Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NOZ-DK/021121 | Other Identifier | analyze & realize |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Analyze & Realize | NETWORK |
Not provided
Not provided
Not provided
Not provided
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.
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 undergo a lactose challenge (drink a cup of lactose containing water) followed by a hydrogen breath test (HBT) and Carbohydrate Perception Questionnaire (CPQ) measured at intervals over 3 hours. At Visit 1, eligible participants are randomized into one of the four study arms: Lactase and bacterial strain combination in a capsule; lactase and bacterial strain combination in separate capsules, lactase only, or placebo. Each Visit 1 and Visit 2 takes about 8 hours, where participants take the investigational product (IP) before the first lactose challenge (with first HBT and first CPQ for 3 hours), followed by a 2-hour break with standardized meal provided, and undergo a second lactose challenge (with second HBT and second CPQ for another 3 hours). Visit 2 is scheduled one week after Visit 1, where participants take the IP once daily at home for a week and fill in a diary between Visit 1 and 2. Stool samples are collected at Visit 1 and 2.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test product1 | Experimental | 1 capsule 'lactase-bacterial strain combination' and 1 capsule placebo, once a day, one week |
|
| Test product2 | Experimental | 1 capsule lactase and 1 capsule bacterial strain, once a day, one week |
|
| Comparator | Active Comparator | 1 capsule lactase and 1 capsule placebo, once a day, one week |
|
| Placebo | Placebo Comparator | 2 capsules placebo, once a day, one week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active 1 | Dietary Supplement | lactase enzyme |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Change in the hydrogen concentration in the breath after lactose challenge is measured as incremental area under the curve (iAUC) for a period of 180 minutes | one week |
| 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) | Change in the hydrogen concentration in the breath after lactose challenge is measured as incremental area under the curve (iAUC) for a period of 180 minutes | one week |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in change in concentration of breath hydrogen between Test product1 and Placebo at the second lactose challenge of Visit 2, compared to baseline (Visit 0) | Change in the hydrogen concentration in the breath after lactose challenge is measured as incremental area under the curve (iAUC) for a period of 180 minutes | one week |
Not provided
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:
Women of childbearing potential:
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 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 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.:
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:
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Liana Vismane, MD | analyze & realize GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Analyze & Realize Study Center | Berlin | Germany |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007787 | Lactose Intolerance |
| ID | Term |
|---|---|
| D008286 | Malabsorption Syndromes |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Active 2 |
| Dietary Supplement |
lactase-bacterial strain combination |
|
| Active 3 | Dietary Supplement | bacterial strain alone |
|
| Placebo | Dietary Supplement | placebo |
|
| Difference in change in concentration of breath hydrogen between Test product2 and Placebo at the second lactose challenge of Visit 2, compared to baseline (Visit 0) |
Change in the hydrogen concentration in the breath after lactose challenge is measured as incremental area under the curve (iAUC) for a period of 180 minutes |
| one week |
| Difference in change in concentration of breath hydrogen between Test product1 and Comparator at the second lactose challenge of Visit 1, compared to baseline (Visit 0) | Change in the hydrogen concentration in the breath after lactose challenge is measured as incremental area under the curve (iAUC) for a period of 180 minutes | Day 1 |
| Difference in change in concentration of breath hydrogen between Test product2 and Comparator at the second lactose challenge of Visit 1, compared to baseline (Visit 0) | Change in the hydrogen concentration in the breath after lactose challenge is measured as incremental area under the curve (iAUC) for a period of 180 minutes | Day 1 |
| Difference in change in concentration of breath hydrogen between Test product1 and Placebo at the second lactose challenge of Visit 1, compared to baseline (Visit 0) | Change in the hydrogen concentration in the breath after lactose challenge is measured as incremental area under the curve (iAUC) for a period of 180 minutes | Day 1 |
| Difference in change in concentration of breath hydrogen between Test product2 and Placebo at the second lactose challenge of Visit 1, compared to baseline (Visit 0) | Change in the hydrogen concentration in the breath after lactose challenge is measured as incremental area under the curve (iAUC) for a period of 180 minutes | Day 1 |
