Efficacy of Fecal Microbiota Transplantation (FMT) in Irritable Bowel Syndrome (IBS)

Irritable Bowel Syndrome Clinical Trial

Official title:

Efficacy of Fecal Microbiota Transplantation (FMT) in Irritable Bowel Syndrome (IBS): A Randomized, Placebo-controlled, Double-blind Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06201182
• Other study ID #: MTU-EC-IM-1-080/63
• Status: Recruiting
• Phase: N/A
• Start date: August 19, 2020
• Est. completion date: August 19, 2024

Study information

• Verified date: April 2024
• Source: Thammasat University
• Contact: Natsuda Aumpan, MD
• Phone: +66870494808
• Email: aumpan.natsuda[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to determine efficacy of FMT via rectal enema and encapsulated FMT in patients with IBS in Thailand. The main question it aims to answer is:

• Does FMT provide better efficacy than placebo in IBS patients?

Participants will be randomized into 3 groups:

• In placebo group, patients will receive placebo capsules and placebo via enema.

• In enema group, patients will receive placebo capsules and FMT via rectal enema.

• In capsule group, patients will receive FMT capsules and placebo via rectal enema.

Researchers will compare FMT and placebo group to see if using FMT provides better efficacy for IBS patients than placebo. Moreover, researchers will compare efficacy of FMT capsules and FMT via rectal enema in IBS patients.

Description:

Irritable bowel syndrome (IBS) is a common functional bowel disorder defined by recurrent abdominal pain related to defecation or a change in bowel habit (1). Pathogenic mechanisms of IBS include gut microbial dysbiosis, low-grade mucosal inflammation, increased gut permeability, and altered gut-brain interaction (2). Dysbiosis is an imbalance of gut microbiota which can contribute to IBS. Emerging treatment approach for IBS aims to correct dysbiosis by modulation of intestinal microbiota (3).

Fecal microbiota transplantation (FMT) is an administration of feces from a healthy donor to the gastrointestinal tract of a recipient in order to restore balanced microbial flora (4). Correcting gut dysbiosis might be another target to improve IBS symptoms. Some previous randomized controlled trials demonstrated that FMT could provide clinical response in patients with IBS (5-7), whereas others reported no different outcome from placebo (8, 9). Most trials delivered FMT via more invasive routes such as colonoscopy or gastroscopy. There were few studies using less invasive methods, e.g., oral FMT capsules and FMT via rectal enema. Less invasive routes of FMT administration are needed to be evaluated so as to reduce risk and cost of endoscopy.

This study aimed to determine efficacy of FMT via rectal enema and encapsulated FMT compared with placebo in IBS patients in Thailand.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: August 19, 2024
• Est. primary completion date: August 19, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients aged 18-70 years with IBS diagnosed by Rome IV criteria

• Patients who can provide written informed consent.

Exclusion Criteria:

• Pregnant or breastfeeding women

• Severe comorbidities: chronic kidney disease (GFR<15 ml/min), cirrhosis, cancer, etc.

• Fecal incontinence

• Immunocompromised patients

• Taking probiotic, or fermented food

• Discontinue medication for IBS <1 month prior to study inclusion

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

Drug:
• FMT via rectal enema
50 grams of FMT via rectal enema
• FMT capsules
FMT capsules given twice daily for 2 consecutive days
• Placebo via rectal enema
Placebo via rectal enema
• Placebo capsules
Placebo capsules given twice daily for 2 consecutive days

Locations

Country	Name	City	State
Thailand	Thammasat University	Pathumthani

Sponsors (1)

Lead Sponsor	Collaborator
Thammasat University

Country where clinical trial is conducted

Thailand, 

References & Publications (9)

Aroniadis OC, Brandt LJ, Oneto C, Feuerstadt P, Sherman A, Wolkoff AW, Kassam Z, Sadovsky RG, Elliott RJ, Budree S, Kim M, Keller MJ. Faecal microbiota transplantation for diarrhoea-predominant irritable bowel syndrome: a double-blind, randomised, placebo-controlled trial. Lancet Gastroenterol Hepatol. 2019 Sep;4(9):675-685. doi: 10.1016/S2468-1253(19)30198-0. Epub 2019 Jul 17. — View Citation

Cammarota G, Ianiro G, Tilg H, Rajilic-Stojanovic M, Kump P, Satokari R, Sokol H, Arkkila P, Pintus C, Hart A, Segal J, Aloi M, Masucci L, Molinaro A, Scaldaferri F, Gasbarrini G, Lopez-Sanroman A, Link A, de Groot P, de Vos WM, Hogenauer C, Malfertheiner P, Mattila E, Milosavljevic T, Nieuwdorp M, Sanguinetti M, Simren M, Gasbarrini A; European FMT Working Group. European consensus conference on faecal microbiota transplantation in clinical practice. Gut. 2017 Apr;66(4):569-580. doi: 10.1136/gutjnl-2016-313017. Epub 2017 Jan 13. — View Citation

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. — View Citation

Halkjaer SI, Christensen AH, Lo BZS, Browne PD, Gunther S, Hansen LH, Petersen AM. Faecal microbiota transplantation alters gut microbiota in patients with irritable bowel syndrome: results from a randomised, double-blind placebo-controlled study. Gut. 2018 Dec;67(12):2107-2115. doi: 10.1136/gutjnl-2018-316434. Epub 2018 Jul 6. — View Citation

Holtmann GJ, Ford AC, Talley NJ. Pathophysiology of irritable bowel syndrome. Lancet Gastroenterol Hepatol. 2016 Oct;1(2):133-146. doi: 10.1016/S2468-1253(16)30023-1. Epub 2016 Sep 8. — View Citation

Holvoet T, Joossens M, Vazquez-Castellanos JF, Christiaens E, Heyerick L, Boelens J, Verhasselt B, van Vlierberghe H, De Vos M, Raes J, De Looze D. Fecal Microbiota Transplantation Reduces Symptoms in Some Patients With Irritable Bowel Syndrome With Predominant Abdominal Bloating: Short- and Long-term Results From a Placebo-Controlled Randomized Trial. Gastroenterology. 2021 Jan;160(1):145-157.e8. doi: 10.1053/j.gastro.2020.07.013. Epub 2020 Jul 15. — View Citation

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. — View Citation

Mearin F, Lacy BE, Chang L, Chey WD, Lembo AJ, Simren M, Spiller R. Bowel Disorders. Gastroenterology. 2016 Feb 18:S0016-5085(16)00222-5. doi: 10.1053/j.gastro.2016.02.031. Online ahead of print. — View Citation

Simren M, Barbara G, Flint HJ, Spiegel BM, Spiller RC, Vanner S, Verdu EF, Whorwell PJ, Zoetendal EG; Rome Foundation Committee. Intestinal microbiota in functional bowel disorders: a Rome foundation report. Gut. 2013 Jan;62(1):159-76. doi: 10.1136/gutjnl-2012-302167. Epub 2012 Jun 22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of responders	Response is defined as a decrease in IBS-symptom severity score (IBS-SSS) more than 50 points from baseline.	4 weeks, 12 weeks
Secondary	Quality of life score	Quality of life score will be assessed in both FMT and placebo groups	4 weeks, 12 weeks
Secondary	Adverse event	Record adverse events during and after treatment	4 weeks, 12 weeks
Secondary	Changes in microbiota diversity before and after FMT	Evaluate changes in microbiota diversity before and after FMT	4 weeks