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Safety and Efficacy of Fecal Microbiota Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04014413
Recruitment Status : Not yet recruiting
First Posted : July 10, 2019
Last Update Posted : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
Siew Chien NG, Chinese University of Hong Kong

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.


Condition or disease Intervention/treatment Phase
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 Procedure: Fecal Microbiota Transplantation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Fecal Microbiota Transplantation: A Pilot Study
Estimated Study Start Date : July 15, 2019
Estimated Primary Completion Date : October 31, 2023
Estimated Study Completion Date : October 31, 2024


Arm Intervention/treatment
Experimental: Crohn's disease
Fecal Microbiota Transplant will be performed.
Procedure: Fecal Microbiota Transplantation
Fecal microbiota transplantation

Experimental: Ulcerative colitis
Fecal Microbiota Transplant will be performed.
Procedure: Fecal Microbiota Transplantation
Fecal microbiota transplantation

Experimental: Celiac disease
Fecal Microbiota Transplant will be performed.
Procedure: Fecal Microbiota Transplantation
Fecal microbiota transplantation

Experimental: Irritable bowel syndrome
Fecal Microbiota Transplant will be performed.
Procedure: Fecal Microbiota Transplantation
Fecal microbiota transplantation

Experimental: Functional dyspepsia
Fecal Microbiota Transplant will be performed.
Procedure: Fecal Microbiota Transplantation
Fecal microbiota transplantation

Experimental: Constipation
Fecal Microbiota Transplant will be performed.
Procedure: Fecal Microbiota Transplantation
Fecal microbiota transplantation

Experimental: Metabolic disease (diabetes mellitus or obesity)
Fecal Microbiota Transplant will be performed.
Procedure: Fecal Microbiota Transplantation
Fecal microbiota transplantation

Experimental: Multidrug-resistant infection
Fecal Microbiota Transplant will be performed.
Procedure: Fecal Microbiota Transplantation
Fecal microbiota transplantation

Experimental: Hepatic encephalopathy
Fecal Microbiota Transplant will be performed.
Procedure: Fecal Microbiota Transplantation
Fecal microbiota transplantation

Experimental: Multiple sclerosis
Fecal Microbiota Transplant will be performed.
Procedure: Fecal Microbiota Transplantation
Fecal microbiota transplantation

Experimental: Pseudo-obstruction
Fecal Microbiota Transplant will be performed.
Procedure: Fecal Microbiota Transplantation
Fecal microbiota transplantation

Experimental: CRE infection
Fecal Microbiota Transplant will be performed.
Procedure: Fecal Microbiota Transplantation
Fecal microbiota transplantation

Experimental: VRE infection
Fecal Microbiota Transplant will be performed.
Procedure: Fecal Microbiota Transplantation
Fecal microbiota transplantation

Experimental: Multiple organ dysfunction
Fecal Microbiota Transplant will be performed.
Procedure: Fecal Microbiota Transplantation
Fecal microbiota transplantation

Experimental: Dysbiotic bowel syndrome
Fecal Microbiota Transplant will be performed.
Procedure: Fecal Microbiota Transplantation
Fecal microbiota transplantation

Experimental: MRSA enteritis
Fecal Microbiota Transplant will be performed.
Procedure: Fecal Microbiota Transplantation
Fecal microbiota transplantation

Experimental: Pseudomembranous enteritis
Fecal Microbiota Transplant will be performed.
Procedure: Fecal Microbiota Transplantation
Fecal microbiota transplantation

Experimental: Alopecia
Fecal Microbiota Transplant will be performed.
Procedure: Fecal Microbiota Transplantation
Fecal microbiota transplantation

Experimental: Autism
Fecal Microbiota Transplant will be performed.
Procedure: Fecal Microbiota Transplantation
Fecal microbiota transplantation

Experimental: Graft-versus-host disease
Fecal Microbiota Transplant will be performed.
Procedure: Fecal Microbiota Transplantation
Fecal microbiota transplantation

Experimental: Idiopathic thrombocytopenic purpura
Fecal Microbiota Transplant will be performed.
Procedure: Fecal Microbiota Transplantation
Fecal microbiota transplantation

