Efficacy and Safety of Fecal Microbiota Transplantation
Efficacy and Safety of Fecal Microbiota Transplantation in Patients With Intestinal Dysbiosis -A Pilot Study
Guangzhou First People's Hospital
300 participants
Jan 15, 2021
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria44
- 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 Criteria4
- 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.
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Interventions
Procedure: Fecal Microbiota Transplantation
Locations(1)
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NCT04706611