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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vitacare Gmbh & Co. KG
ClinicalTrials.gov Identifier:
NCT01593631
First received: May 4, 2012
Last updated: May 7, 2012
Last verified: May 2012
History of Changes
  Purpose

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.


Condition Intervention
Lactose Malabsorption
 Dietary Supplement: Acid lactase
Dietary Supplement: Lyoph. yoghurt bacteria
Dietary Supplement: Acid lactase plus yoghurt bacteria
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Vitacare Gmbh & Co. KG:

Primary Outcome Measures:
  • Increase in hydrogen concentration in the breath (H2-exhalation breath test) [ Time Frame: Every 20 minutes for 4 hours ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: September 2009
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 2 billion lyoph. yoghurt bacteria Dietary Supplement: Lyoph. yoghurt bacteria
capsules containing 2 billion lyoph. yoghurt bacteria
Active Comparator: 3300 FCC acid lactase Dietary Supplement: Acid lactase
capsules cotaining 3300 FCC units of acid lactase
Active Comparator: 9000 FCC acid lactase Dietary Supplement: Acid lactase
capsules containing 9000 FCC of acid lactase
Active Comparator: Combination of Substances of arm 1 and 2 Dietary Supplement: Acid lactase plus yoghurt bacteria
Capsules containing 3300 FCC of acid lactase and 2 billion lyoph. yoghurt bacteria
Placebo Comparator: Placebo Dietary Supplement: Placebo
Capsules containing di-calcium-phosphate

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01593631

Locations
Germany
tecura GmbH Medicine & Biotechnics - Dept. of Clinical Research
Kiel, Schleswig-Holstein, Germany, 24118
Sponsors and Collaborators
Vitacare Gmbh & Co. KG
  More Information

No publications provided

Responsible Party: Vitacare Gmbh & Co. KG
ClinicalTrials.gov Identifier: NCT01593631     History of Changes
Other Study ID Numbers: 120506000
Study First Received: May 4, 2012
Last Updated: May 7, 2012
Health Authority: Germany: Ethikkommission Schleswig-Holstein

Keywords provided by Vitacare Gmbh & Co. KG:
lactose malabsorption
lactose intolerance
lactose digestion
 lactose maldigestion
acid lactase
yoghurt bacteria

Additional relevant MeSH terms:
Lactose Intolerance
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
 Carbohydrate Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases

ClinicalTrials.gov processed this record on May 22, 2013