| Difference in change in concentration of breath hydrogen between Test product1 and Comparator at the first lactose challenge of Visit 2, compared to baseline (Visit 0) | Change in the hydrogen concentration in the breath after lactose challenge is measured as incremental area under the curve (iAUC) for a period of 180 minutes | one week |
| Difference in change in concentration of breath hydrogen between Test product2 and Comparator at the first lactose challenge of Visit 2, compared to baseline (Visit 0) | Change in the hydrogen concentration in the breath after lactose challenge is measured as incremental area under the curve (iAUC) for a period of 180 minutes | one week |
| Difference in change in concentration of breath hydrogen between Test product1 and Placebo at the first lactose challenge of Visit 2, compared to baseline (Visit 0) | Change in the hydrogen concentration in the breath after lactose challenge is measured as incremental area under the curve (iAUC) for a period of 180 minutes | one week |
| Difference in change in concentration of breath hydrogen between Test product2 and Placebo at the first lactose challenge of Visit 2, compared to baseline (Visit 0) | Change in the hydrogen concentration in the breath after lactose challenge is measured as incremental area under the curve (iAUC) for a period of 180 minutes | one week |
| Difference in change in concentration of breath hydrogen between Test product1 and Comparator at the first lactose challenge of Visit 1, compared to baseline (Visit 0) | Change in the hydrogen concentration in the breath after lactose challenge is measured as incremental area under the curve (iAUC) for a period of 180 minutes | Day 1 |
| Difference in change in concentration of breath hydrogen between Test product2 and Comparator at the first lactose challenge of Visit 1, compared to baseline (Visit 0) | Change in the hydrogen concentration in the breath after lactose challenge is measured as incremental area under the curve (iAUC) for a period of 180 minutes | Day 1 |
| Difference in change in concentration of breath hydrogen between Test product1 and Placebo at the first lactose challenge of Visit 1, compared to baseline (Visit 0) | Change in the hydrogen concentration in the breath after lactose challenge is measured as incremental area under the curve (iAUC) for a period of 180 minutes | Day 1 |
| Difference in change in concentration of breath hydrogen between Test product2 and Placebo at the first lactose challenge of Visit 1, compared to baseline (Visit 0) | Change in the hydrogen concentration in the breath after lactose challenge is measured as incremental area under the curve (iAUC) for a period of 180 minutes | Day 1 |
| Difference in change in global score of Carbohydrate Perception Questionnaire (CPQ) between Test product1 and Comparator at the second lactose challenge of Visit 2, compared to baseline (Visit 0) | Global score of CPQ is calculated as the sum of individual gastrointestinal symptom score of pain, bloating, flatulence, nausea and diarrhoea, each of which is defined as score of change from the time point 0 min to the time point with the maximal value during the period of 180 min after a lactose challenge | one week |
| Difference in change in global score of Carbohydrate Perception Questionnaire (CPQ) between Test product2 and Comparator at the second lactose challenge of Visit 2, compared to baseline (Visit 0) | Global score of CPQ is calculated as the sum of individual gastrointestinal symptom score of pain, bloating, flatulence, nausea and diarrhoea, each of which is defined as score of change from the time point 0 min to the time point with the maximal value during the period of 180 min after a lactose challenge | one week |
| Difference in change in global score of Carbohydrate Perception Questionnaire (CPQ) between Test product1 and Placebo at the second lactose challenge of Visit 2, compared to baseline (Visit 0) | Global score of CPQ is calculated as the sum of individual gastrointestinal symptom score of pain, bloating, flatulence, nausea and diarrhoea, each of which is defined as score of change from the time point 0 min to the time point with the maximal value during the period of 180 min after a lactose challenge | one week |
| Difference in change in global score of Carbohydrate Perception Questionnaire (CPQ) between Test product2 and Placebo at the second lactose challenge of Visit 2, compared to baseline (Visit 0) | Global score of CPQ is calculated as the sum of individual gastrointestinal symptom score of pain, bloating, flatulence, nausea and diarrhoea, each of which is defined as score of change from the time point 0 min to the time point with the maximal value during the period of 180 min after a lactose challenge | one week |
| Difference in change in global score of Carbohydrate Perception Questionnaire (CPQ) between Test product1 and Comparator at the second lactose challenge of Visit 1, compared to baseline (Visit 0) | Global score of CPQ is calculated as the sum of individual gastrointestinal symptom score of pain, bloating, flatulence, nausea and diarrhoea, each of which is defined as score of change from the time point 0 min to the time point with the maximal value during the period of 180 min after a lactose challenge | Day 1 |
| Difference in change in global score of Carbohydrate Perception Questionnaire (CPQ) between Test product2 and Comparator at the second lactose challenge of Visit 1, compared to baseline (Visit 0) | Global score of CPQ is calculated as the sum of individual gastrointestinal symptom score of pain, bloating, flatulence, nausea and diarrhoea, each of which is defined as score of change from the time point 0 min to the time point with the maximal value during the period of 180 min after a lactose challenge | Day 1 |
