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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01593631

Enrollment

Registered

2012-05-08

Start date

2009-09-30

Completion date

2010-04-30

Last updated

2012-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lactose Malabsorption

Keywords

lactose malabsorption, lactose intolerance, lactose digestion, lactose maldigestion, acid lactase, yoghurt bacteria

Brief 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.

Interventions

DIETARY_SUPPLEMENTAcid lactase

capsules cotaining 3300 FCC units 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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026