Effect of a Combination of Lactase and L. Salivarius DSM 34078 in Individuals With Lactose Intole… (NCT06107088) | Clinical Trial Compass
CompletedNot Applicable
Effect of a Combination of Lactase and L. Salivarius DSM 34078 in Individuals With Lactose Intolerance
Germany76 participantsStarted 2023-11-20
Plain-language summary
The goal of this clinical trial is to test whether a new combination of lactase and bacterial strain (L. Salivarius DSM 34078) can provide longer lasting beneficial effects on lactose digestion and gastrointestinal symptoms compared to lactase alone in people with lactose intolerance.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Men and women from 18 to 65 years old
✓. Self-reported:
✓. Lactose maldigestion, confirmed by hydrogen breath test during lactose challenge at V0 (increase in H2 concentration of ≥ 20 parts per million (ppm) compared to value at t=0, during first 3 hours upon challenge)
✓. Generally in good health as per investigator's judgement
✓. Subject's ability and agreement to comply with study procedures, in particular:
✓. to adhere to conditions prior to test days
✓. keep the habitual dietary habits and physical activity (except with regard to conditions prior to test days); however, the consumption of lactose-containing products between V1 and V2 should be encouraged
✓. to complete study visits as required
Exclusion criteria
✕. Self-reported known allergy or hypersensitivity to any components of the investigational products and/or chlorhexidine and/or standardised on-site meal
✕. Self-reported history and/or presence of relevant GI disease or digestion/absorption disorder (e.g. inflammatory bowel disease, coeliac disease, gastroenteritis, severe constipation etc.) except for irritable bowel syndrome ((IBS); this condition is acceptable)
What they're measuring
1
Difference in change in concentration of breath hydrogen between Test product1 and Comparator at the second lactose challenge of Visit 2, compared to baseline (Visit 0)
Timeframe: one week
2
Difference in change in concentration of breath hydrogen between Test product2 and Comparator at the second lactose challenge of Visit 2, compared to baseline (Visit 0)