| Difference in change in global score of Carbohydrate Perception Questionnaire (CPQ) between Test product1 and Placebo at the second lactose challenge of Visit 1, compared to baseline (Visit 0) | Global score of CPQ is calculated as the sum of individual gastrointestinal symptom score of pain, bloating, flatulence, nausea and diarrhoea, each of which is defined as score of change from the time point 0 min to the time point with the maximal value during the period of 180 min after a lactose challenge | Day 1 |
| Difference in change in global score of Carbohydrate Perception Questionnaire (CPQ) between Test product2 and Placebo at the second lactose challenge of Visit 1, compared to baseline (Visit 0) | Global score of CPQ is calculated as the sum of individual gastrointestinal symptom score of pain, bloating, flatulence, nausea and diarrhoea, each of which is defined as score of change from the time point 0 min to the time point with the maximal value during the period of 180 min after a lactose challenge | Day 1 |
| Difference in change in global score of Carbohydrate Perception Questionnaire (CPQ) between Test product1 and Comparator at the first lactose challenge of Visit 2, compared to baseline (Visit 0) | Global score of CPQ is calculated as the sum of individual gastrointestinal symptom score of pain, bloating, flatulence, nausea and diarrhoea, each of which is defined as score of change from the time point 0 min to the time point with the maximal value during the period of 180 min after a lactose challenge | one week |
| Difference in change in global score of Carbohydrate Perception Questionnaire (CPQ) between Test product2 and Comparator at the first lactose challenge of Visit 2, compared to baseline (Visit 0) | Global score of CPQ is calculated as the sum of individual gastrointestinal symptom score of pain, bloating, flatulence, nausea and diarrhoea, each of which is defined as score of change from the time point 0 min to the time point with the maximal value during the period of 180 min after a lactose challenge | one week |
| Difference in change in global score of Carbohydrate Perception Questionnaire (CPQ) between Test product1 and Placebo at the first lactose challenge of Visit 2, compared to baseline (Visit 0) | Global score of CPQ is calculated as the sum of individual gastrointestinal symptom score of pain, bloating, flatulence, nausea and diarrhoea, each of which is defined as score of change from the time point 0 min to the time point with the maximal value during the period of 180 min after a lactose challenge | one week |
| Difference in change in global score of Carbohydrate Perception Questionnaire (CPQ) between Test product2 and Placebo at the first lactose challenge of Visit 2, compared to baseline (Visit 0) | Global score of CPQ is calculated as the sum of individual gastrointestinal symptom score of pain, bloating, flatulence, nausea and diarrhoea, each of which is defined as score of change from the time point 0 min to the time point with the maximal value during the period of 180 min after a lactose challenge | one week |
| Difference in change in global score of Carbohydrate Perception Questionnaire (CPQ) between Test product1 and Comparator at the first lactose challenge of Visit 1, compared to baseline (Visit 0) | Global score of CPQ is calculated as the sum of individual gastrointestinal symptom score of pain, bloating, flatulence, nausea and diarrhoea, each of which is defined as score of change from the time point 0 min to the time point with the maximal value during the period of 180 min after a lactose challenge | Day 1 |
| Difference in change in global score of Carbohydrate Perception Questionnaire (CPQ) between Test product2 and Comparator at the first lactose challenge of Visit 1, compared to baseline (Visit 0) | Global score of CPQ is calculated as the sum of individual gastrointestinal symptom score of pain, bloating, flatulence, nausea and diarrhoea, each of which is defined as score of change from the time point 0 min to the time point with the maximal value during the period of 180 min after a lactose challenge | Day 1 |
| Difference in change in global score of Carbohydrate Perception Questionnaire (CPQ) between Test product1 and Placebo at the first lactose challenge of Visit 1, compared to baseline (Visit 0) | Global score of CPQ is calculated as the sum of individual gastrointestinal symptom score of pain, bloating, flatulence, nausea and diarrhoea, each of which is defined as score of change from the time point 0 min to the time point with the maximal value during the period of 180 min after a lactose challenge | Day 1 |
| Difference in change in global score of Carbohydrate Perception Questionnaire (CPQ) between Test product2 and Placebo at the first lactose challenge of Visit 1, compared to baseline (Visit 0) | Global score of CPQ is calculated as the sum of individual gastrointestinal symptom score of pain, bloating, flatulence, nausea and diarrhoea, each of which is defined as score of change from the time point 0 min to the time point with the maximal value during the period of 180 min after a lactose challenge | Day 1 |
| D002239 | Carbohydrate Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |