MedTrace Logo

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

NCT01593631 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2012-05-08

No results posted yet for this study

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.

Conditions

  • Lactose Malabsorption

Interventions

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

Sponsors & Collaborators

  • Vitacare Gmbh & Co. KG

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2010-04-30
Completion
2010-04-30

Countries

  • Germany

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01593631 on ClinicalTrials.gov