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CompletedNCT06107088Updated Jul 16, 2024

Effect of a Combination of Lactase and L. Salivarius DSM 34078 in Individuals With Lactose Intolerance

An interventional study of Active 1 and Active 2 in Lactose Intolerance, sponsored by Novozymes A/S. Completed at 1 site in Germany. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-07-16.

Sponsored by Novozymes A/S · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
76
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The goal of this clinical trial is to test whether a new combination of lactase and bacterial strain (L. Salivarius DSM 34078) can provide longer lasting beneficial effects on lactose digestion and gastrointestinal symptoms compared to lactase alone in people with lactose intolerance.

Read the detailed description

Participants will attend 3 visits (V0, V1, V2). Visit 0 is a screening/baseline visit (5 to 10 days before Visit 1), where participants will be checked for inclusion and exclusion criteria, and undergo a lactose challenge (drink a cup of lactose containing water) followed by a hydrogen breath test (HBT) and Carbohydrate Perception Questionnaire (CPQ) measured at intervals over 3 hours. At Visit 1, eligible participants are randomized into one of the four study arms: Lactase and bacterial strain combination in a capsule; lactase and bacterial strain combination in separate capsules, lactase only, or placebo. Each Visit 1 and Visit 2 takes about 8 hours, where participants take the investigational product (IP) before the first lactose challenge (with first HBT and first CPQ for 3 hours), followed by a 2-hour break with standardized meal provided, and undergo a second lactose challenge (with second HBT and second CPQ for another 3 hours). Visit 2 is scheduled one week after Visit 1, where participants take the IP once daily at home for a week and fill in a diary between Visit 1 and 2. Stool samples are collected at Visit 1 and 2.

02

Conditions studied

  • Lactose Intolerance

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Keywords

  • lactase
  • Ligilactobacillus salivarius
  • lactose intolerance
  • hydrogen breath test
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 76 is above the median of 41 across 41 interventional studies indexed under Lactose Intolerance.

Browse Lactose Intolerance studies →

Lead sponsor

Novozymes A/S is the lead sponsor of 13 studies on the registry; none are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

  1. Men and women from 18 to 65 years old

  2. Self-reported:

    • previously diagnosed lactose intolerance or
    • presumed lactose intolerance, defined as GI complaints upon intake of lactose-containing food/beverage (such as abdominal pain, distension, bloating, flatulence, nausea, diarrhea), when no lactase or lactase-containing product has been used by the subject
  3. Lactose maldigestion, confirmed by hydrogen breath test during lactose challenge at V0 (increase in H2 concentration of ≥ 20 parts per million (ppm) compared to value at t=0, during first 3 hours upon challenge)
  4. Generally in good health as per investigator's judgement

  5. Subject's ability and agreement to comply with study procedures, in particular:

    1. to adhere to conditions prior to test days
    2. keep the habitual dietary habits and physical activity (except with regard to conditions prior to test days); however, the consumption of lactose-containing products between V1 and V2 should be encouraged
    3. to complete study visits as required
    4. to avoid the use of other products which may influence the GI complaints during the study
    5. to avoid the use of lactase during the study
    6. to complete the subject diary and study questionnaires (including the questions that require the use of the Visual Analogue Scale (VAS))

  6. Women of :

    1. commitment to use appropriate methods
    2. negative pregnancy testing (beta human chorionic gonadotropin test in urine)
  7. Readiness not to participate in another clinical study during this study

Participation is based upon written by the participant following written and oral information by the investigator regarding nature, purpose, consequences and possible risks of the clinical study.

Exclusion criteria

Exclusion Criteria:

  1. Self-reported known allergy or to any components of the products and/or chlorhexidine and/or standardised on-site meal
  2. Self-reported congenital lactase deficiency (CLD)
  3. Self-reported galactosemia
  4. Self-reported history and/or presence of relevant GI disease or digestion/absorption disorder (e.g. inflammatory bowel disease, coeliac disease, gastroenteritis, severe constipation etc.) except for irritable bowel syndrome ((IBS); this condition is acceptable)
  5. Self-reported inexplicable weight loss (>5%) within the last 3 months prior to study
  6. Pulmonary disease that may interfere with the HBT
  7. Hospital Anxiety and Depression Scale (HADS) anxiety or depression score of ≥11 at V0
  8. Patient Health Questionnaire for Somatization (PHQ-15) score ≥15 at V0

  9. Self-reported history and/or presence of other condition/disorder, which per investigator's judgement could interfere with the results of the study or the safety of the subject, e.g.:

