Efficacy and Safety of Fecal Microbiota Transplantation (FMT)

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ClinicalTrials.gov Identifier: NCT04706611

Recruitment Status : Recruiting

First Posted : January 13, 2021

Last Update Posted : April 8, 2021

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Sponsor:

Information provided by (Responsible Party):

Guangzhou First People's Hospital

Study Description

Brief Summary:

In recent years, researches illustrate that multifactorial diseases such as functional gastrointestinal disorders, autoimmune diseases, metabolic, behavioral and neurological diseases are associated with an abnormal microbiome structure-dysbiosis, which means the imbalance of the microbiome community. Fecal microbiota transplantation (FMT), the infusion of faeces from a healthy donor to the gastrointestinal tract of a recipient patient aiming to alter the intestine microbiota, is recommended to be performed in Clostridium difficile infection(CDI) as the most effective therapy. It also being used experimentally in the treatment of the disease states linked to dysbiosis of the intestinal microbiota. However, the efficacy and safety of FMT to treat the dysbiosis-associated diseases is still in its infancy. To further verify the indications above, more data is required to be collected through studies.

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

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	300 participants
Allocation:	Non-Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Efficacy and Safety of Fecal Microbiota Transplantation in Patients With Intestinal Dysbiosis -A Pilot Study
Actual Study Start Date :	January 15, 2021
Estimated Primary Completion Date :	December 31, 2025
Estimated Study Completion Date :	December 31, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Irritable Bowel Syndrome Fecal Microbiota Transplantation will be performed.	Procedure: Fecal Microbiota Transplantation Procedure: Fecal Microbiota Transplantation
Experimental: Constipation Fecal Microbiota Transplantation will be performed.	Procedure: Fecal Microbiota Transplantation Procedure: Fecal Microbiota Transplantation
Experimental: Clostridium Difficile Infection Fecal Microbiota Transplantation will be performed.	Procedure: Fecal Microbiota Transplantation Procedure: Fecal Microbiota Transplantation
Experimental: Functional Dyspepsia Fecal Microbiota Transplantation will be performed.	Procedure: Fecal Microbiota Transplantation Procedure: Fecal Microbiota Transplantation
Experimental: Parkinson's Disease Fecal Microbiota Transplantation will be performed.	Procedure: Fecal Microbiota Transplantation Procedure: Fecal Microbiota Transplantation
Experimental: Metabolic Syndrome Fecal Microbiota Transplantation will be performed.	Procedure: Fecal Microbiota Transplantation Procedure: Fecal Microbiota Transplantation
Experimental: Non-Alcoholic Fatty Liver Disease Fecal Microbiota Transplantation will be performed.	Procedure: Fecal Microbiota Transplantation Procedure: Fecal Microbiota Transplantation
Experimental: Autism Spectrum Disorder Fecal Microbiota Transplantation will be performed.	Procedure: Fecal Microbiota Transplantation Procedure: Fecal Microbiota Transplantation
Experimental: Radiation Enteritis Fecal Microbiota Transplantation will be performed.	Procedure: Fecal Microbiota Transplantation Procedure: Fecal Microbiota Transplantation
Experimental: Atopic Dermatitis Fecal Microbiota Transplantation will be performed.	Procedure: Fecal Microbiota Transplantation Procedure: Fecal Microbiota Transplantation
Experimental: Food Allergic Fecal Microbiota Transplantation will be performed.	Procedure: Fecal Microbiota Transplantation Procedure: Fecal Microbiota Transplantation
Experimental: Graft-versus-Host Disease Fecal Microbiota Transplantation will be performed.	Procedure: Fecal Microbiota Transplantation Procedure: Fecal Microbiota Transplantation
Experimental: Obesity Fecal Microbiota Transplantation will be performed.	Procedure: Fecal Microbiota Transplantation Procedure: Fecal Microbiota Transplantation
Experimental: Diabetes mellitus Fecal Microbiota Transplantation will be performed.	Procedure: Fecal Microbiota Transplantation Procedure: Fecal Microbiota Transplantation
Experimental: Multi-Drug Resistant Infection Fecal Microbiota Transplantation will be performed.	Procedure: Fecal Microbiota Transplantation Procedure: Fecal Microbiota Transplantation
