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Completed

NCT Number: NCT01593631

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

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.

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Key information

Conditions

Lactose Malabsorption Carbohydrate Metabolism, Inborn Errors Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Gastrointestinal Diseases Genetic Diseases, Inborn Intestinal Diseases Lactose Intolerance Malabsorption Syndromes Metabolic Diseases Metabolism, Inborn Errors Nutritional and Metabolic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

tecura GmbH Medicine & Biotechnics - Dept. of Clinical Research

Kiel, Schleswig-Holstein, 24118, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acid lactase

Dietary Supplement

capsules cotaining 3300 FCC units of acid lactase

Lyoph. yoghurt bacteria

Dietary Supplement

capsules containing 2 billion lyoph. yoghurt bacteria

Acid lactase plus yoghurt bacteria

Dietary Supplement

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

Placebo

Dietary Supplement

Capsules containing di-calcium-phosphate

Primary outcomes

  1. Increase in hydrogen concentration in the breath (H2-exhalation breath test)

    Time frame: Every 20 minutes for 4 hours

Sponsors and collaborators

Lead sponsor

Vitacare Gmbh & Co. KG

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
May 8, 2012
Registry last updated
May 8, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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