The Role of Irritable Bowel Syndrome in Lactose Intolerance (LION)
NCT ID: NCT05100719
Last Updated: 2021-10-29
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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NOT_YET_RECRUITING
NA
200 participants
INTERVENTIONAL
2022-09-30
2026-12-31
Brief Summary
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Detailed Description
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There are no studies that assess the link between lactose intolerance and IBS. Our primary objective is the examination of the relationship between lactose intolerance and IBS with or without the replacement of lactase enzyme. Our secondary objectives are to compare the lactase/beta-galactosidase enzyme replacement with placebo with the evaluation of a TSS (Total symptom score), VAS (Visual Analog Scale), QoL (Quality of life) questionnaires. The other secondary outcomes are to compare the severity of baseline symptoms during and after lactose administration.
Patients diagnosed with IBS according to the Rome IV criteria will test with LTT and LHBT.
Who has positive LTT and LHBT will randomize into two groups: (1) alverine-citrate + simethicone and lactase; (2) alverin-citrate + simethicone with placebo.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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alverine-citrate + simethicone and lactase
Patients diagnosed with irritable bowel syndrome based on the ROME IV criteria will go through a lactase intolerance test (LTT) and (lactose H2 breath test) LHBT. Those who have positive LTT and LHBT will receive alverine-citrate + simethicone and lactase.
alverine-citrate + simethicone and lactase
Patients who randomized in the first arm are treated with alverine-citrate + simethicone and lactase.
alverin-citrate + simethicone with placebo
Patients diagnosed with irritable bowel syndrome based on the ROME IV criteria will go through a lactase intolerance test (LTT) and (lactose H2 breath test) LHBT. Those who have positive LTT and LHBT will receive alverine-citrate + simethicone with placebo.
alverin-citrate + simethicone with placebo
Patients in the second arm receive alverin-citrate + simethicone with placebo without lactase.
Interventions
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alverine-citrate + simethicone and lactase
Patients who randomized in the first arm are treated with alverine-citrate + simethicone and lactase.
alverin-citrate + simethicone with placebo
Patients in the second arm receive alverin-citrate + simethicone with placebo without lactase.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* patients diagnosed with irritable bowel syndrome based on the ROME IV. criteria
* positive LHBT (lactose H2 breath test) and LTT (lactose tolerance test) results
* negative abdominal ultrasound/CAT scan/MRI results within one year
* signed the informed consent
Exclusion Criteria
* Alarm symptoms: fever (\> 38 Co), anaemia (Hgb \< 120 g/l), unintended weight loss (\> 4.5 kg / 3 months), gastrointestinal bleeding (hematemesis, hematochesia, melena)
* cardiac failure (NYHA III-IV)
* liver cirrhosis (Child-Pugh C)
* active malignancy
* major abdominal surgery in the history
* pregnant or breastfeeding women
* any circumstances which can lead to false results of LHBT and LTT: cigarette smoking or physical exercise within 2 hours before the test, ingestion of dietary fibers on the evening before the test, recent use of antibiotics, lung disease, baseline H2 concentration in the exhaled air is higher than 20 ppm, not properly treated diabetes mellitus, following lactose restricted or another special diet within 1 week prior to study enrolment (ingestion of less than 12 g lactose - less than 250 ml milk - per day)
* small intestinal bacterial overgrowth (SIBO): if there is a rapid increase of H2 level in the exhaled air (≥20 ppm above baseline within 90 minutes), SIBO is suspected and antibiotic therapy will be started (peroral rifaximin for 5 days) after negative Helicobacter pylori serology. After this procedure, lactulose H2 breath test will be performed to exclude SIBO (≥20 ppm H2 rise only after 90 min). In case of negative lactulose H2 breath test, another LHBT will be carried out
* slow oro-cecal transit: clinical signs and typical findings on the tests (the LHBT is normal, but the increase of blood glucose level is less than 1.1 mmol/l and/or no H2 rise during lactulose H2 breath test)
* milk allergy (positive IgE test)
18 Years
80 Years
ALL
No
Sponsors
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University of Pecs
OTHER
Responsible Party
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József Czimmer
Divison of Gastroenterology, First Department of Medicine, Medical School, University of Pécs, Pécs, Hungary
Locations
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Institute for Translational Medicine, University of Pécs
Pécs, , Hungary
Countries
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References
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Related Links
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LION is designed and coordinated by the Centre for Translational Medicine (Medical School, University of Pécs). This link redirects to the official website of the institute.
Other Identifiers
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IV/4455-3/2021/EKU
Identifier Type: -
Identifier Source: org_study_id