Acid Lactase in Combination With Yoghurt Bacteria for Improvement of Lactose Digestion in Lactose Malabsorbers
Primary Purpose
Lactose Malabsorption
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Acid lactase
Acid lactase
Lyoph. yoghurt bacteria
Acid lactase plus yoghurt bacteria
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Lactose Malabsorption focused on measuring lactose malabsorption, lactose intolerance, lactose digestion, lactose maldigestion, acid lactase, yoghurt bacteria
Eligibility 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
Sites / Locations
- tecura GmbH Medicine & Biotechnics - Dept. of Clinical Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
2 billion lyoph. yoghurt bacteria
3300 FCC acid lactase
9000 FCC acid lactase
Combination of Substances of arm 1 and 2
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Increase in hydrogen concentration in the breath (H2-exhalation breath test)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01593631
Brief Title
Acid Lactase in Combination With Yoghurt Bacteria for Improvement of Lactose Digestion in Lactose Malabsorbers
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vitacare Gmbh & Co. KG
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lactose Malabsorption
Keywords
lactose malabsorption, lactose intolerance, lactose digestion, lactose maldigestion, acid lactase, yoghurt bacteria
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2 billion lyoph. yoghurt bacteria
Arm Type
Active Comparator
Arm Title
3300 FCC acid lactase
Arm Type
Active Comparator
Arm Title
9000 FCC acid lactase
Arm Type
Active Comparator
Arm Title
Combination of Substances of arm 1 and 2
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Acid lactase
Intervention Description
capsules cotaining 3300 FCC units of acid lactase
Intervention Type
Dietary Supplement
Intervention Name(s)
Acid lactase
Intervention Description
capsules containing 9000 FCC of acid lactase
Intervention Type
Dietary Supplement
Intervention Name(s)
Lyoph. yoghurt bacteria
Intervention Description
capsules containing 2 billion lyoph. yoghurt bacteria
Intervention Type
Dietary Supplement
Intervention Name(s)
Acid lactase plus yoghurt bacteria
Intervention Description
Capsules containing 3300 FCC of acid lactase and 2 billion lyoph. yoghurt bacteria
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Capsules containing di-calcium-phosphate
Primary Outcome Measure Information:
Title
Increase in hydrogen concentration in the breath (H2-exhalation breath test)
Time Frame
Every 20 minutes for 4 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
tecura GmbH Medicine & Biotechnics - Dept. of Clinical Research
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24118
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
25042846
Citation
de Vrese M, Laue C, Offick B, Soeth E, Repenning F, Thoss A, Schrezenmeir J. A combination of acid lactase from Aspergillus oryzae and yogurt bacteria improves lactose digestion in lactose maldigesters synergistically: A randomized, controlled, double-blind cross-over trial. Clin Nutr. 2015 Jun;34(3):394-9. doi: 10.1016/j.clnu.2014.06.012. Epub 2014 Jul 8.
Results Reference
derived
Learn more about this trial
Acid Lactase in Combination With Yoghurt Bacteria for Improvement of Lactose Digestion in Lactose Malabsorbers
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