Efficacy and Safety of Fecal Microbiota Transplantation

Fecal Microbiota Transplantation Clinical Trial

— FMT  

Official title:

Efficacy and Safety of Fecal Microbiota Transplantation in Patients With Intestinal Dysbiosis -A Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04706611
• Other study ID #: B-2019-041-01
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2021
• Est. completion date: December 31, 2026

Study information

• Verified date: February 2021
• Source: Guangzhou First People's Hospital
• Contact: Yongjian Zhou, MM
• Phone: 86-13503060150
• Email: eyzhouyongjian[@]scut.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fecal Microbiota Transplantation

Intervention

Procedure:
• Fecal Microbiota Transplantation
Procedure: Fecal Microbiota Transplantation

Locations

Country	Name	City	State
China	Guangzhou First People's Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou First People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (11)

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. — View Citation

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. — View Citation

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. — View Citation

El-Salhy M, Hatlebakk JG, Gilja OH, Bråthen 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. — View Citation

Johnsen PH, Hilpüsch 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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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-a signaling pathway. Brain Behav Immun. 2018 May;70:48-60. doi: 10.1016/j.bbi.2018.02.005. Epub 2018 Feb 20. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Numbers of patients who have improvement in clinical symptoms (depends on each disease as stated in outcome)		1 year
Primary	The efficacy of FMT in patients with gastrointestinal symptom will be assessed by the change of Gastrointestinal Symptom Rating Scale(GSRS).	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.	1 year
Secondary	Number of Participants With Treatment-Related Adverse Events as Assessed by Common Terminology Criteria for Adverse Events(CTCAE) V4.0		1 year