Efficacy and Safety of Fecal Microbiota Transplantation
Not Applicable
Recruiting
- Conditions
- Fecal Microbiota Transplantation
- Interventions
- Procedure: Fecal Microbiota Transplantation
- Registration Number
- NCT04706611
- Lead Sponsor
- Guangzhou First People's Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 300
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Acute Pancreatitis Fecal Microbiota Transplantation Fecal Microbiota Transplantation will be performed. Clostridium Difficile Infection Fecal Microbiota Transplantation Fecal Microbiota Transplantation will be performed. Functional Dyspepsia Fecal Microbiota Transplantation Fecal Microbiota Transplantation will be performed. Constipation Fecal Microbiota Transplantation Fecal Microbiota Transplantation will be performed. Atopic Dermatitis Fecal Microbiota Transplantation Fecal Microbiota Transplantation will be performed. Food Allergic Fecal Microbiota Transplantation Fecal Microbiota Transplantation will be performed. Obesity Fecal Microbiota Transplantation Fecal Microbiota Transplantation will be performed. Diabetes mellitus Fecal Microbiota Transplantation Fecal Microbiota Transplantation will be performed. Multi-Drug Resistant Infection Fecal Microbiota Transplantation Fecal Microbiota Transplantation will be performed. Autoimmune Liver Disease Fecal Microbiota Transplantation Fecal Microbiota Transplantation will be performed. Asperger Syndrome Fecal Microbiota Transplantation Fecal Microbiota Transplantation will be performed. Ulcerative colitis Fecal Microbiota Transplantation Fecal Microbiota Transplantation will be performed. Ankylosing spondylitis Fecal Microbiota Transplantation Fecal Microbiota Transplantation will be performed. Autoimmune enteropathy Fecal Microbiota Transplantation Fecal Microbiota Transplantation will be performed. Parkinson's Disease Fecal Microbiota Transplantation Fecal Microbiota Transplantation will be performed. Irritable Bowel Syndrome Fecal Microbiota Transplantation Fecal Microbiota Transplantation will be performed. Metabolic Syndrome Fecal Microbiota Transplantation Fecal Microbiota Transplantation will be performed. Graft-versus-Host Disease Fecal Microbiota Transplantation Fecal Microbiota Transplantation will be performed. Hepatic Encephalopathy Fecal Microbiota Transplantation Fecal Microbiota Transplantation will be performed. Enteric Dysbacteriosis Fecal Microbiota Transplantation Fecal Microbiota Transplantation will be performed. Henoch-Schonlein Purpura Fecal Microbiota Transplantation Fecal Microbiota Transplantation will be performed. IgG4-Related Disease Fecal Microbiota Transplantation Fecal Microbiota Transplantation will be performed. Non-Alcoholic Fatty Liver Disease Fecal Microbiota Transplantation Fecal Microbiota Transplantation will be performed. Radiation Enteritis Fecal Microbiota Transplantation Fecal Microbiota Transplantation will be performed. Multiple Sclerosis Fecal Microbiota Transplantation Fecal Microbiota Transplantation will be performed. Acute-on-chronic Liver Failure with HBV Infection Fecal Microbiota Transplantation Fecal Microbiota Transplantation will be performed. Alcoholic Liver Disease Fecal Microbiota Transplantation Fecal Microbiota Transplantation will be performed. Anorexia Fecal Microbiota Transplantation Fecal Microbiota Transplantation will be performed. Celiac Disease Fecal Microbiota Transplantation Fecal Microbiota Transplantation will be performed. Rheumatoid arthritis Fecal Microbiota Transplantation Fecal Microbiota Transplantation will be performed. Drug-induced diarrhea Fecal Microbiota Transplantation Fecal Microbiota Transplantation will be performed. Autism Spectrum Disorder Fecal Microbiota Transplantation Fecal Microbiota Transplantation will be performed. Pseudomembranous Enteritis Fecal Microbiota Transplantation Fecal Microbiota Transplantation will be performed. Chronic Fatigue Syndrome Fecal Microbiota Transplantation Fecal Microbiota Transplantation will be performed. Decompensated Cirrhosis Fecal Microbiota Transplantation Fecal Microbiota Transplantation will be performed. Protein-losing Enteropathy Fecal Microbiota Transplantation Fecal Microbiota Transplantation will be performed. Psoriasis Fecal Microbiota Transplantation Fecal Microbiota Transplantation will be performed. Immune checkpoint inhibition-related colitis Fecal Microbiota Transplantation Fecal Microbiota Transplantation will be performed. Systemic Lupus Erythematosus Fecal Microbiota Transplantation Fecal Microbiota Transplantation will be performed. Crohn's disease Fecal Microbiota Transplantation Fecal Microbiota Transplantation will be performed.
- Primary Outcome Measures
Name Time Method The efficacy of FMT in patients with gastrointestinal symptom will be assessed by the change of Gastrointestinal Symptom Rating Scale(GSRS). 1 year 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.
- Secondary Outcome Measures
Name Time Method Number of Participants With Treatment-Related Adverse Events as Assessed by Common Terminology Criteria for Adverse Events(CTCAE) V4.0 1 year
Trial Locations
- Locations (1)
Guangzhou First People's Hospital
🇨🇳Guangzhou, Guangdong, China