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Safety and Efficacy of Fecal Microbiota Transplantation

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ClinicalTrials.gov Identifier: NCT04014413
Recruitment Status : Recruiting
First Posted : July 10, 2019
Last Update Posted : April 22, 2020
Sponsor:
Information provided by (Responsible Party):
Siew Chien NG, Chinese University of Hong Kong

Tracking Information
First Submitted Date  ICMJE June 21, 2019
First Posted Date  ICMJE July 10, 2019
Last Update Posted Date April 22, 2020
Actual Study Start Date  ICMJE July 15, 2019
Estimated Primary Completion Date October 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 8, 2019)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 8, 2019)
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0 [ Time Frame: 1 year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 8, 2019)
Any improvement or deterioration or recurrence of the underlying condition by clinical judgement of doctors [ Time Frame: 1 year ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Fecal Microbiota Transplantation
Official Title  ICMJE Safety and Efficacy of Fecal Microbiota Transplantation: A Pilot Study
Brief 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • 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
Intervention  ICMJE Procedure: Fecal Microbiota Transplantation
Fecal microbiota transplantation
Study Arms  ICMJE
  • Experimental: Crohn's disease
    Fecal Microbiota Transplant will be performed.
    Intervention: Procedure: Fecal Microbiota Transplantation
  • Experimental: Ulcerative colitis
    Fecal Microbiota Transplant will be performed.
    Intervention: Procedure: Fecal Microbiota Transplantation
  • Experimental: Celiac disease
    Fecal Microbiota Transplant will be performed.
    Intervention: Procedure: Fecal Microbiota Transplantation
  • Experimental: Irritable bowel syndrome
    Fecal Microbiota Transplant will be performed.
    Intervention: Procedure: Fecal Microbiota Transplantation
  • Experimental: Functional dyspepsia
    Fecal Microbiota Transplant will be performed.
    Intervention: Procedure: Fecal Microbiota Transplantation
  • Experimental: Constipation
    Fecal Microbiota Transplant will be performed.
    Intervention: Procedure: Fecal Microbiota Transplantation
  • Experimental: Metabolic disease (diabetes mellitus or obesity)
    Fecal Microbiota Transplant will be performed.
    Intervention: Procedure: Fecal Microbiota Transplantation
  • Experimental: Multidrug-resistant infection
    Fecal Microbiota Transplant will be performed.
    Intervention: Procedure: Fecal Microbiota Transplantation
  • Experimental: Hepatic encephalopathy
    Fecal Microbiota Transplant will be performed.
    Intervention: Procedure: Fecal Microbiota Transplantation
  • Experimental: Multiple sclerosis
    Fecal Microbiota Transplant will be performed.
    Intervention: Procedure: Fecal Microbiota Transplantation
  • Experimental: Pseudo-obstruction
    Fecal Microbiota Transplant will be performed.
    Intervention: Procedure: Fecal Microbiota Transplantation
  • Experimental: CRE infection
    Fecal Microbiota Transplant will be performed.
    Intervention: Procedure: Fecal Microbiota Transplantation
  • Experimental: VRE infection
    Fecal Microbiota Transplant will be performed.
    Intervention: Procedure: Fecal Microbiota Transplantation
  • Experimental: Multiple organ dysfunction
    Fecal Microbiota Transplant will be performed.
    Intervention: Procedure: Fecal Microbiota Transplantation
  • Experimental: Dysbiotic bowel syndrome
    Fecal Microbiota Transplant will be performed.
    Intervention: Procedure: Fecal Microbiota Transplantation
  • Experimental: MRSA enteritis
    Fecal Microbiota Transplant will be performed.
    Intervention: Procedure: Fecal Microbiota Transplantation
  • Experimental: Pseudomembranous enteritis
    Fecal Microbiota Transplant will be performed.
    Intervention: Procedure: Fecal Microbiota Transplantation
  • Experimental: Alopecia
    Fecal Microbiota Transplant will be performed.
    Intervention: Procedure: Fecal Microbiota Transplantation
  • Experimental: Autism
    Fecal Microbiota Transplant will be performed.
    Intervention: Procedure: Fecal Microbiota Transplantation
  • Experimental: Graft-versus-host disease
    Fecal Microbiota Transplant will be performed.
    Intervention: Procedure: Fecal Microbiota Transplantation
  • Experimental: Idiopathic thrombocytopenic purpura
    Fecal Microbiota Transplant will be performed.
    Intervention: Procedure: Fecal Microbiota Transplantation
  • Experimental: Atopy or allergy
    Fecal Microbiota Transplant will be performed.
    Intervention: Procedure: Fecal Microbiota Transplantation
  • Experimental: Liver disease
    Fecal Microbiota Transplant will be performed.
    Intervention: Procedure: Fecal Microbiota Transplantation
  • Experimental: Alcohol dependence
    Fecal Microbiota Transplant will be performed.
    Intervention: Procedure: Fecal Microbiota Transplantation
  • Experimental: Antibiotic-associated diarrhea
    Fecal Microbiota Transplant will be performed.
    Intervention: Procedure: Fecal Microbiota Transplantation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 8, 2019)
450
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 31, 2024
Estimated Primary Completion Date October 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kitty Cheung +852 26373260 kittyccy@cuhk.edu.hk
Contact: Amy Li +852 26373260 amyli@cuhk.edu.hk
Listed Location Countries  ICMJE Hong Kong
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04014413
Other Study ID Numbers  ICMJE FMT-Pilot
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Siew Chien NG, Chinese University of Hong Kong
Study Sponsor  ICMJE Chinese University of Hong Kong
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Siew Ng Chinese University of Hong Kong
PRS Account Chinese University of Hong Kong
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP