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

May 7, 2012 updated by: Vitacare Gmbh & Co. KG

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany, 24118
        • tecura GmbH Medicine & Biotechnics - Dept. of Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Dietary supplement: Placebo
Capsules containing di-calcium-phosphate
ACTIVE_COMPARATOR: 2 billion lyoph. yoghurt bacteria
Dietary supplement: Lyoph. yoghurt bacteria
capsules containing 2 billion lyoph. yoghurt bacteria
ACTIVE_COMPARATOR: 3300 FCC acid lactase
Dietary supplement: Acid lactase
capsules cotaining 3300 FCC units of acid lactase
Dietary supplement: Acid lactase
capsules containing 9000 FCC of acid lactase
ACTIVE_COMPARATOR: 9000 FCC acid lactase
Dietary supplement: Acid lactase
capsules cotaining 3300 FCC units of acid lactase
Dietary supplement: Acid lactase
capsules containing 9000 FCC of acid lactase
ACTIVE_COMPARATOR: Combination of Substances of arm 1 and 2
Dietary supplement: Acid lactase plus yoghurt bacteria
Capsules containing 3300 FCC of acid lactase and 2 billion lyoph. yoghurt bacteria

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Increase in hydrogen concentration in the breath (H2-exhalation breath test)
Time Frame: Every 20 minutes for 4 hours
Every 20 minutes for 4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vitacare Gmbh & Co. KG

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (ACTUAL)

April 1, 2010

Study Completion (ACTUAL)

April 1, 2010

Study Registration Dates

First Submitted

May 4, 2012

First Submitted That Met QC Criteria

May 7, 2012

First Posted (ESTIMATE)

May 8, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

May 8, 2012

Last Update Submitted That Met QC Criteria

May 7, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 120506000

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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