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

Study Overview
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Brief Summary
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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.

Official Title
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A Combination of Yoghurt Bacteria and Acid Lactase From Aspergillus Oryzae Improves Lactose Digestion in Lactose Malabsorbers More Reliably Than Preparations Containing Acid Lactase or Yoghurt Bacteria Alone

Conditions
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Lactose Malabsorption

Intervention / Treatment
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* Dietary Supplement: Acid lactase
* Dietary Supplement: Acid lactase
* Dietary Supplement: Lyoph. yoghurt bacteria
* Dietary Supplement: Acid lactase plus yoghurt bacteria
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 2 billion lyoph. yoghurt bacteria<br> | Dietary Supplement: Lyoph. yoghurt bacteria<br>* capsules containing 2 billion lyoph. yoghurt bacteria<br>|
| Active Comparator: 3300 FCC acid lactase<br> | Dietary Supplement: Acid lactase<br>* capsules cotaining 3300 FCC units of acid lactase<br>|
| Active Comparator: 9000 FCC acid lactase<br> | Dietary Supplement: Acid lactase<br>* capsules containing 9000 FCC of acid lactase<br>|
| Active Comparator: Combination of Substances of arm 1 and 2<br> | Dietary Supplement: Acid lactase plus yoghurt bacteria<br>* Capsules containing 3300 FCC of acid lactase and 2 billion lyoph. yoghurt bacteria<br>|
| Placebo Comparator: Placebo<br> | Dietary Supplement: Placebo<br>* Capsules containing di-calcium-phosphate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase in hydrogen concentration in the breath (H2-exhalation breath test) |  | Every 20 minutes for 4 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lactose malabsorption, lactose intolerance, lactose digestion, lactose maldigestion, acid lactase, yoghurt bacteria