Effect of a Combination of Lactase and L. Salivarius DSM 34078 in Individuals With Lactose Intolerance

Exclusion Criteria

• •1. Self-reported known allergy or hypersensitivity to any components of the investigational products and/or chlorhexidine and/or standardised on-site meal
• •2. Self-reported congenital lactase deficiency (CLD)
• •3. Self-reported galactosemia
• •4. 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)
• •5. Self-reported inexplicable weight loss (\>5%) within the last 3 months prior to study
• •6. Pulmonary disease that may interfere with the HBT
• •7. Hospital Anxiety and Depression Scale (HADS) anxiety or depression score of ≥11 at V0
• •8. Patient Health Questionnaire for Somatization (PHQ-15) score ≥15 at V0
• •9. Self-reported history and/or presence of other clinically significant condition/disorder, which per investigator's judgement could interfere with the results of the study or the safety of the subject, e.g.:
• •1. uncontrolled thyroid gland disorder
• •2. uncontrolled hypertension
• •3. diabetes mellitus
• •4. immunodeficiency
• •5. scleroderma
• •6. any other relevant serious organ or systemic diseases (e.g. cardiovascular, liver, renal, malignant, psychiatric disease etc.)
• •10. Significant GI surgery (except cholecystectomy, appendectomy) within the last 6 months prior to or planned during the study
• •11. Smoking
• •12. Colonoscopy or colon cleaning procedure within the last 4 weeks prior to and during the study
• •13. Regular medication and/or supplementation within the last 4 weeks prior to and during the study:
• •1. antibiotics
• •2. probiotics
• •3. for management of LI complaints or any other that could influence gastrointestinal functions (e.g. laxatives (including fermentable dietary fibers), opioids, systemic corticosteroids, anticholinergics, anti-diarrheals, spasmolytics, prokinetics etc.) as per investigator judgement; intake of lactase prior to study is allowed
• •14. Clinically relevant deviation of safety laboratory parameter(s) at V0
• •15. Women of child-bearing potential: pregnancy or nursing
• •16. History of or current abuse of drugs, alcohol or medication
• •17. Participation in another study during the last 30 days prior to and during the study
• •18. Any other reason for exclusion as per investigator's judgment, e.g. insufficient compliance with study procedures