Efficacy and Safety of Fecal Microbiota Transplantation

NCT ID: NCT04706611

Last Updated: 2021-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-15

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Fecal Microbiota Transplantation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Irritable Bowel Syndrome

Fecal Microbiota Transplantation will be performed.

Group Type EXPERIMENTAL

Fecal Microbiota Transplantation

Intervention Type PROCEDURE

Procedure: Fecal Microbiota Transplantation

Constipation

Fecal Microbiota Transplantation will be performed.

Group Type EXPERIMENTAL

Fecal Microbiota Transplantation

Intervention Type PROCEDURE

Procedure: Fecal Microbiota Transplantation

Clostridium Difficile Infection

Fecal Microbiota Transplantation will be performed.

Group Type EXPERIMENTAL

Fecal Microbiota Transplantation

Intervention Type PROCEDURE

Procedure: Fecal Microbiota Transplantation

Functional Dyspepsia

Fecal Microbiota Transplantation will be performed.

Group Type EXPERIMENTAL

Fecal Microbiota Transplantation

Intervention Type PROCEDURE

Procedure: Fecal Microbiota Transplantation

Parkinson's Disease

Fecal Microbiota Transplantation will be performed.

Group Type EXPERIMENTAL

Fecal Microbiota Transplantation

Intervention Type PROCEDURE

Procedure: Fecal Microbiota Transplantation

Metabolic Syndrome

Fecal Microbiota Transplantation will be performed.

Group Type EXPERIMENTAL

Fecal Microbiota Transplantation

Intervention Type PROCEDURE

Procedure: Fecal Microbiota Transplantation

Non-Alcoholic Fatty Liver Disease

Fecal Microbiota Transplantation will be performed.

Group Type EXPERIMENTAL

Fecal Microbiota Transplantation

Intervention Type PROCEDURE

Procedure: Fecal Microbiota Transplantation

Autism Spectrum Disorder

Fecal Microbiota Transplantation will be performed.

Group Type EXPERIMENTAL

Fecal Microbiota Transplantation

Intervention Type PROCEDURE

Procedure: Fecal Microbiota Transplantation

Radiation Enteritis

Fecal Microbiota Transplantation will be performed.

Group Type EXPERIMENTAL

Fecal Microbiota Transplantation

Intervention Type PROCEDURE

Procedure: Fecal Microbiota Transplantation

Atopic Dermatitis

Fecal Microbiota Transplantation will be performed.

Group Type EXPERIMENTAL

Fecal Microbiota Transplantation

Intervention Type PROCEDURE

Procedure: Fecal Microbiota Transplantation

Food Allergic

Fecal Microbiota Transplantation will be performed.

Group Type EXPERIMENTAL

Fecal Microbiota Transplantation

Intervention Type PROCEDURE

Procedure: Fecal Microbiota Transplantation

Graft-versus-Host Disease

Fecal Microbiota Transplantation will be performed.

Group Type EXPERIMENTAL

Fecal Microbiota Transplantation

Intervention Type PROCEDURE

Procedure: Fecal Microbiota Transplantation

Obesity

Fecal Microbiota Transplantation will be performed.

Group Type EXPERIMENTAL

Fecal Microbiota Transplantation

Intervention Type PROCEDURE

Procedure: Fecal Microbiota Transplantation

Diabetes mellitus

Fecal Microbiota Transplantation will be performed.

Group Type EXPERIMENTAL

Fecal Microbiota Transplantation

Intervention Type PROCEDURE

Procedure: Fecal Microbiota Transplantation

Multi-Drug Resistant Infection

Fecal Microbiota Transplantation will be performed.

Group Type EXPERIMENTAL

Fecal Microbiota Transplantation

Intervention Type PROCEDURE

Procedure: Fecal Microbiota Transplantation

Hepatic Encephalopathy

Fecal Microbiota Transplantation will be performed.

Group Type EXPERIMENTAL

Fecal Microbiota Transplantation

Intervention Type PROCEDURE

Procedure: Fecal Microbiota Transplantation

Enteric Dysbacteriosis

Fecal Microbiota Transplantation will be performed.

Group Type EXPERIMENTAL

Fecal Microbiota Transplantation

Intervention Type PROCEDURE

Procedure: Fecal Microbiota Transplantation

Multiple Sclerosis

Fecal Microbiota Transplantation will be performed.

Group Type EXPERIMENTAL

Fecal Microbiota Transplantation

Intervention Type PROCEDURE

Procedure: Fecal Microbiota Transplantation

Pseudomembranous Enteritis

Fecal Microbiota Transplantation will be performed.

Group Type EXPERIMENTAL

Fecal Microbiota Transplantation

Intervention Type PROCEDURE

Procedure: Fecal Microbiota Transplantation

Acute Pancreatitis

Fecal Microbiota Transplantation will be performed.

Group Type EXPERIMENTAL

Fecal Microbiota Transplantation

Intervention Type PROCEDURE

Procedure: Fecal Microbiota Transplantation

Chronic Fatigue Syndrome

Fecal Microbiota Transplantation will be performed.

Group Type EXPERIMENTAL

Fecal Microbiota Transplantation

Intervention Type PROCEDURE

Procedure: Fecal Microbiota Transplantation

Acute-on-chronic Liver Failure with HBV Infection

Fecal Microbiota Transplantation will be performed.