Experimental: Atopy or allergy
Fecal Microbiota Transplant will be performed.
Procedure: Fecal Microbiota Transplantation
Fecal microbiota transplantation

Experimental: Liver disease
Fecal Microbiota Transplant will be performed.
Procedure: Fecal Microbiota Transplantation
Fecal microbiota transplantation

Experimental: Alcohol dependence
Fecal Microbiota Transplant will be performed.
Procedure: Fecal Microbiota Transplantation
Fecal microbiota transplantation

Experimental: Antibiotic-associated diarrhea
Fecal Microbiota Transplant will be performed.
Procedure: Fecal Microbiota Transplantation
Fecal microbiota transplantation




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0 [ Time Frame: 1 year ]

Other Outcome Measures:
  1. Any improvement or deterioration or recurrence of the underlying condition by clinical judgement of doctors [ Time Frame: 1 year ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04014413


Contacts
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Contact: Kitty Cheung +852 26373260 kittyccy@cuhk.edu.hk
Contact: Amy Li +852 26373260 amyli@cuhk.edu.hk

Locations
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Hong Kong
The Chinese University of Hong Kong
Hong Kong, Shatin, Hong Kong, 000000
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
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Principal Investigator: Siew Ng Chinese University of Hong Kong

Publications:
Yang Z, Wang X, Bu C. Fecal microbiota transplant for Crohn's disease: a prospective, randomized study in chinese population. United european gastroenterology journal. Conference: 25th united european gastroenterology week, UEG 2017. Spain. Volume 5, 2017:A112-a113
Moayyedi P, Surette M, Wolfe M, et al. A randomized, placebo controlled trial of fecal microbiota therapy in active ulcerative colitis. Gastroenterology 2014;1):S-159
Costello SP, Waters O, Bryant RV, et al. Short duration, low intensity, pooled fecal microbiota transplantation induces remission in patients with mildmoderately active ulcerative colitis: A randomised controlled trial. Gastroenterology 2017;152 (5 Supplement 1):S198-S199
Kirk KF, Kousgaard SJ, Nielsen HL, et al. Faecal transplant for the treatment of chronic pouchitis-A randomised, placebo-controlled, clinical trial. Colorectal Disease 2017;19 (Supplement 2):143
Johnsen PH, Hilpusch F, Cavanagh JP, et al. Fecal transplantation in Irritable Bowel Syndrome (IBS): An RCT. Neurogastroenterology and Motility 2017;29 (Supplement 2):135.
Holster S, Repsilber D, Brummer RJ, et al. Faecal microbiota transfer in irritable bowel syndrome-clinical outcomes of a randomised placebo-controlled trial. United European Gastroenterology Journal 2017;5 (5 Supplement 1):A155-A156.
Holster S, Brummer RJ, Repsilber D, et al. Fecal microbiota transplantation in irritable bowel syndrome and a randomized placebo-controlled trial. Gastroenterology 2017;152 (5 Supplement 1):S101-S102.
Holger Johnsen P, Mazzawi T, El-Salhy M, et al. Effect of faecal microbiota transplantation on the enteroendocrine cells of the colon in patients with Irritable Bowel Syndrome (IBS): Double blinded-placebo controlled study. Neurogastroenterology and Motility 2017;29 (Supplement 2):71.
Bajaj JS, Kassam Z, Fagan A, et al. Fecal microbiota transplant using a precision medicine approach is safe, Associated with lower hospitalization risk and improved cognitive function in recurrent hepatic encephalopathy. Journal of Hepatology 2017;66:S49-S49.

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Responsible Party: Siew Chien NG, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT04014413    
Other Study ID Numbers: FMT-Pilot
First Posted: July 10, 2019    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alopecia
Infection
Communicable Diseases
Clostridium Infections
Enterobacteriaceae Infections
Enterocolitis, Pseudomembranous
Arthritis, Psoriatic
Crohn Disease
Liver Diseases
Irritable Bowel Syndrome
Celiac Disease
Hepatic Encephalopathy
Enterocolitis
Enteritis
Dysphonia
Multiple Sclerosis
Brain Diseases
Purpura
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Graft vs Host Disease
Syndrome
Constipation
Multiple Organ Failure
Alcoholism
Disease
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases