Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
NCT04706611

Efficacy and Safety of Fecal Microbiota Transplantation

Led by Guangzhou First People's Hospital · Updated on 2021-04-08

300

Participants Needed

1

Research Sites

310 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Efficacy and Safety of Fecal Microbiota Transplantation

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Confirmed diagnosis of one or more of the 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 Allergy, 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, 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.
  • Able to tolerate FMT infusion methods such as endoscopy, colonoscopy, capsule, nasoduodenal tube insertion, etc.
Not Eligible

You will not qualify if you...

  • Currently pregnant or breastfeeding
  • Suffering from other severe diseases including liver or kidney failure, heart failure, multiple organ dysfunction syndrome (MODS), coma, or cerebrovascular accident
  • Known contraindications to all FMT infusion methods such as nasoduodenal tube insertion, endoscopy, colonoscopy, and enema
  • Any conditions that may reduce the efficacy of FMT or as determined by the investigators

AI-Screening

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Trial Site Locations

Total: 1 location

1

Guangzhou First People's Hospital

Guangzhou, Guangdong, China, 510180

Actively Recruiting

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Research Team

Y

Yongjian Zhou, MM

CONTACT

H

Hongli Huang, MM

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

40

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