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

Tracking Information
First Received Date ^ICMJE	May 4, 2012
Last Updated Date	May 7, 2012
Start Date ^ICMJE	September 2009
Primary Completion Date	April 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 7, 2012)	Increase in hydrogen concentration in the breath (H2-exhalation breath test) [ Time Frame: Every 20 minutes for 4 hours ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01593631 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Acid Lactase in Combination With Yoghurt Bacteria for Improvement of Lactose Digestion in Lactose Malabsorbers
Official Title ^ICMJE	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
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Lactose Malabsorption
Intervention ^ICMJE	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
Study Arm (s)	Active Comparator: 2 billion lyoph. yoghurt bacteria Intervention: Dietary Supplement: Lyoph. yoghurt bacteria Active Comparator: 3300 FCC acid lactase Intervention: Dietary Supplement: Acid lactase Active Comparator: 9000 FCC acid lactase Intervention: Dietary Supplement: Acid lactase Active Comparator: Combination of Substances of arm 1 and 2 Intervention: Dietary Supplement: Acid lactase plus yoghurt bacteria Placebo Comparator: Placebo Intervention: Dietary Supplement: Placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	24
Completion Date	April 2010
Primary Completion Date	April 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 60 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Germany

Administrative Information
NCT Number ^ICMJE	NCT01593631
Other Study ID Numbers ^ICMJE	120506000
Has Data Monitoring Committee	Not Provided
Responsible Party	Vitacare Gmbh & Co. KG
Study Sponsor ^ICMJE	Vitacare Gmbh & Co. KG
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Vitacare Gmbh & Co. KG
Verification Date	May 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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