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

May 4, 2012
May 7, 2012
September 2009
April 2010   (final data collection date for primary outcome measure)
Increase in hydrogen concentration in the breath (H2-exhalation breath test) [ Time Frame: Every 20 minutes for 4 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01593631 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Lactose Malabsorption
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
April 2010
April 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01593631
120506000
Not Provided
Vitacare Gmbh & Co. KG
Vitacare Gmbh & Co. KG
Not Provided
Not Provided
Vitacare Gmbh & Co. KG
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP