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Fermented dairy products, especially real Yoghurt, are often tolerated better by lactose malabsorbers than unfermented dairy products. The intake of dietary supplements containing acid Lactase derived from Aspergillus oryzae with lactose containing foodstuffs is known to reduce/alleviate symptoms of lactose intolerance in lactose malabsorbers. The study aims to compare the effect of the intake of a combination of yoghurt bacteria and acid lactase to the effect of yogurt bacteria or acid lactase alone on the lactose digestion in lactose malabsorbers. It is hypothized that the combination preparation will be more effective and/or will show a more reliable effect than the two mono-preparations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 billion lyoph. yoghurt bacteria | Active Comparator |
| |
| 3300 FCC acid lactase | Active Comparator |
| |
| 9000 FCC acid lactase | Active Comparator |
| |
| Combination of Substances of arm 1 and 2 | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acid lactase | Dietary Supplement | capsules cotaining 3300 FCC units of acid lactase |
|
| Measure | Description | Time Frame |
|---|---|---|
| Increase in hydrogen concentration in the breath (H2-exhalation breath test) | Every 20 minutes for 4 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| tecura GmbH Medicine & Biotechnics - Dept. of Clinical Research | Kiel | Schleswig-Holstein | 24118 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25042846 | Derived | de Vrese M, Laue C, Offick B, Soeth E, Repenning F, Thoss A, Schrezenmeir J. A combination of acid lactase from Aspergillus oryzae and yogurt bacteria improves lactose digestion in lactose maldigesters synergistically: A randomized, controlled, double-blind cross-over trial. Clin Nutr. 2015 Jun;34(3):394-9. doi: 10.1016/j.clnu.2014.06.012. Epub 2014 Jul 8. |
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| Acid lactase | Dietary Supplement | capsules containing 9000 FCC of acid lactase |
|
| Lyoph. yoghurt bacteria | Dietary Supplement | capsules containing 2 billion lyoph. yoghurt bacteria |
|
| Acid lactase plus yoghurt bacteria | Dietary Supplement | Capsules containing 3300 FCC of acid lactase and 2 billion lyoph. yoghurt bacteria |
|
| Placebo | Dietary Supplement | Capsules containing di-calcium-phosphate |
|
| ID | Term |
|---|---|
| D007787 | Lactose Intolerance |
| ID | Term |
|---|---|
| D008286 | Malabsorption Syndromes |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| 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 |
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