Efficacy and Safety of Fecal Microbiota Transplantation

Recruiting now · Not applicable

Conditions studied: Fecal Microbiota Transplantation

In brief

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.

Key facts

Study ID

NCT04706611

Run by

Guangzhou First People's Hospital

People needed

300

Starts

2021-01-15

Expected to finish

2026-12-31

Last updated by the study team

2021-04-08

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Guangzhou First People's Hospital — Guangzhou, Guangdong, China (enrolling)

Full record on ClinicalTrials.gov

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