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Tests fecal microbiota transplantation in people with gut-related conditions

Tests stool transfer from healthy donors in people with gut-related conditions.

Key facts

Who runs it
Chinese University of Hong Kong
Where
Hong Kong, Hong KongSee the site
Trial code
Registry title
Safety and Efficacy of Fecal Microbiota Transplantation
Status
Recruiting
People taking part
450 people, planned
Started
15 Jul 2019
Expected to end
31 Oct 2030
Type of study
Interventional, 25 groups
Treatments tested
  • Fecal Microbiota Transplantation
Record updated
22 August 2024

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for people with a confirmed diagnosis of one of many gut-related or dysbiosis-linked conditions, such as Crohn's disease, ulcerative colitis or constipation. It tests fecal microbiota transplantation.

Sex
All sexes can join.
Disease stage
A confirmed diagnosis of one of the listed diseases, for example Crohn's disease, ulcerative colitis, celiac disease, irritable bowel syndrome, constipation, diabetes mellitus, obesity or multidrug-resistant infection. Psoriatic arthropathy can count if it is not well controlled despite standard treatment.
Earlier treatment
For psoriatic arthropathy, disease control must be suboptimal despite standard treatment. Nothing else is stated.

Main reasons for not taking part

  • Known contraindication to all methods of giving FMT (such as nasoduodenal tube, OGD, enteroscopy, colonoscopy, enema)
  • Any condition that may affect how well FMT works, or at the investigators' discretion
  • Current pregnancy

The registry criteria, word for word

Show all 28 criteriaShow less

Who can take part

  • 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

Who cannot take part

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

Where in Hong Kong

  • The Chinese University of Hong KongHong Kong, Hong KongContact: Matthew FungTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 25 groups in the trial

  • Crohn's diseaseTreatment being tested

    Fecal Microbiota Transplant will be performed.

    Treatment: Fecal Microbiota Transplantation

  • Ulcerative colitisTreatment being tested

    Fecal Microbiota Transplant will be performed.

    Treatment: Fecal Microbiota Transplantation

  • Celiac diseaseTreatment being tested

    Fecal Microbiota Transplant will be performed.

    Treatment: Fecal Microbiota Transplantation

  • Irritable bowel syndromeTreatment being tested

    Fecal Microbiota Transplant will be performed.

    Treatment: Fecal Microbiota Transplantation

  • Functional dyspepsiaTreatment being tested

    Fecal Microbiota Transplant will be performed.

    Treatment: Fecal Microbiota Transplantation

  • ConstipationTreatment being tested

    Fecal Microbiota Transplant will be performed.

    Treatment: Fecal Microbiota Transplantation

  • Metabolic disease (diabetes mellitus or obesity)Treatment being tested

    Fecal Microbiota Transplant will be performed.

    Treatment: Fecal Microbiota Transplantation

  • Multidrug-resistant infectionTreatment being tested

    Fecal Microbiota Transplant will be performed.

    Treatment: Fecal Microbiota Transplantation

  • Hepatic encephalopathyTreatment being tested

    Fecal Microbiota Transplant will be performed.

    Treatment: Fecal Microbiota Transplantation

  • Multiple sclerosisTreatment being tested

    Fecal Microbiota Transplant will be performed.

    Treatment: Fecal Microbiota Transplantation

  • Pseudo-obstructionTreatment being tested

    Fecal Microbiota Transplant will be performed.

    Treatment: Fecal Microbiota Transplantation

  • CRE infectionTreatment being tested

    Fecal Microbiota Transplant will be performed.

    Treatment: Fecal Microbiota Transplantation

  • VRE infectionTreatment being tested

    Fecal Microbiota Transplant will be performed.

    Treatment: Fecal Microbiota Transplantation

  • Multiple organ dysfunctionTreatment being tested

    Fecal Microbiota Transplant will be performed.

    Treatment: Fecal Microbiota Transplantation

  • Dysbiotic bowel syndromeTreatment being tested

    Fecal Microbiota Transplant will be performed.

    Treatment: Fecal Microbiota Transplantation

  • MRSA enteritisTreatment being tested

    Fecal Microbiota Transplant will be performed.

    Treatment: Fecal Microbiota Transplantation

  • Pseudomembranous enteritisTreatment being tested

    Fecal Microbiota Transplant will be performed.

    Treatment: Fecal Microbiota Transplantation

  • AlopeciaTreatment being tested

    Fecal Microbiota Transplant will be performed.

    Treatment: Fecal Microbiota Transplantation

  • AutismTreatment being tested

    Fecal Microbiota Transplant will be performed.

    Treatment: Fecal Microbiota Transplantation

  • Graft-versus-host diseaseTreatment being tested

    Fecal Microbiota Transplant will be performed.

    Treatment: Fecal Microbiota Transplantation

  • Idiopathic thrombocytopenic purpuraTreatment being tested

    Fecal Microbiota Transplant will be performed.

    Treatment: Fecal Microbiota Transplantation

  • Atopy or allergyTreatment being tested

    Fecal Microbiota Transplant will be performed.

    Treatment: Fecal Microbiota Transplantation

  • Liver diseaseTreatment being tested

    Fecal Microbiota Transplant will be performed.

    Treatment: Fecal Microbiota Transplantation

  • Alcohol dependenceTreatment being tested

    Fecal Microbiota Transplant will be performed.

    Treatment: Fecal Microbiota Transplantation

  • Antibiotic-associated diarrheaTreatment being tested

    Fecal Microbiota Transplant will be performed.

    Treatment: Fecal Microbiota Transplantation

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Safety and Efficacy of Fecal Microbiota Transplantation: A Pilot Study
Plain-language title
Tests fecal microbiota transplantation in people with gut-related conditionsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
22 August 2024