Efficacy of Fecal Microbiota Transplantation (FMT) in Irritable Bowel Syndrome (IBS)
NCT ID: NCT06201182
Last Updated: 2024-04-15
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
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RECRUITING
NA
45 participants
INTERVENTIONAL
2020-08-19
2024-08-19
Brief Summary
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• 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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
* 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.
TREATMENT
TRIPLE
Study Groups
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FMT rectal enema
Patients will receive FMT via rectal enema and placebo capsules.
FMT via rectal enema
50 grams of FMT via rectal enema
Placebo capsules
Placebo capsules given twice daily for 2 consecutive days
Encapsulated FMT
Patients will receive FMT capsules and placebo via rectal enema.
FMT capsules
FMT capsules given twice daily for 2 consecutive days
Placebo via rectal enema
Placebo via rectal enema
Placebo
Patients will receive placebo capsules and placebo via rectal enema.
Placebo via rectal enema
Placebo via rectal enema
Placebo capsules
Placebo capsules given twice daily for 2 consecutive days
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Patients who can provide written informed consent.
Exclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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Thammasat University
OTHER
Responsible Party
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Natsuda Aumpan, MD
Principal Investigator
Locations
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Thammasat University
Pathum Thani, , Thailand
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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MTU-EC-IM-1-080/63
Identifier Type: -
Identifier Source: org_study_id
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