Lactose MalabsorptionNCT01593631
Acid Lactase in Combination With Yoghurt Bacteria for Improvement of Lactose Digestion in Lactose Malabsorbers
A study testing Acid lactase, Lyoph. yoghurt bacteria and Acid lactase plus yoghurt bacteria in people with Lactose Malabsorption, run by Vitacare Gmbh & Co. KG at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Lactose Malabsorption
- What is being tested?
- Acid lactase, Lyoph. yoghurt bacteria and Acid lactase plus yoghurt bacteria
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2009to Apr 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects of African or Asian origin.
- Older than 18 years
- Written informed consent
Who cannot join
- 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;
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- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
tecura GmbH Medicine & Biotechnics - Dept. of Clinical Research
Kiel, Schleswig-Holstein, 24118
About this study
Official title: 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.
- Conditions
- Lactose Malabsorption
- Being tested
- Acid lactase, Lyoph. yoghurt bacteria, Acid lactase plus yoghurt bacteria, Placebo
- Keywords
- lactose malabsorption, lactose intolerance, lactose digestion, lactose maldigestion, acid lactase, yoghurt bacteria
- Medical subject headings
- Lactose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acid lactaseDietary supplement
capsules cotaining 3300 FCC units of acid lactase
Acid lactaseDietary supplement
capsules containing 9000 FCC of acid lactase
Lyoph. yoghurt bacteriaDietary supplement
capsules containing 2 billion lyoph. yoghurt bacteria
Acid lactase plus yoghurt bacteriaDietary supplement
Capsules containing 3300 FCC of acid lactase and 2 billion lyoph. yoghurt bacteria
PlaceboDietary supplement
Capsules containing di-calcium-phosphate
| Study group | Role | What they receive |
|---|---|---|
| 2 billion lyoph. yoghurt bacteria | Active comparator | Not described Receives: Dietary Supplement: Lyoph. yoghurt bacteria |
| 3300 FCC acid lactase | Active comparator | Not described Receives: Dietary Supplement: Acid lactase |
| 9000 FCC acid lactase | Active comparator | Not described Receives: Dietary Supplement: Acid lactase |
| Combination of Substances of arm 1 and 2 | Active comparator | Not described Receives: Dietary Supplement: Acid lactase plus yoghurt bacteria |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in hydrogen concentration in the breath (H2-exhalation breath test)
Measured: Every 20 minutes for 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2012 (estimated)
- Study startSep 2009
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lactose MalabsorptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vitacare Gmbh & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01593631
- Sponsor's protocol ID
- 120506000
- Status last verified
- May 2012
- First submitted
- 4 May 2012
- Last updated
- 8 May 2012
- Results posted
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01593631
- Acronym / sponsor ID
- 120506000
- Conditions
- Lactose Malabsorption
- Keywords
- lactose malabsorption, lactose intolerance, lactose digestion, lactose maldigestion, acid lactase, yoghurt bacteria
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Vitacare Gmbh & Co. KGIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 8 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Subjects of African or Asian origin.
- Older than 18 years
- Written informed consent
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acid lactasecapsules cotaining 3300 FCC units of acid lactase | Dietary supplement | 3300 FCC acid lactase |
| Acid lactasecapsules containing 9000 FCC of acid lactase | Dietary supplement | 9000 FCC acid lactase |
| Lyoph. yoghurt bacteriacapsules containing 2 billion lyoph. yoghurt bacteria | Dietary supplement | 2 billion lyoph. yoghurt bacteria |
| Acid lactase plus yoghurt bacteriaCapsules containing 3300 FCC of acid lactase and 2 billion lyoph. yoghurt bacteria | Dietary supplement | Combination of Substances of arm 1 and 2 |
| PlaceboCapsules containing di-calcium-phosphate | Dietary supplement | Placebo |
Primary outcome
Increase in hydrogen concentration in the breath (H2-exhalation breath test)
Time frame: Every 20 minutes for 4 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2012.
- Derived from this study: PubMed 25042846de 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acid lactase, Lyoph. yoghurt bacteria and Acid lactase plus yoghurt bacteria in people with Lactose Malabsorption, run by Vitacare Gmbh & Co. KG at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase in hydrogen concentration in the breath (H2-exhalation breath test) (time frame: Every 20 minutes for 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01593631, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2012.