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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Irritable Bowel Syndrome
• Intervention / Treatment: Drug: FMT via rectal enema; Drug: Placebo capsules; Drug: FMT capsules; Drug: Placebo via rectal enema

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Natsuda Aumpan, MD; Phone Number: +66870494808; Email: aumpan.natsuda@gmail.com
• Study Contact Backup: Name: Ratha-korn Vilaichone, MD, PhD; Phone Number: +66891044488; Email: vilaichone@hotmail.co.th

Study Locations

• Thailand
  • Pathumthani, Thailand, 12120
    • Recruiting
    • Thammasat University
    • Contact: Natsuda Aumpan, MD; Phone Number: +66870494808; Email: aumpan.natsuda@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FMT rectal enema; Patients will receive FMT via rectal enema and placebo capsules.	Drug: FMT via rectal enema; 50 grams of FMT via rectal enema; Drug: Placebo capsules; Placebo capsules given twice daily for 2 consecutive days
Experimental: Encapsulated FMT; Patients will receive FMT capsules and placebo via rectal enema.	Drug: FMT capsules; FMT capsules given twice daily for 2 consecutive days; Drug: Placebo via rectal enema; Placebo via rectal enema
Placebo Comparator: Placebo; Patients will receive placebo capsules and placebo via rectal enema.	Drug: Placebo capsules; Placebo capsules given twice daily for 2 consecutive days; Drug: Placebo via rectal enema; Placebo via rectal enema

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse event	Record adverse events during and after treatment	4 weeks, 12 weeks
Changes in microbiota diversity before and after FMT	Evaluate changes in microbiota diversity before and after FMT	4 weeks
Quality of life score	Quality of life score will be assessed in both FMT and placebo groups	4 weeks, 12 weeks

Collaborators and Investigators

• Sponsor: Thammasat University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2020
• Primary Completion (Estimated): August 19, 2024
• Study Completion (Estimated): August 19, 2024

Study Registration Dates

• First Submitted: December 30, 2023
• First Submitted That Met QC Criteria: December 30, 2023
• First Posted (Actual): January 11, 2024

Study Record Updates

• Last Update Posted (Estimated): April 15, 2024
• Last Update Submitted That Met QC Criteria: April 12, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Fecal microbiota transplantation
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome
• Other Study ID Numbers: MTU-EC-IM-1-080/63

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No