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CompletedNCT01593631Updated May 8, 2012

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

An interventional study of Acid lactase and Acid lactase in Lactose Malabsorption, sponsored by Vitacare Gmbh & Co. KG. Completed at 1 site in Germany. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-05-08.

Sponsored by Vitacare Gmbh & Co. KG · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

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.

02

Conditions studied

  • Lactose Malabsorption

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Keywords

  • lactose malabsorption
  • lactose intolerance
  • lactose digestion
  • lactose maldigestion
  • acid lactase
  • yoghurt bacteria
03

In context

Lactose Intolerance

53 studies on the registry are indexed under Lactose Intolerance; 6 are open to participants now.

This study's enrollment of 24 is below the median of 41 across 41 interventional studies indexed under Lactose Intolerance.

Browse Lactose Intolerance studies →

Lead sponsor

This is the only study on the registry with Vitacare Gmbh & Co. KG as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Subjects of African or Asian origin.
  • Older than 18 years
  • Written

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
24 participants (actual)

Study arms

  • Active comparator
    2 billion lyoph. yoghurt bacteria

    Dietary Supplement: Lyoph. yoghurt bacteria

  • Active comparator
    3300 FCC acid lactase

    Dietary Supplement: Acid lactase

  • Active comparator
    9000 FCC acid lactase

    Dietary Supplement: Acid lactase

  • Active comparator
    Combination of Substances of arm 1 and 2

    Dietary Supplement: Acid lactase plus yoghurt bacteria

  • Placebo comparator
    Placebo

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementAcid lactase

    capsules cotaining 3300 FCC units of acid lactase

  • Dietary supplementAcid lactase

    capsules containing 9000 FCC of acid lactase

  • Dietary supplementLyoph. yoghurt bacteria

    capsules containing 2 billion lyoph. yoghurt bacteria

  • Dietary supplementAcid lactase plus yoghurt bacteria

    Capsules containing 3300 FCC of acid lactase and 2 billion lyoph. yoghurt bacteria

  • Dietary supplementPlacebo

    Capsules containing di-calcium-phosphate

06

What researchers measure

Primary outcomes

  1. Increase in hydrogen concentration in the breath (H2-exhalation breath test)

    Time frame: Every 20 minutes for 4 hours

07

Study locations

1 site
  • tecura GmbH Medicine & Biotechnics - Dept. of Clinical Research
    Kiel, Schleswig-Holstein 24118, Germany
08

References and documents

Publications

  • de Vrese M, Laue C, Offick B, Soeth E, Repenning F, Thoss A, Schrezenmeir J. A combination of acid lactase from Aspergillus oryzae and yogurt bacteria improves lactose digestion in lactose maldigesters synergistically: A randomized, controlled, double-blind cross-over trial. Clin Nutr. 2015 Jun;34(3):394-9. doi: 10.1016/j.clnu.2014.06.012. Epub 2014 Jul 8. PubMed 25042846 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2009, a primary completion of Apr 2010 and a completion of Apr 2010. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 4, 2012
First posted
May 8, 2012
Start
Sep 2009
Primary completionActual
Apr 2010
CompletionActual
Apr 2010
Last update
May 8, 2012
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 8, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01593631
Lead sponsor
Vitacare Gmbh & Co. KG
Responsible party
Sponsor
First posted
May 8, 2012
Start date
Sep 2009
Primary completion
Apr 2010
Completion
Apr 2010
Last update
May 8, 2012
View the source record on ClinicalTrials.gov ↗

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