Microbiota Transplantation will be performed. | Procedure: Fecal Microbiota Transplantation<br>* Procedure: Fecal Microbiota Transplantation<br>|
| Experimental: Graft-versus-Host Disease<br>Fecal Microbiota Transplantation will be performed. | Procedure: Fecal Microbiota Transplantation<br>* Procedure: Fecal Microbiota Transplantation<br>|
| Experimental: Obesity<br>Fecal Microbiota Transplantation will be performed. | Procedure: Fecal Microbiota Transplantation<br>* Procedure: Fecal Microbiota Transplantation<br>|
| Experimental: Diabetes mellitus<br>Fecal Microbiota Transplantation will be performed. | Procedure: Fecal Microbiota Transplantation<br>* Procedure: Fecal Microbiota Transplantation<br>|
| Experimental: Multi-Drug Resistant Infection<br>Fecal Microbiota Transplantation will be performed. | Procedure: Fecal Microbiota Transplantation<br>* Procedure: Fecal Microbiota Transplantation<br>|
| Experimental: Hepatic Encephalopathy<br>Fecal Microbiota Transplantation will be performed. | Procedure: Fecal Microbiota Transplantation<br>* Procedure: Fecal Microbiota Transplantation<br>|
| Experimental: Enteric Dysbacteriosis<br>Fecal Microbiota Transplantation will be performed. | Procedure: Fecal Microbiota Transplantation<br>* Procedure: Fecal Microbiota Transplantation<br>|
| Experimental: Multiple Sclerosis<br>Fecal Microbiota Transplantation will be performed. | Procedure: Fecal Microbiota Transplantation<br>* Procedure: Fecal Microbiota Transplantation<br>|
| Experimental: Pseudomembranous Enteritis<br>Fecal Microbiota Transplantation will be performed. | Procedure: Fecal Microbiota Transplantation<br>* Procedure: Fecal Microbiota Transplantation<br>|
| Experimental: Acute Pancreatitis<br>Fecal Microbiota Transplantation will be performed. | Procedure: Fecal Microbiota Transplantation<br>* Procedure: Fecal Microbiota Transplantation<br>|
| Experimental: Chronic Fatigue Syndrome<br>Fecal Microbiota Transplantation will be performed. | Procedure: Fecal Microbiota Transplantation<br>* Procedure: Fecal Microbiota Transplantation<br>|
| Experimental: Acute-on-chronic Liver Failure with HBV Infection<br>Fecal Microbiota Transplantation will be performed. | Procedure: Fecal Microbiota Transplantation<br>* Procedure: Fecal Microbiota Transplantation<br>|
| Experimental: Alcoholic Liver Disease<br>Fecal Microbiota Transplantation will be performed. | Procedure: Fecal Microbiota Transplantation<br>* Procedure: Fecal Microbiota Transplantation<br>|
| Experimental: Anorexia<br>Fecal Microbiota Transplantation will be performed. | Procedure: Fecal Microbiota Transplantation<br>* Procedure: Fecal Microbiota Transplantation<br>|
| Experimental: Decompensated Cirrhosis<br>Fecal Microbiota Transplantation will be performed. | Procedure: Fecal Microbiota Transplantation<br>* Procedure: Fecal Microbiota Transplantation<br>|
| Experimental: Henoch-Schonlein Purpura<br>Fecal Microbiota Transplantation will be performed. | Procedure: Fecal Microbiota Transplantation<br>* Procedure: Fecal Microbiota Transplantation<br>|
| Experimental: Autoimmune Liver Disease<br>Fecal Microbiota Transplantation will be performed. | Procedure: Fecal Microbiota Transplantation<br>* Procedure: Fecal Microbiota Transplantation<br>|
| Experimental: Systemic Lupus Erythematosus<br>Fecal Microbiota Transplantation will be performed. | Procedure: Fecal Microbiota Transplantation<br>* Procedure: Fecal Microbiota Transplantation<br>|
| Experimental: IgG4-Related Disease<br>Fecal Microbiota Transplantation will be performed. | Procedure: Fecal Microbiota Transplantation<br>* Procedure: Fecal Microbiota Transplantation<br>|
| Experimental: Celiac Disease<br>Fecal Microbiota Transplantation will be performed. | Procedure: Fecal Microbiota Transplantation<br>* Procedure: Fecal Microbiota Transplantation<br>|
| Experimental: Protein-losing Enteropathy<br>Fecal Microbiota Transplantation will be performed. | Procedure: Fecal Microbiota Transplantation<br>* Procedure: Fecal Microbiota Transplantation<br>|
| Experimental: Asperger Syndrome<br>Fecal Microbiota Transplantation will be performed. | Procedure: Fecal Microbiota Transplantation<br>* Procedure: Fecal Microbiota Transplantation<br>|
| Experimental: Rheumatoid arthritis<br>Fecal Microbiota Transplantation will be performed. | Procedure: Fecal Microbiota Transplantation<br>* Procedure: Fecal Microbiota Transplantation<br>|
| Experimental: Ulcerative colitis<br>Fecal Microbiota Transplantation will be performed. | Procedure: Fecal Microbiota Transplantation<br>* Procedure: Fecal Microbiota Transplantation<br>|
| Experimental: Crohn's disease<br>Fecal Microbiota Transplantation will be performed. | Procedure: Fecal Microbiota Transplantation<br>* Procedure: Fecal Microbiota Transplantation<br>|
| Experimental: Psoriasis<br>Fecal Microbiota Transplantation will be performed. | Procedure: Fecal Microbiota Transplantation<br>* Procedure: Fecal Microbiota Transplantation<br>|
| Experimental: Ankylosing spondylitis<br>Fecal Microbiota Transplantation will be performed. | Procedure: Fecal Microbiota Transplantation<br>* Procedure: Fecal Microbiota Transplantation<br>|
| Experimental: Immune checkpoint inhibition-related colitis<br>Fecal Microbiota Transplantation will be performed. | Procedure: Fecal Microbiota Transplantation<br>* Procedure: Fecal Microbiota Transplantation<br>|
| Experimental: Autoimmune enteropathy<br>Fecal Microbiota Transplantation will be performed. | Procedure: Fecal Microbiota Transplantation<br>* Procedure: Fecal Microbiota Transplantation<br>|
| Experimental: Drug-induced diarrhea<br>Fecal Microbiota Transplantation will be performed. | Procedure: Fecal Microbiota Transplantation<br>* Procedure: 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 patients with gastrointestinal symptom will be assessed by the change of Gastrointestinal Symptom Rating Scale(GSRS). | Gastrointestinal Symptom Rating Scale(GSRS) is a measure of gastrointestinal symptom severity in five clusters (pain, bloating, constipation, diarrhea, and early satiety).The items are scored between 1 and 7, where 1 corresponds to no discomfort at all and 7 to very severe discomfort from the symptom. The participants will be asked to filled in the scale in several time points from baseline to 12 months after FMT. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Treatment-Related Adverse Events as Assessed by Common Terminology Criteria for Adverse Events(CTCAE) V4.0 |  | 1 year |