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

Not Applicable

Completed

• Conditions: Lactose Malabsorption
• Interventions: Dietary Supplement: Lyoph. yoghurt bacteria; Dietary Supplement: Acid lactase; Dietary Supplement: Acid lactase plus yoghurt bacteria; Dietary Supplement: Placebo

• Registration Number: NCT01593631
• Lead Sponsor: Vitacare Gmbh & Co. KG

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Status Verified: 2012-05
• Study First Submitted: 2012-05-04
• Study First Submitted QC: 2012-05-07
• Last Update Submitted: 2012-05-07
• Study First Posted: 2012-05-08
• Last Update Posted: 2012-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2 billion lyoph. yoghurt bacteria	Lyoph. yoghurt bacteria	-
3300 FCC acid lactase	Acid lactase	-
9000 FCC acid lactase	Acid lactase	-
Combination of Substances of arm 1 and 2	Acid lactase plus yoghurt bacteria	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Increase in hydrogen concentration in the breath (H2-exhalation breath test)	Every 20 minutes for 4 hours

Trial Locations

Locations (1)

tecura GmbH Medicine & Biotechnics - Dept. of Clinical Research; 🇩🇪 Kiel, Schleswig-Holstein, Germany