Clinical Trial

The Role of Irritable Bowel Syndrome in Lactose Intolerance (LION)

Study acronym: LION
Not Yet Recruiting
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Summary
Irritable bowel syndrome (IBS) is a functional gastrointestinal disease. There is no well-defined pharmacological treatment. This clinical trial is a prospective, double-blind, two-armed randomized controlled, single-center trial. It is created to examine the role of IBS in patients with lactose intolerance. IBS patients undergo lactose H2 breath test (LHBT) and lactose tolerance test (LTT). Those with positive LTT and LHBT will be randomized into two groups: alverine-citrate + simethicone and lactase group (1) or alverin-citrate + simethicone with the placebo group (2). The goal of this study is to compare the lactase enzyme with placebo in IBS patients with lactose intolerance.
Trial Details
NCT Number NCT05100719
Lead Sponsor University of Pecs
Conditions Irritable Bowel Syndrome, Lactose Intolerance, Lactose Malabsorption
Enrollment 200 participants
Start Date 2022-09
Primary Completion 2026-09 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2021-10-29