Efficacy and Safety of Fecal Microbiota Transplantation
NCT ID: NCT04706611
Last Updated: 2021-04-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
300 participants
INTERVENTIONAL
2021-01-15
2026-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Safety and Efficacy of Fecal Microbiota Transplantation in the Treatment of Digestive Diseases and Non-digestive System Diseases Associated With Gastrointestinal Symptoms in the Gastrointestinal Tract.
NCT06208930
Fecal Microbiota Transplantation for Irritable Bowel Syndrome
NCT03613545
Efficacy and Safety of FMT for the Treatment of IBS-D and Mental Health Comorbidity in Young Adults
NCT06297421
Efficacy and Safety Evaluation of Fecal Microbiota Transplantation in Irritable Bowel Syndrome
NCT05740319
Effect of Fecal Microbiota Transplantation (FMT) in Pediatric Functional Gastrointestinal Disorders
NCT05753774
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Irritable Bowel Syndrome
Fecal Microbiota Transplantation will be performed.
Fecal Microbiota Transplantation
Procedure: Fecal Microbiota Transplantation
Constipation
Fecal Microbiota Transplantation will be performed.
Fecal Microbiota Transplantation
Procedure: Fecal Microbiota Transplantation
Clostridium Difficile Infection
Fecal Microbiota Transplantation will be performed.
Fecal Microbiota Transplantation
Procedure: Fecal Microbiota Transplantation
Functional Dyspepsia
Fecal Microbiota Transplantation will be performed.
Fecal Microbiota Transplantation
Procedure: Fecal Microbiota Transplantation
Parkinson's Disease
Fecal Microbiota Transplantation will be performed.
Fecal Microbiota Transplantation
Procedure: Fecal Microbiota Transplantation
Metabolic Syndrome
Fecal Microbiota Transplantation will be performed.
Fecal Microbiota Transplantation
Procedure: Fecal Microbiota Transplantation
Non-Alcoholic Fatty Liver Disease
Fecal Microbiota Transplantation will be performed.
Fecal Microbiota Transplantation
Procedure: Fecal Microbiota Transplantation
Autism Spectrum Disorder
Fecal Microbiota Transplantation will be performed.
Fecal Microbiota Transplantation
Procedure: Fecal Microbiota Transplantation
Radiation Enteritis
Fecal Microbiota Transplantation will be performed.
Fecal Microbiota Transplantation
Procedure: Fecal Microbiota Transplantation
Atopic Dermatitis
Fecal Microbiota Transplantation will be performed.
Fecal Microbiota Transplantation
Procedure: Fecal Microbiota Transplantation
Food Allergic
Fecal Microbiota Transplantation will be performed.
Fecal Microbiota Transplantation
Procedure: Fecal Microbiota Transplantation
Graft-versus-Host Disease
Fecal Microbiota Transplantation will be performed.
Fecal Microbiota Transplantation
Procedure: Fecal Microbiota Transplantation
Obesity
Fecal Microbiota Transplantation will be performed.
Fecal Microbiota Transplantation
Procedure: Fecal Microbiota Transplantation
Diabetes mellitus
Fecal Microbiota Transplantation will be performed.
Fecal Microbiota Transplantation
Procedure: Fecal Microbiota Transplantation
Multi-Drug Resistant Infection
Fecal Microbiota Transplantation will be performed.
Fecal Microbiota Transplantation
Procedure: Fecal Microbiota Transplantation
Hepatic Encephalopathy
Fecal Microbiota Transplantation will be performed.
Fecal Microbiota Transplantation
Procedure: Fecal Microbiota Transplantation
Enteric Dysbacteriosis
Fecal Microbiota Transplantation will be performed.
Fecal Microbiota Transplantation
Procedure: Fecal Microbiota Transplantation
Multiple Sclerosis
Fecal Microbiota Transplantation will be performed.
Fecal Microbiota Transplantation
Procedure: Fecal Microbiota Transplantation
Pseudomembranous Enteritis
Fecal Microbiota Transplantation will be performed.
