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 : May 30, 2023

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Sponsor:

Information provided by (Responsible Party):

Siew Chien NG, Chinese University of Hong Kong

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

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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
Actual Study Start Date :	July 15, 2019
Estimated Primary Completion Date :	October 31, 2023
Estimated Study Completion Date :	October 31, 2030

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Immune thrombocytopenia

MedlinePlus related topics: Bowel Movement

Genetic and Rare Diseases Information Center resources: Immune Thrombocytopenia Idiopathic Thrombocytopenic Purpura Homologous Wasting Disease Hepatic Encephalopathy Spondylarthropathy

U.S. FDA Resources

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 :

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 :

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

Other Outcome Measures:

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

Eligibility Criteria

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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

Contacts and Locations

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: Matthew Fung	+852 35053855	mfung@cuhk.edu.hk

Locations

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Hong Kong
The Chinese University of Hong Kong	Recruiting
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

More Information

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.

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. No abstract available.

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, Lowenberg 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 MG, Kim PT, Libertucci J, Wolfe M, Onischi C, Armstrong D, Marshall JK, Kassam Z, Reinisch W, Lee CH. Fecal Microbiota Transplantation Induces Remission in Patients With Active Ulcerative Colitis in a Randomized Controlled Trial. Gastroenterology. 2015 Jul;149(1):102-109.e6. doi: 10.1053/j.gastro.2015.04.001. Epub 2015 Apr 7.

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. No abstract available.

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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:	May 30, 2023
Last Verified:	May 2023
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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Immune System Diseases Thrombocytopenia Infections 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 Alopecia Graft vs Host Disease Syndrome Constipation Multiple Organ Failure Alcoholism Disease Pathologic Processes Disease Attributes

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