NCT01593631

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

May 4, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 8, 2012

Completed
Last Updated

May 8, 2012

Status Verified

May 1, 2012

Enrollment Period

7 months

First QC Date

May 4, 2012

Last Update Submit

May 7, 2012

Conditions

Lactose Malabsorption

Keywords

lactose malabsorptionlactose intolerancelactose digestionlactose maldigestionacid lactaseyoghurt bacteria

Outcome Measures

Primary Outcomes (1)

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

    Every 20 minutes for 4 hours

Study Arms (5)

2 billion lyoph. yoghurt bacteria

ACTIVE COMPARATOR
Dietary Supplement: Lyoph. yoghurt bacteria

3300 FCC acid lactase

ACTIVE COMPARATOR
Dietary Supplement: Acid lactase

9000 FCC acid lactase

ACTIVE COMPARATOR
Dietary Supplement: Acid lactase

Combination of Substances of arm 1 and 2

ACTIVE COMPARATOR
Dietary Supplement: Acid lactase plus yoghurt bacteria

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Interventions

Acid lactaseDIETARY_SUPPLEMENT

capsules cotaining 3300 FCC units of acid lactase

3300 FCC acid lactase
Lyoph. yoghurt bacteriaDIETARY_SUPPLEMENT

capsules containing 2 billion lyoph. yoghurt bacteria

2 billion lyoph. yoghurt bacteria
Acid lactase plus yoghurt bacteriaDIETARY_SUPPLEMENT

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

Combination of Substances of arm 1 and 2
PlaceboDIETARY_SUPPLEMENT

Capsules containing di-calcium-phosphate

Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

tecura GmbH Medicine & Biotechnics - Dept. of Clinical Research

Kiel, Schleswig-Holstein, 24118, Germany

Location

Related Publications (1)

  • 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.

    PMID: 25042846DERIVED

MeSH Terms

Conditions

Lactose Intolerance

Condition Hierarchy (Ancestors)

Malabsorption SyndromesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesCarbohydrate Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2012

First Posted

May 8, 2012

Study Start

September 1, 2009

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

May 8, 2012

Record last verified: 2012-05

Locations

DE(1)