Trial | NCT01593631  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    24
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 Started
Sep 30
2009
Primary Completion
Apr 30
2010
Study Completion
Apr 30
2010
Last Update
May 08
2012
Estimate

Dietary Supplement Acid lactase

capsules cotaining 3300 FCC units of acid lactase

Dietary Supplement Acid lactase

capsules containing 9000 FCC of acid lactase

Dietary Supplement Lyoph. yoghurt bacteria

capsules containing 2 billion lyoph. yoghurt bacteria

Dietary Supplement Acid lactase plus yoghurt bacteria

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

Dietary Supplement Placebo

Capsules containing di-calcium-phosphate

2 billion lyoph. yoghurt bacteria Active Comparator

3300 FCC acid lactase Active Comparator

9000 FCC acid lactase Active Comparator

Combination of Substances of arm 1 and 2 Active Comparator

Placebo Placebo Comparator

Criteria 

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
No Results Posted