Actively Recruiting

Phase Not Applicable
All Genders
NCT04014413

Safety and Efficacy of Fecal Microbiota Transplantation

Led by Chinese University of Hong Kong · Updated on 2024-08-22

450

Participants Needed

1

Research Sites

589 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Safety and Efficacy of Fecal Microbiota Transplantation

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Confirmed diagnosis of Crohn's disease
  • Confirmed diagnosis of ulcerative colitis
  • Confirmed diagnosis of celiac disease
  • Confirmed diagnosis of irritable bowel syndrome
  • Confirmed diagnosis of functional dyspepsia
  • Confirmed diagnosis of constipation
  • Antibiotic-associated diarrhea or 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 or 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 with suboptimal disease control despite standard treatment
Not Eligible

You will not qualify if you...

  • Known contraindication to all FMT infusion methods such as nasoduodenal tube insertion, oesophago-gastro-duodenoscopy (OGD), enteroscopy, colonoscopy, and enema
  • Any condition that may affect the efficacy of FMT or as determined by investigators
  • Current pregnancy

AI-Screening

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Trial Site Locations

Total: 1 location

1

The Chinese University of Hong Kong

Hong Kong, Shatin, Hong Kong, 000000

Actively Recruiting

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Research Team

M

Matthew Fung

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

25

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