Safety and Efficacy of Fecal Microbiota Transplantation

Last updated: August 21, 2024
Sponsor: Chinese University of Hong Kong
Overall Status: Active - Recruiting

Phase

N/A

Condition

Alcohol Dependence

Autism

Celiac Disease

Treatment

Fecal Microbiota Transplantation

Clinical Study ID

NCT04014413
FMT-Pilot
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 Nonalcoholicsteatohepatitis (NASH)

  • Alcohol dependence

  • Psoriatic arthropathy that has suboptimal control of disease despite standardtreatment.

Exclusion

Exclusion Criteria:

  • Known contraindication to all FMT infusion method such as nasoduodenal tubeinsertion, oesophago-gastro-duodenoscopy (OGD), enteroscopy, colonoscopy and enema

  • Any conditions that may render the efficacy of FMT or at the discretion of theinvestigators

  • Current pregnancy

Study Design

Total Participants: 450
Treatment Group(s): 1
Primary Treatment: Fecal Microbiota Transplantation
Phase:
Study Start date:
July 15, 2019
Estimated Completion Date:
October 31, 2030

Connect with a study center

  • The Chinese University of Hong Kong

    Hong Kong, Shatin 000000
    Hong Kong

    Active - Recruiting

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