Acid Lactase in Combination With Yoghurt Bacteria for Improvement of Lactose Digestion in Lactose Malabsorbers

Vitacare Gmbh & Co. KG24 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Lactose Malabsorption

Interventions

capsules cotaining 3300 FCC units of acid lactase

Acid lactaseDIETARY_SUPPLEMENT

capsules containing 9000 FCC of acid lactase

Lyoph. yoghurt bacteriaDIETARY_SUPPLEMENT

capsules containing 2 billion lyoph. yoghurt bacteria

Acid lactase plus yoghurt bacteriaDIETARY_SUPPLEMENT

Capsules containing 3300 FCC of acid lactase and 2 billion lyoph. yoghurt bacteria

PlaceboDIETARY_SUPPLEMENT

Capsules containing di-calcium-phosphate

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects of African or Asian origin. * Older than 18 years * Written informed consent Exclusion Criteria: * Participation in a clinical study with a drug or a medical product withing the last 30 days; * Inability to comply with the study protocol; * Allergy to milk protein; * Intolerance against lactase preparations; * Known metabolic or gastrointestinal diseases which affect the absorption, metabolism or excretion of food components except lactose maldigestion; * Intake of drugs influencing resorption of food components or gastrointestinal motility; * Surgery within the last three months which still affect the current status of health; * Psychiatric diseases * Epilepsia * Risk for suicide * Eating disorders, e.g. anorexia, bulimia * Alcohol or drug abuse * Legal incapacity

Locations (1)

tecura GmbH Medicine & Biotechnics - Dept. of Clinical Research

Kiel, Schleswig-Holstein, Germany

Outcomes

Primary Outcomes

Increase in hydrogen concentration in the breath (H2-exhalation breath test)

Time frame: Every 20 minutes for 4 hours

Data from ClinicalTrials.gov

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