Experimental: Hepatic Encephalopathy Fecal Microbiota Transplantation will be performed.	Procedure: Fecal Microbiota Transplantation Procedure: Fecal Microbiota Transplantation
Experimental: Enteric Dysbacteriosis Fecal Microbiota Transplantation will be performed.	Procedure: Fecal Microbiota Transplantation Procedure: Fecal Microbiota Transplantation
Experimental: Multiple Sclerosis Fecal Microbiota Transplantation will be performed.	Procedure: Fecal Microbiota Transplantation Procedure: Fecal Microbiota Transplantation
Experimental: Pseudomembranous Enteritis Fecal Microbiota Transplantation will be performed.	Procedure: Fecal Microbiota Transplantation Procedure: Fecal Microbiota Transplantation
Experimental: Acute Pancreatitis Fecal Microbiota Transplantation will be performed.	Procedure: Fecal Microbiota Transplantation Procedure: Fecal Microbiota Transplantation
Experimental: Chronic Fatigue Syndrome Fecal Microbiota Transplantation will be performed.	Procedure: Fecal Microbiota Transplantation Procedure: Fecal Microbiota Transplantation
Experimental: Acute-on-chronic Liver Failure with HBV Infection Fecal Microbiota Transplantation will be performed.	Procedure: Fecal Microbiota Transplantation Procedure: Fecal Microbiota Transplantation
Experimental: Alcoholic Liver Disease Fecal Microbiota Transplantation will be performed.	Procedure: Fecal Microbiota Transplantation Procedure: Fecal Microbiota Transplantation
Experimental: Anorexia Fecal Microbiota Transplantation will be performed.	Procedure: Fecal Microbiota Transplantation Procedure: Fecal Microbiota Transplantation
Experimental: Decompensated Cirrhosis Fecal Microbiota Transplantation will be performed.	Procedure: Fecal Microbiota Transplantation Procedure: Fecal Microbiota Transplantation
Experimental: Henoch-Schonlein Purpura Fecal Microbiota Transplantation will be performed.	Procedure: Fecal Microbiota Transplantation Procedure: Fecal Microbiota Transplantation
Experimental: Autoimmune Liver Disease Fecal Microbiota Transplantation will be performed.	Procedure: Fecal Microbiota Transplantation Procedure: Fecal Microbiota Transplantation
Experimental: Systemic Lupus Erythematosus Fecal Microbiota Transplantation will be performed.	Procedure: Fecal Microbiota Transplantation Procedure: Fecal Microbiota Transplantation
Experimental: IgG4-Related Disease Fecal Microbiota Transplantation will be performed.	Procedure: Fecal Microbiota Transplantation Procedure: Fecal Microbiota Transplantation
Experimental: Celiac Disease Fecal Microbiota Transplantation will be performed.	Procedure: Fecal Microbiota Transplantation Procedure: Fecal Microbiota Transplantation
Experimental: Protein-losing Enteropathy Fecal Microbiota Transplantation will be performed.	Procedure: Fecal Microbiota Transplantation Procedure: Fecal Microbiota Transplantation
Experimental: Asperger Syndrome Fecal Microbiota Transplantation will be performed.	Procedure: Fecal Microbiota Transplantation Procedure: Fecal Microbiota Transplantation
Experimental: Rheumatoid arthritis Fecal Microbiota Transplantation will be performed.	Procedure: Fecal Microbiota Transplantation Procedure: Fecal Microbiota Transplantation
Experimental: Ulcerative colitis Fecal Microbiota Transplantation will be performed.	Procedure: Fecal Microbiota Transplantation Procedure: Fecal Microbiota Transplantation
Experimental: Crohn's disease Fecal Microbiota Transplantation will be performed.	Procedure: Fecal Microbiota Transplantation Procedure: Fecal Microbiota Transplantation
Experimental: Psoriasis Fecal Microbiota Transplantation will be performed.	Procedure: Fecal Microbiota Transplantation Procedure: Fecal Microbiota Transplantation
Experimental: Ankylosing spondylitis Fecal Microbiota Transplantation will be performed.	Procedure: Fecal Microbiota Transplantation Procedure: Fecal Microbiota Transplantation
Experimental: Immune checkpoint inhibition-related colitis Fecal Microbiota Transplantation will be performed.	Procedure: Fecal Microbiota Transplantation Procedure: Fecal Microbiota Transplantation
Experimental: Autoimmune enteropathy Fecal Microbiota Transplantation will be performed.	Procedure: Fecal Microbiota Transplantation Procedure: Fecal Microbiota Transplantation
Experimental: Drug-induced diarrhea Fecal Microbiota Transplantation will be performed.	Procedure: Fecal Microbiota Transplantation Procedure: Fecal Microbiota Transplantation

