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

NCT06201182 | Recruiting

• 1 other identifier: MTU-EC-IM-1-080/63
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Irritable Bowel Syndrome

Keywords

Fecal microbiota transplantation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Quality of life score

  4 weeks, 12 weeks

• Adverse event

  4 weeks, 12 weeks

• Changes in microbiota diversity before and after FMT

  4 weeks

Study Arms (3)

FMT rectal enema

EXPERIMENTAL

Patients will receive FMT via rectal enema and placebo capsules.

Drug: FMT via rectal enema; Drug: Placebo capsules

Encapsulated FMT

EXPERIMENTAL

Patients will receive FMT capsules and placebo via rectal enema.

Drug: FMT capsules; Drug: Placebo via rectal enema

Placebo

PLACEBO COMPARATOR

Patients will receive placebo capsules and placebo via rectal enema.

Drug: Placebo via rectal enema; Drug: Placebo capsules

Interventions

FMT via rectal enema DRUG

50 grams of FMT via rectal enema

FMT rectal enema

FMT capsules DRUG

FMT capsules given twice daily for 2 consecutive days

Encapsulated FMT

Placebo via rectal enema DRUG

Placebo via rectal enema

Encapsulated FMT; Placebo

Placebo capsules DRUG

Placebo capsules given twice daily for 2 consecutive days

FMT rectal enema; Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18-70 years with IBS diagnosed by Rome IV criteria
• Patients who can provide written informed consent.

You may not qualify if:

• 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

Sponsors & Collaborators

• Thammasat University: lead

Study Sites (1)

Thammasat University

Pathum Thani, 12120, Thailand

RECRUITING

Related Publications (10)

• 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.

  PMID: 27144627 BACKGROUND

• 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.

  PMID: 28404070 BACKGROUND

• 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.

  PMID: 22730468 BACKGROUND

• 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.

  PMID: 28087657 BACKGROUND

• 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.

  PMID: 31852769 BACKGROUND

• 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.

  PMID: 32681922 BACKGROUND

• 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.

  PMID: 29100842 BACKGROUND

• 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.

  PMID: 29980607 BACKGROUND

• 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.

  PMID: 31326345 BACKGROUND

• Aumpan N, Chonprasertsuk S, Pornthisarn B, Siramolpiwat S, Bhanthumkomol P, Issariyakulkarn N, Gamnarai P, Bongkotvirawan P, Wongcha-Um A, Mahachai V, Vilaichone RK. Efficacy of encapsulated fecal microbiota transplantation and FMT via rectal enema for irritable bowel syndrome: a double-blind, randomized, placebo-controlled trial (CAP-ENEMA FMT Trial). Front Med (Lausanne). 2025 Sep 23;12:1648944. doi: 10.3389/fmed.2025.1648944. eCollection 2025.

  PMID: 41064515 DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Central Study Contacts

Natsuda Aumpan, MD

CONTACT

+66870494808; aumpan.natsuda@gmail.com

Ratha-korn Vilaichone, MD, PhD

CONTACT

+66891044488; vilaichone@hotmail.co.th

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Patients 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.

Study Record Dates

• First Submitted: December 30, 2023
• First Posted: January 11, 2024
• Study Start: August 19, 2020
• Primary Completion: August 19, 2024
• Study Completion: August 19, 2024
• Last Updated: April 15, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)