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

Lactose Malabsorption Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01593631
• Other study ID #: 120506000
• Status: Completed
• Phase: N/A
• First received: May 4, 2012
• Last updated: May 7, 2012
• Start date: September 2009
• Est. completion date: April 2010

Study information

• Verified date: May 2012
• Source: Vitacare Gmbh & Co. KG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethikkommission Schleswig-Holstein
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Lactose Intolerance
• Lactose Malabsorption
• Malabsorption Syndromes

Intervention

Dietary Supplement:
• Acid lactase
capsules cotaining 3300 FCC units of acid lactase
• Acid lactase
capsules containing 9000 FCC of acid lactase
• Lyoph. yoghurt bacteria
capsules containing 2 billion lyoph. yoghurt bacteria
• Acid lactase plus yoghurt bacteria
Capsules containing 3300 FCC of acid lactase and 2 billion lyoph. yoghurt bacteria
• Placebo
Capsules containing di-calcium-phosphate

Locations

Country	Name	City	State
Germany	tecura GmbH Medicine & Biotechnics - Dept. of Clinical Research	Kiel	Schleswig-Holstein

Sponsors (1)

Lead Sponsor	Collaborator
Vitacare Gmbh & Co. KG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase in hydrogen concentration in the breath (H2-exhalation breath test)		Every 20 minutes for 4 hours	No