Outcome Measures

Primary Outcome Measures :

The efficacy of FMT in patients with gastrointestinal symptom will be assessed by the change of Gastrointestinal Symptom Rating Scale(GSRS). [ Time Frame: 1 year ]
Gastrointestinal Symptom Rating Scale(GSRS) is a measure of gastrointestinal symptom severity in five clusters (pain, bloating, constipation, diarrhea, and early satiety).The items are scored between 1 and 7, where 1 corresponds to "no discomfort at all" and 7 to "very severe discomfort" from the symptom. The participants will be asked to filled in the scale in several time points from baseline to 12 months after FMT.

Secondary Outcome Measures :

Number of Participants With Treatment-Related Adverse Events as Assessed by Common Terminology Criteria for Adverse Events(CTCAE) V4.0 [ Time Frame: 1 year ]

Other Outcome Measures:

Numbers of patients who have improvement in clinical symptoms (depends on each disease as stated in outcome) [ Time Frame: 1 year ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 70 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Confirmed diagnosis of any of following diseases:

Irritable Bowel Syndrome
Ulcerative colitis
Crohn's disease
Constipation
Clostridium Difficile Infection
Functional Dyspepsia
Parkinson's Disease
Metabolic Syndrome
Non-Alcoholic Fatty Liver Disease
Autism Spectrum Disorder
Radiation Enteritis
Atopic Dermatitis
Food Allergic
Graft-versus-Host Disease
Obesity
Diabetes mellitus
Multi-Drug Resistant Infection
Hepatic Encephalopathy
Enteric Dysbacteriosis
Multiple Sclerosis
Pseudomembranous Enteritis
Acute Pancreatitis
Chronic Fatigue Syndrome
Acute-on-chronic Liver Failure with HBV Infection
Alcoholic Liver Disease
Anorexia
Decompensated Cirrhosis
Henoch-Schonlein Purpura
Autoimmune Liver Disease
Systemic Lupus Erythematosus
Rheumatoid arthritis
IgG4-Related Disease
Celiac Disease
Protein-losing Enteropathy
Asperger Syndrome
Rheumatoid arthritis
Psoriasis
Ankylosing spondylitis
Immune checkpoint inhibition-related colitis
Autoimmune enteropathy
Drug-induced diarrhea
Suffering from gastrointestinal symptoms such as constipation, diarrheas, abdominal pain, flatulence, etc.
The participants must be able to tolerate the FMT infusion method such as endoscopy, colonoscopy, capsule, nasoduodenal tube insertion, etc.

Exclusion Criteria:

Current pregnancy or breast-feeding;
Suffering from other severe diseases, including liver or kidney failure, heart failure, MODS, coma, cerebrovascular accident;
Known contraindication to all FMT infusion method such as nasoduodenal tube insertion, endoscopy, colonoscopy and enema;
Any conditions that may render the efficacy of FMT or at the discretion of the investigators.