Group Type EXPERIMENTAL

Fecal Microbiota Transplantation

Intervention Type PROCEDURE

Procedure: Fecal Microbiota Transplantation

Alcoholic Liver Disease

Fecal Microbiota Transplantation will be performed.

Group Type EXPERIMENTAL

Fecal Microbiota Transplantation

Intervention Type PROCEDURE

Procedure: Fecal Microbiota Transplantation

Anorexia

Fecal Microbiota Transplantation will be performed.

Group Type EXPERIMENTAL

Fecal Microbiota Transplantation

Intervention Type PROCEDURE

Procedure: Fecal Microbiota Transplantation

Decompensated Cirrhosis

Fecal Microbiota Transplantation will be performed.

Group Type EXPERIMENTAL

Fecal Microbiota Transplantation

Intervention Type PROCEDURE

Procedure: Fecal Microbiota Transplantation

Henoch-Schonlein Purpura

Fecal Microbiota Transplantation will be performed.

Group Type EXPERIMENTAL

Fecal Microbiota Transplantation

Intervention Type PROCEDURE

Procedure: Fecal Microbiota Transplantation

Autoimmune Liver Disease

Fecal Microbiota Transplantation will be performed.

Group Type EXPERIMENTAL

Fecal Microbiota Transplantation

Intervention Type PROCEDURE

Procedure: Fecal Microbiota Transplantation

Systemic Lupus Erythematosus

Fecal Microbiota Transplantation will be performed.

Group Type EXPERIMENTAL

Fecal Microbiota Transplantation

Intervention Type PROCEDURE

Procedure: Fecal Microbiota Transplantation

IgG4-Related Disease

Fecal Microbiota Transplantation will be performed.

Group Type EXPERIMENTAL

Fecal Microbiota Transplantation

Intervention Type PROCEDURE

Procedure: Fecal Microbiota Transplantation

Celiac Disease

Fecal Microbiota Transplantation will be performed.

Group Type EXPERIMENTAL

Fecal Microbiota Transplantation

Intervention Type PROCEDURE

Procedure: Fecal Microbiota Transplantation

Protein-losing Enteropathy

Fecal Microbiota Transplantation will be performed.

Group Type EXPERIMENTAL

Fecal Microbiota Transplantation

Intervention Type PROCEDURE

Procedure: Fecal Microbiota Transplantation

Asperger Syndrome

Fecal Microbiota Transplantation will be performed.

Group Type EXPERIMENTAL

Fecal Microbiota Transplantation

Intervention Type PROCEDURE

Procedure: Fecal Microbiota Transplantation

Rheumatoid arthritis

Fecal Microbiota Transplantation will be performed.

Group Type EXPERIMENTAL

Fecal Microbiota Transplantation

Intervention Type PROCEDURE

Procedure: Fecal Microbiota Transplantation

Ulcerative colitis

Fecal Microbiota Transplantation will be performed.

Group Type EXPERIMENTAL

Fecal Microbiota Transplantation

Intervention Type PROCEDURE

Procedure: Fecal Microbiota Transplantation

Crohn's disease

Fecal Microbiota Transplantation will be performed.

Group Type EXPERIMENTAL

Fecal Microbiota Transplantation

Intervention Type PROCEDURE

Procedure: Fecal Microbiota Transplantation

Psoriasis

Fecal Microbiota Transplantation will be performed.

Group Type EXPERIMENTAL

Fecal Microbiota Transplantation

Intervention Type PROCEDURE

Procedure: Fecal Microbiota Transplantation

Ankylosing spondylitis

Fecal Microbiota Transplantation will be performed.

Group Type EXPERIMENTAL

Fecal Microbiota Transplantation

Intervention Type PROCEDURE

Procedure: Fecal Microbiota Transplantation

Immune checkpoint inhibition-related colitis

Fecal Microbiota Transplantation will be performed.

Group Type EXPERIMENTAL

Fecal Microbiota Transplantation

Intervention Type PROCEDURE

Procedure: Fecal Microbiota Transplantation

Autoimmune enteropathy

Fecal Microbiota Transplantation will be performed.

Group Type EXPERIMENTAL

Fecal Microbiota Transplantation

Intervention Type PROCEDURE

Procedure: Fecal Microbiota Transplantation

Drug-induced diarrhea

Fecal Microbiota Transplantation will be performed.

Group Type EXPERIMENTAL

Fecal Microbiota Transplantation

Intervention Type PROCEDURE

Procedure: Fecal Microbiota Transplantation

Interventions

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Fecal Microbiota Transplantation

Procedure: Fecal Microbiota Transplantation

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guangzhou First People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hongli Huang, MM

Role: PRINCIPAL_INVESTIGATOR

Guangzhou First People's Hospital

Locations

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Guangzhou First People's Hospital

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yongjian Zhou, MM

Role: CONTACT

86-13503060150

Hongli Huang, MM

Role: CONTACT

86-13631316718

Facility Contacts

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Yongjian Zhou, MM

Role: primary

86-13503060150

Hongli Huang, MM

Role: backup

86-13631316718

References

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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.

Reference Type BACKGROUND
PMID: 28260787 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23318479 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28214091 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30403550 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30328245 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28586116 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29471030 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29100842 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31852769 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31258528 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31665575 (View on PubMed)

Other Identifiers

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B-2019-041-01

Identifier Type: -

Identifier Source: org_study_id

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