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

Vitacare

Status: Completed

Conditions: Lactose Malabsorption

Treatments: Dietary Supplement: Lyoph. yoghurt bacteria; Dietary Supplement: Acid lactase plus yoghurt bacteria; Dietary Supplement: Placebo; Dietary Supplement: Acid lactase

Study type: Interventional

Funder types: Industry

Identifiers

NCT01593631

120506000

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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24 participants in 5 patient groups, including a placebo group

2 billion lyoph. yoghurt bacteria

Active Comparator group

Treatment:

Dietary Supplement: Lyoph. yoghurt bacteria

3300 FCC acid lactase

Active Comparator group

Treatment:

Dietary Supplement: Acid lactase

Dietary Supplement: Acid lactase

9000 FCC acid lactase

Active Comparator group

Treatment:

Dietary Supplement: Acid lactase

Dietary Supplement: Acid lactase

Combination of Substances of arm 1 and 2

Active Comparator group

Treatment:

Dietary Supplement: Acid lactase plus yoghurt bacteria

Placebo

Placebo Comparator group

Treatment:

Dietary Supplement: Placebo