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): NCT04706611

Contacts

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Contact: Yongjian Zhou, MM	86-13503060150	eyzhouyongjian@scut.edu.cn
Contact: Hongli Huang, MM	86-13631316718	honglisums@126.com

Locations

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China, Guangdong
Guangzhou First People's Hospital	Recruiting
Guangzhou, Guangdong, China, 510180
Contact: Yongjian Zhou, MM 86-13503060150 eyzhouyongjian@scut.edu.cn
Contact: Hongli Huang, MM 86-13631316718 honglisums@126.com
Sub-Investigator: Yandi Liu, MM

Sponsors and Collaborators

Guangzhou First People's Hospital

Investigators

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Principal Investigator:	Hongli Huang, MM	Guangzhou First People's Hospital

More Information

Publications:

Levy M, Kolodziejczyk AA, Thaiss CA, Elinav E. Dysbiosis and the immune system. Nat Rev Immunol. 2017 Apr;17(4):219-232. doi: 10.1038/nri.2017.7. Epub 2017 Mar 6.

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.

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.

Ooijevaar RE, Terveer EM, Verspaget HW, Kuijper EJ, Keller JJ. Clinical Application and Potential of Fecal Microbiota Transplantation. Annu Rev Med. 2019 Jan 27;70:335-351. doi: 10.1146/annurev-med-111717-122956. Epub 2018 Nov 7.

Lee P, Yacyshyn BR, Yacyshyn MB. Gut microbiota and obesity: An opportunity to alter obesity through faecal microbiota transplant (FMT). Diabetes Obes Metab. 2019 Mar;21(3):479-490. doi: 10.1111/dom.13561. Epub 2018 Nov 20.

Bajaj JS, Kassam Z, Fagan A, Gavis EA, Liu E, Cox IJ, Kheradman R, Heuman D, Wang J, Gurry T, Williams R, Sikaroodi M, Fuchs M, Alm E, John B, Thacker LR, Riva A, Smith M, Taylor-Robinson SD, Gillevet PM. Fecal microbiota transplant from a rational stool donor improves hepatic encephalopathy: A randomized clinical trial. Hepatology. 2017 Dec;66(6):1727-1738. doi: 10.1002/hep.29306. Epub 2017 Oct 30.

Sun MF, Zhu YL, Zhou ZL, Jia XB, Xu YD, Yang Q, Cui C, Shen YQ. Neuroprotective effects of fecal microbiota transplantation on MPTP-induced Parkinson's disease mice: Gut microbiota, glial reaction and TLR4/TNF-alpha signaling pathway. Brain Behav Immun. 2018 May;70:48-60. doi: 10.1016/j.bbi.2018.02.005. Epub 2018 Feb 20.

Johnsen PH, Hilpusch F, Cavanagh JP, Leikanger IS, Kolstad C, Valle PC, Goll R. Faecal microbiota transplantation versus placebo for moderate-to-severe irritable bowel syndrome: a double-blind, randomised, placebo-controlled, parallel-group, single-centre trial. Lancet Gastroenterol Hepatol. 2018 Jan;3(1):17-24. doi: 10.1016/S2468-1253(17)30338-2. Epub 2017 Nov 1.

El-Salhy M, Hatlebakk JG, Gilja OH, Brathen Kristoffersen A, Hausken T. Efficacy of faecal microbiota transplantation for patients with irritable bowel syndrome in a randomised, double-blind, placebo-controlled study. Gut. 2020 May;69(5):859-867. doi: 10.1136/gutjnl-2019-319630. Epub 2019 Dec 18.

Leshem A, Horesh N, Elinav E. Fecal Microbial Transplantation and Its Potential Application in Cardiometabolic Syndrome. Front Immunol. 2019 Jun 14;10:1341. doi: 10.3389/fimmu.2019.01341. eCollection 2019.

DeFilipp Z, Bloom PP, Torres Soto M, Mansour MK, Sater MRA, Huntley MH, Turbett S, Chung RT, Chen YB, Hohmann EL. Drug-Resistant E. coli Bacteremia Transmitted by Fecal Microbiota Transplant. N Engl J Med. 2019 Nov 21;381(21):2043-2050. doi: 10.1056/NEJMoa1910437. Epub 2019 Oct 30.

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Responsible Party:	Guangzhou First People's Hospital
ClinicalTrials.gov Identifier:	NCT04706611
Other Study ID Numbers:	B-2019-041-01
First Posted:	January 13, 2021 Key Record Dates
Last Update Posted:	April 8, 2021
Last Verified:	February 2021
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

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