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出境医 / 临床实验 / Safety and Efficacy of Fecal Microbiota Transplantation

Safety and Efficacy of Fecal Microbiota Transplantation

Study Description
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

Study Design
Layout table for study information
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
Actual Study Start Date : July 15, 2019
Estimated Primary Completion Date : October 31, 2023
Estimated Study Completion Date : October 31, 2024
Arms and Interventions
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
Outcome Measures
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 ]

Eligibility Criteria
Layout table for eligibility information
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
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Kitty Cheung +852 26373260 kittyccy@cuhk.edu.hk
Contact: Amy Li +852 26373260 amyli@cuhk.edu.hk

Locations
Layout table for location information
Hong Kong
The Chinese University of Hong Kong Recruiting
Hong Kong, Shatin, Hong Kong, 000000
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Layout table for investigator information
Principal Investigator: Siew 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 *
  • Brandt LJ. American Journal of Gastroenterology Lecture: Intestinal microbiota and the role of fecal microbiota transplant (FMT) in treatment of C. difficile infection. Am J Gastroenterol. 2013 Feb;108(2):177-85. doi: 10.1038/ajg.2012.450. Epub 2013 Jan 15. Review.
  • Philips CA, Pande A, Shasthry SM, Jamwal KD, Khillan V, Chandel SS, Kumar G, Sharma MK, Maiwall R, Jindal A, Choudhary A, Hussain MS, Sharma S, Sarin SK. Healthy Donor Fecal Microbiota Transplantation in Steroid-Ineligible Severe Alcoholic Hepatitis: A Pilot Study. Clin Gastroenterol Hepatol. 2017 Apr;15(4):600-602. doi: 10.1016/j.cgh.2016.10.029. Epub 2016 Nov 2. Review.
  • 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
  • Paramsothy S, Kamm MA, Kaakoush NO, Walsh AJ, van den Bogaerde J, Samuel D, Leong RWL, Connor S, Ng W, Paramsothy R, Xuan W, Lin E, Mitchell HM, Borody TJ. Multidonor intensive faecal microbiota transplantation for active ulcerative colitis: a randomised placebo-controlled trial. Lancet. 2017 Mar 25;389(10075):1218-1228. doi: 10.1016/S0140-6736(17)30182-4. Epub 2017 Feb 15.
  • Rossen NG, Fuentes S, van der Spek MJ, Tijssen JG, Hartman JH, Duflou A, Löwenberg M, van den Brink GR, Mathus-Vliegen EM, de Vos WM, Zoetendal EG, D'Haens GR, Ponsioen CY. Findings From a Randomized Controlled Trial of Fecal Transplantation for Patients With Ulcerative Colitis. Gastroenterology. 2015 Jul;149(1):110-118.e4. doi: 10.1053/j.gastro.2015.03.045. Epub 2015 Mar 30.
  • 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.
  • Mullish BH, McDonald JAK, Thursz MR, Marchesi JR. Fecal microbiota transplant from a rational stool donor improves hepatic encephalopathy: A randomized clinical trial. Hepatology. 2017 Oct;66(4):1354-1355. doi: 10.1002/hep.29369. Epub 2017 Aug 26.

*   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

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