Rifaximin Treatment in Bloating Predominant Functional Bowel Disorders

Summary

This randomized, double-blind, placebo-controlled trial will evaluate whether a 14-day course of rifaximin improves bloating in adult patients with Rome IV functional bowel disorders in whom bloating is the predominant symptom. Eligible participants with irritable bowel syndrome, functional constipation, or functional abdominal bloating/distension and bothersome bloating despite adequate bowel movement management will be assigned in a 1:1 ratio to rifaximin 550 mg three times daily or matching placebo for 2 weeks. The primary endpoint is the proportion of participants with bloating response, defined as at least a 1-point reduction from baseline in a 7-point Likert bloating score at the end of treatment.

Timeline

Start

2026-04

Primary completion

2027-10

Completion

2027-12

Publications

• Background 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.
• Background Lacy BE, Chang L, Rao SSC, Heimanson Z, Sayuk GS. Rifaximin Treatment for Individual and Multiple Symptoms of Irritable Bowel Syndrome With Diarrhea: An Analysis Using New End Points. Clin Ther. 2023 Mar;45(3):198-209. doi: 10.1016/j.clinthera.2023.01.010. Epub 2023 Mar 14.
• Background Chey WD, Shah ED, DuPont HL. Mechanism of action and therapeutic benefit of rifaximin in patients with irritable bowel syndrome: a narrative review. Ther Adv Gastroenterol. 2020 Jan 23;13:1756284819897531. doi: 10.1177/1756284819897531. eCollection 2020.
• Background Melchior C, Hammer H, Bor S, Barba E, Horvat IB, Celebi A, Drug V, Dumitrascu D, Kalkan IH, Hauser G, Lionis C, Livovsky D, Mari A, Mulak A, Surdea-Blaga T, Tack J, Vanuytsel T, Savarino EV, Zarate-Lopez N, Hammer J, Dickman R. European Consensus on Functional Bloating and Abdominal Distension-An ESNM/UEG Recommendations for Clinical Management. United European Gastroenterol J. 2025 Nov;13(9):1613-1651. doi: 10.1002/ueg2.70098. Epub 2025 Aug 22.
• Background Moshiree B, Drossman D, Shaukat A. AGA Clinical Practice Update on Evaluation and Management of Belching, Abdominal Bloating, and Distention: Expert Review. Gastroenterology. 2023 Sep;165(3):791-800.e3. doi: 10.1053/j.gastro.2023.04.039. Epub 2023 Jul 13.
• Background Arora U, Sachdeva K, Garg P, Baitha U, Kedia S, Kalaivani M, Ahuja V, Kumar A, Ranjan P, Vikram NK, Sinha S, Biswas A, Wig N. Efficacy of Rifaximin in Patients With Abdominal Bloating or Distension: A Systematic Review and Meta-analysis. J Clin Gastroenterol. 2024 Apr 1;58(4):360-369. doi: 10.1097/MCG.0000000000001872.

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Indications