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

NCT05100719 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2021-10-29

No results posted yet for this study

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.

Conditions

  • Irritable Bowel Syndrome
  • Lactose Intolerance
  • Lactose Malabsorption

Interventions

DRUG

alverine-citrate + simethicone and lactase

Patients who randomized in the first arm are treated with alverine-citrate + simethicone and lactase.

DRUG

alverin-citrate + simethicone with placebo

Patients in the second arm receive alverin-citrate + simethicone with placebo without lactase.

Sponsors & Collaborators

  • University of Pecs

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-30
Primary Completion
2026-09-30
Completion
2026-12-31

Countries

  • Hungary

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05100719 on ClinicalTrials.gov