Safety and Efficacy of Fecal Microbiota Transplantation

Sponsor
Chinese University of Hong Kong
Study ID
NCT04014413
Status
Recruiting
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Conditions

  • Alcohol Dependence
  • Alopecia
  • Atopy or Allergy
  • Autism
  • Carbapenem-Resistant Enterobacteriaceae Infection
  • Celiac Disease
  • Clostridium Difficile Infection
  • Constipation
  • Crohn Disease
  • Diabetes Mellitus
  • Dysbiotic Bowel Syndrome
  • Functional Dysphonia
  • Graft-versus-host Disease
  • Hepatic Encephalopathy
  • Idiopathic Thrombocytopenic Purpura
  • Irritable Bowel Syndrome
  • Liver Disease
  • MRSA Enteritis
  • Multidrug -Resistant Infection
  • Multiple Organ Dysfunction Syndrome
  • Multiple Sclerosis
  • Obesity
  • Pseudo-Obstruction
  • Pseudomembranous Enterocolitis
  • Psoriatic Arthropathy
  • Ulcerative Colitis
  • Vancomycin Resistant Enterococci Infection

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Fecal Microbiota Transplantation — PROCEDURE
    Fecal microbiota transplantation

Study Details

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.

Key Dates

First listed
Jul 10, 2019
Start date
Jul 15, 2019
Status verified
Aug 2024
Primary completion
Oct 31, 2030
Completion
Oct 31, 2030

Study Design

Enrollment
450 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Crohn's disease
    Fecal Microbiota Transplant will be performed.
  • Experimental: Ulcerative colitis
    Fecal Microbiota Transplant will be performed.
  • Experimental: Celiac disease
    Fecal Microbiota Transplant will be performed.
  • Experimental: Irritable bowel syndrome
    Fecal Microbiota Transplant will be performed.
  • Experimental: Functional dyspepsia
    Fecal Microbiota Transplant will be performed.
  • Experimental: Constipation
    Fecal Microbiota Transplant will be performed.
  • Experimental: Metabolic disease (diabetes mellitus or obesity)
    Fecal Microbiota Transplant will be performed.
  • Experimental: Multidrug-resistant infection
    Fecal Microbiota Transplant will be performed.
  • Experimental: Hepatic encephalopathy
    Fecal Microbiota Transplant will be performed.
  • Experimental: Multiple sclerosis
    Fecal Microbiota Transplant will be performed.
  • Experimental: Pseudo-obstruction
    Fecal Microbiota Transplant will be performed.
  • Experimental: CRE infection
    Fecal Microbiota Transplant will be performed.
  • Experimental: VRE infection
    Fecal Microbiota Transplant will be performed.
  • Experimental: Multiple organ dysfunction
    Fecal Microbiota Transplant will be performed.
  • Experimental: Dysbiotic bowel syndrome
    Fecal Microbiota Transplant will be performed.
  • Experimental: MRSA enteritis
    Fecal Microbiota Transplant will be performed.
  • Experimental: Pseudomembranous enteritis
    Fecal Microbiota Transplant will be performed.
  • Experimental: Alopecia
    Fecal Microbiota Transplant will be performed.
  • Experimental: Autism
    Fecal Microbiota Transplant will be performed.
  • Experimental: Graft-versus-host disease
    Fecal Microbiota Transplant will be performed.
  • Experimental: Idiopathic thrombocytopenic purpura
    Fecal Microbiota Transplant will be performed.
  • Experimental: Atopy or allergy
    Fecal Microbiota Transplant will be performed.
  • Experimental: Liver disease
    Fecal Microbiota Transplant will be performed.
  • Experimental: Alcohol dependence
    Fecal Microbiota Transplant will be performed.
  • Experimental: Antibiotic-associated diarrhea
    Fecal Microbiota Transplant will be performed.

Primary Outcome Measure

The efficacy of FMT in treating dysbiosis-associated disorder will be assessed by number of patients who have improvement in clinical symptoms (depends on each disease as stated in outcome) [ Time Frame: 1 year ]

Central Contacts

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