Acid Lactase in Combination With Yoghurt Bacteria for Improvement of Lactose Digestion in Lactose Malabsorbers
NCT ID: NCT01593631
Last Updated: 2012-05-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
24 participants
INTERVENTIONAL
2009-09-30
2010-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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2 billion lyoph. yoghurt bacteria
Lyoph. yoghurt bacteria
capsules containing 2 billion lyoph. yoghurt bacteria
3300 FCC acid lactase
Acid lactase
capsules cotaining 3300 FCC units of acid lactase
9000 FCC acid lactase
Acid lactase
capsules containing 9000 FCC of acid lactase
Combination of Substances of arm 1 and 2
Acid lactase plus yoghurt bacteria
Capsules containing 3300 FCC of acid lactase and 2 billion lyoph. yoghurt bacteria
Placebo
Placebo
Capsules containing di-calcium-phosphate
Interventions
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Acid lactase
capsules cotaining 3300 FCC units of acid lactase
Acid lactase
capsules containing 9000 FCC of acid lactase
Lyoph. yoghurt bacteria
capsules containing 2 billion lyoph. yoghurt bacteria
Acid lactase plus yoghurt bacteria
Capsules containing 3300 FCC of acid lactase and 2 billion lyoph. yoghurt bacteria
Placebo
Capsules containing di-calcium-phosphate
Eligibility Criteria
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Inclusion Criteria
* Older than 18 years
* Written informed consent
Exclusion Criteria
* 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
18 Years
60 Years
ALL
Yes
Sponsors
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Vitacare Gmbh & Co. KG
INDUSTRY
Responsible Party
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Locations
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tecura GmbH Medicine & Biotechnics - Dept. of Clinical Research
Kiel, Schleswig-Holstein, Germany
Countries
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References
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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.
Other Identifiers
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120506000
Identifier Type: -
Identifier Source: org_study_id
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