Status:
COMPLETED
Effect of a Combination of Lactase and L. Salivarius DSM 34078 in Individuals With Lactose Intolerance
Lead Sponsor:
Novozymes A/S
Collaborating Sponsors:
Analyze & Realize
Conditions:
Lactose Intolerance
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 ga...
Detailed Description
Participants will attend 3 visits (V0, V1, V2). Visit 0 is a screening/baseline visit (5 to 10 days before Visit 1), where participants will be checked for inclusion and exclusion criteria, and underg...
Eligibility Criteria
Inclusion
- Men and women from 18 to 65 years old
- Self-reported:
- previously diagnosed lactose intolerance or
- presumed lactose intolerance, defined as GI complaints upon intake of lactose-containing food/beverage (such as abdominal pain, distension, bloating, flatulence, nausea, diarrhea), when no lactase or lactase-containing product has been used by the subject
- 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
- to avoid the use of other products which may influence the GI complaints during the study
- to avoid the use of lactase during the study
- to complete the subject diary and study questionnaires (including the questions that require the use of the Visual Analogue Scale (VAS))
- Women of childbearing potential:
- commitment to use appropriate contraception methods
- negative pregnancy testing (beta human chorionic gonadotropin test in urine)
- Readiness not to participate in another clinical study during this study
- Participation is based upon written informed consent by the participant following written and oral information by the investigator regarding nature, purpose, consequences and possible risks of the clinical study.
Exclusion
- Self-reported known allergy or hypersensitivity to any components of the investigational products and/or chlorhexidine and/or standardised on-site meal
- Self-reported congenital lactase deficiency (CLD)
- Self-reported galactosemia
- 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)
- Self-reported inexplicable weight loss (\>5%) within the last 3 months prior to study
- Pulmonary disease that may interfere with the HBT
- Hospital Anxiety and Depression Scale (HADS) anxiety or depression score of ≥11 at V0
- Patient Health Questionnaire for Somatization (PHQ-15) score ≥15 at V0
- 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.:
- uncontrolled thyroid gland disorder
- uncontrolled hypertension
- diabetes mellitus
- immunodeficiency
- scleroderma
- any other relevant serious organ or systemic diseases (e.g. cardiovascular, liver, renal, malignant, psychiatric disease etc.)
- Significant GI surgery (except cholecystectomy, appendectomy) within the last 6 months prior to or planned during the study
- Smoking
- Colonoscopy or colon cleaning procedure within the last 4 weeks prior to and during the study
- Regular medication and/or supplementation within the last 4 weeks prior to and during the study:
- antibiotics
- probiotics
- 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
- Clinically relevant deviation of safety laboratory parameter(s) at V0
- Women of child-bearing potential: pregnancy or nursing
- History of or current abuse of drugs, alcohol or medication
- Participation in another study during the last 30 days prior to and during the study
- Any other reason for exclusion as per investigator's judgment, e.g. insufficient compliance with study procedures
Key Trial Info
Start Date :
November 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 10 2024
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT06107088
Start Date
November 20 2023
End Date
July 10 2024
Last Update
July 16 2024
Active Locations (1)
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1
Analyze & Realize Study Center
Berlin, Germany