Safety and Efficacy of Fecal Microbiota Transplantation

  • STATUS
    Recruiting
  • End date
    Oct 31, 2024
  • participants needed
    450
  • sponsor
    Chinese University of Hong Kong
Updated on 23 March 2022
diabetes
constipation
antibiotic therapy
antibiotics
carbapenem
metabolic syndrome
irritable bowel syndrome
diarrhea
diabetes mellitus
vancomycin
hepatitis
encephalopathy
liver disease
microbiota
obstruction
ulcerative colitis
fatty liver
antibiotic
graft-versus-host disease
alopecia
alcoholism
alcoholic hepatitis
dysbiosis
atopy
crohn's disease
fecal microbiota transplantation
colitis
autism
MRSA
purpura
ulceration
celiac disease
disease or disorder
multiple sclerosis
hepatic encephalopathy
disease idiopathic
resistant infection
pouchitis

Summary

The gut microbiota is critical to health and functions with a level of complexity comparable to that of an organ system. Dysbiosis, or alterations of this gut microbiota ecology, have been implicated in a number of disease states. Fecal microbiota transplantation (FMT), defined as infusion of feces from healthy donors to affected subjects, is a method to restore a balanced gut microbiota and has attracted great interest in recent years due to its efficacy and ease of use. FMT is now recommended as the most effective therapy for CDI not responding to standard therapies.

Recent studies have suggested that dysbiosis is associated with a variety of disorders, and that FMT could be a useful treatment. Randomized controlled trial has been conducted in a number of disorders and shown positive results, including alcoholic hepatitis, Crohn's disease (CD), ulcerative colitis (UC), pouchitis, irritable bowel syndrome (IBS), hepatic encephalopathy and metabolic syndrome. Case series/reports and pilot studies has shown positive results in other disorders including Celiac disease, functional dyspepsia, constipation, metabolic syndrome such as diabetes mellitus, multidrug-resistant, hepatic encephalopathy, multiple sclerosis, pseudo-obstruction, carbapenem-resistant Enterobacteriaceae (CRE) or Vancomycin-resistant Enterococci (VRE) infection, radiation-induced toxicity, multiple organ dysfunction, dysbiotic bowel syndrome, MRSA enteritis, Pseudomembranous enteritis, idiopathic thrombocytopenic purpura (ITP), and atopy.

Despite FMT appears to be relatively safe and efficacious in treating a wide range of disease, its safety and efficacy in a usual clinical setting is unknown. More data is required to confirm safety and efficacy of FMT. Therefore, the investigators aim to conduct a pilot study to investigate the efficacy and safety of FMT in a variety of dysbiosis-associated disorder.

Details
Condition Crohn Disease, Ulcerative Colitis, Celiac Disease, Irritable Bowel Syndrome, Functional Dysphonia, Constipation, Clostridium Difficile Infection, Diabetes Mellitus, Obesity, Multidrug -Resistant Infection, Hepatic Encephalopathy, Multiple Sclerosis, Pseudo-Obstruction, Carbapenem-Resistant Enterobacteriaceae Infection, Vancomycin Resistant Enterococci Infection, Multiple Organ Dysfunction Syndrome, Dysbiotic Bowel Syndrome, MRSA Enteritis, Pseudomembranous Enterocolitis, Alopecia, Autism, Graft-versus-host Disease, Idiopathic Thrombocytopenic Purpura, Atopy or Allergy, Liver Disease, Alcohol Dependence, Psoriatic Arthropathy
Treatment Fecal Microbiota Transplantation
Clinical Study IdentifierNCT04014413
SponsorChinese University of Hong Kong
Last Modified on23 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Confirmed diagnosis of any of the following diseases
Crohn's disease
Ulcerative colitis
Celiac disease
Irritable bowel syndrome
Functional dyspepsia
Constipation
Antibiotic-associated diarrhea or any antibiotic- associated complications/symptoms
Metabolic syndrome such as diabetes mellitus and obesity
Multidrug-resistant infection
Hepatic encephalopathy
Multiple sclerosis
Pseudo-obstruction
Carbapenem-resistant Enterobacteriaceae (CRE) or Vancomycin-resistant Enterococci (VRE) infection
Multiple organ dysfunction
Dysbiotic bowel syndrome
MRSA enteritis
Pseudomembranous enteritis
Alopecia, autism
Graft-versus-host disease
Idiopathic thrombocytopenic purpura (ITP)
Atopy or allergy
Liver disease such as Nonalcoholic fatty liver disease (NAFLD) and Nonalcoholic steatohepatitis (NASH)
Alcohol dependence
Psoriatic arthropathy that has suboptimal control of disease despite standard treatment

Exclusion Criteria

Known contraindication to all FMT infusion method such as nasoduodenal tube insertion, oesophago-gastro-duodenoscopy (OGD), enteroscopy, colonoscopy and enema
Any conditions that may render the efficacy of FMT or at the discretion of the investigators
Current pregnancy
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