Efficacy and Safety of Fecal Microbiota Transplantation

  • STATUS
    Recruiting
  • End date
    Dec 31, 2026
  • participants needed
    300
  • sponsor
    Guangzhou First People's Hospital
Updated on 19 April 2021

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.

Details
Condition Fecal Microbiota Transplantation
Treatment Fecal Microbiota Transplantation
Clinical Study IdentifierNCT04706611
SponsorGuangzhou First People's Hospital
Last Modified on19 April 2021

Eligibility

Yes No Not Sure

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
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