Fecal Microbiota Transplantation
Procedure: Fecal Microbiota Transplantation
Acute Pancreatitis
Fecal Microbiota Transplantation will be performed.
Fecal Microbiota Transplantation
Procedure: Fecal Microbiota Transplantation
Chronic Fatigue Syndrome
Fecal Microbiota Transplantation will be performed.
Fecal Microbiota Transplantation
Procedure: Fecal Microbiota Transplantation
Acute-on-chronic Liver Failure with HBV Infection
Fecal Microbiota Transplantation will be performed.
Fecal Microbiota Transplantation
Procedure: Fecal Microbiota Transplantation
Alcoholic Liver Disease
Fecal Microbiota Transplantation will be performed.
Fecal Microbiota Transplantation
Procedure: Fecal Microbiota Transplantation
Anorexia
Fecal Microbiota Transplantation will be performed.
Fecal Microbiota Transplantation
Procedure: Fecal Microbiota Transplantation
Decompensated Cirrhosis
Fecal Microbiota Transplantation will be performed.
Fecal Microbiota Transplantation
Procedure: Fecal Microbiota Transplantation
Henoch-Schonlein Purpura
Fecal Microbiota Transplantation will be performed.
Fecal Microbiota Transplantation
Procedure: Fecal Microbiota Transplantation
Autoimmune Liver Disease
Fecal Microbiota Transplantation will be performed.
Fecal Microbiota Transplantation
Procedure: Fecal Microbiota Transplantation
Systemic Lupus Erythematosus
Fecal Microbiota Transplantation will be performed.
Fecal Microbiota Transplantation
Procedure: Fecal Microbiota Transplantation
IgG4-Related Disease
Fecal Microbiota Transplantation will be performed.
Fecal Microbiota Transplantation
Procedure: Fecal Microbiota Transplantation
Celiac Disease
Fecal Microbiota Transplantation will be performed.
Fecal Microbiota Transplantation
Procedure: Fecal Microbiota Transplantation
Protein-losing Enteropathy
Fecal Microbiota Transplantation will be performed.
Fecal Microbiota Transplantation
Procedure: Fecal Microbiota Transplantation
Asperger Syndrome
Fecal Microbiota Transplantation will be performed.
Fecal Microbiota Transplantation
Procedure: Fecal Microbiota Transplantation
Rheumatoid arthritis
Fecal Microbiota Transplantation will be performed.
Fecal Microbiota Transplantation
Procedure: Fecal Microbiota Transplantation
Ulcerative colitis
Fecal Microbiota Transplantation will be performed.
Fecal Microbiota Transplantation
Procedure: Fecal Microbiota Transplantation
Crohn's disease
Fecal Microbiota Transplantation will be performed.
Fecal Microbiota Transplantation
Procedure: Fecal Microbiota Transplantation
Psoriasis
Fecal Microbiota Transplantation will be performed.
Fecal Microbiota Transplantation
Procedure: Fecal Microbiota Transplantation
Ankylosing spondylitis
Fecal Microbiota Transplantation will be performed.
Fecal Microbiota Transplantation
Procedure: Fecal Microbiota Transplantation
Immune checkpoint inhibition-related colitis
Fecal Microbiota Transplantation will be performed.
Fecal Microbiota Transplantation
Procedure: Fecal Microbiota Transplantation
Autoimmune enteropathy
Fecal Microbiota Transplantation will be performed.
Fecal Microbiota Transplantation
Procedure: Fecal Microbiota Transplantation
Drug-induced diarrhea
Fecal Microbiota Transplantation will be performed.
Fecal Microbiota Transplantation
Procedure: Fecal Microbiota Transplantation
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Fecal Microbiota Transplantation
Procedure: Fecal Microbiota Transplantation
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Guangzhou First People's Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Hongli Huang, MM
Role: PRINCIPAL_INVESTIGATOR
Guangzhou First People's Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Guangzhou First People's Hospital
Guangzhou, Guangdong, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
B-2019-041-01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.