    1. uncontrolled thyroid gland disorder
    2. uncontrolled hypertension
    3. diabetes mellitus
    4. immunodeficiency
    5. scleroderma
    6. any other relevant serious organ or systemic diseases (e.g. cardiovascular, liver, renal, malignant, psychiatric disease etc.)
  10. Significant GI surgery (except cholecystectomy, appendectomy) within the last 6 months prior to or planned during the study
  11. Smoking
  12. Colonoscopy or colon cleaning procedure within the last 4 weeks prior to and during the study

  13. Regular medication and/or supplementation within the last 4 weeks prior to and during the study:

    1. antibiotics
    2. probiotics
    3. for management of LI complaints or any other that could influence gastrointestinal functions (e.g. laxatives (including fermentable dietary fibers), opioids, systemic , anticholinergics, anti-diarrheals, spasmolytics, prokinetics etc.) as per investigator judgement; intake of lactase prior to study is allowed
  14. Clinically relevant deviation of safety laboratory parameter(s) at V0
  15. Women of : pregnancy or nursing
  16. History of or current abuse of drugs, alcohol or medication
  17. Participation in another study during the last 30 days prior to and during the study
  18. Any other reason for exclusion as per investigator's judgment, e.g. insufficient compliance with study procedures
Terms in these criteria, in plain language(7)

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.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

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.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
76 participants (actual)

Study arms

  • Experimental
    Test product1

    1 capsule 'lactase-bacterial strain combination' and 1 capsule placebo, once a day, one week

    Dietary Supplement: Active 2 · Dietary Supplement: Placebo

  • Experimental
    Test product2

    1 capsule lactase and 1 capsule bacterial strain, once a day, one week

    Dietary Supplement: Active 1 · Dietary Supplement: Active 3

  • Active comparator
    Comparator

    1 capsule lactase and 1 capsule placebo, once a day, one week

    Dietary Supplement: Active 1 · Dietary Supplement: Placebo

  • Placebo comparator
    Placebo

    2 capsules placebo, once a day, one week

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementActive 1

    lactase enzyme

  • Dietary supplementActive 2

    lactase-bacterial strain combination

  • Dietary supplementActive 3

    bacterial strain alone

  • Dietary supplementPlacebo

    placebo

06

What researchers measure

Primary outcomes

  1. Difference in change in concentration of breath hydrogen between Test product1 and Comparator at the second lactose challenge of Visit 2, compared to baseline (Visit 0)

    Change in the hydrogen concentration in the breath after lactose challenge is measured as incremental area under the curve (iAUC) for a period of 180 minutes

    Time frame: one week

  2. Difference in change in concentration of breath hydrogen between Test product2 and Comparator at the second lactose challenge of Visit 2, compared to baseline (Visit 0)

    Change in the hydrogen concentration in the breath after lactose challenge is measured as incremental area under the curve (iAUC) for a period of 180 minutes

    Time frame: one week

Secondary outcomes

  1. Difference in change in concentration of breath hydrogen between Test product1 and Placebo at the second lactose challenge of Visit 2, compared to baseline (Visit 0)

    Change in the hydrogen concentration in the breath after lactose challenge is measured as incremental area under the curve (iAUC) for a period of 180 minutes

    Time frame: one week

  2. Difference in change in concentration of breath hydrogen between Test product2 and Placebo at the second lactose challenge of Visit 2, compared to baseline (Visit 0)

    Change in the hydrogen concentration in the breath after lactose challenge is measured as incremental area under the curve (iAUC) for a period of 180 minutes

    Time frame: one week

  3. Difference in change in concentration of breath hydrogen between Test product1 and Comparator at the second lactose challenge of Visit 1, compared to baseline (Visit 0)

    Change in the hydrogen concentration in the breath after lactose challenge is measured as incremental area under the curve (iAUC) for a period of 180 minutes

    Time frame: Day 1

  4. Difference in change in concentration of breath hydrogen between Test product2 and Comparator at the second lactose challenge of Visit 1, compared to baseline (Visit 0)

    Change in the hydrogen concentration in the breath after lactose challenge is measured as incremental area under the curve (iAUC) for a period of 180 minutes

    Time frame: Day 1

  5. Difference in change in concentration of breath hydrogen between Test product1 and Placebo at the second lactose challenge of Visit 1, compared to baseline (Visit 0)

    Change in the hydrogen concentration in the breath after lactose challenge is measured as incremental area under the curve (iAUC) for a period of 180 minutes

    Time frame: Day 1

  6. Difference in change in concentration of breath hydrogen between Test product2 and Placebo at the second lactose challenge of Visit 1, compared to baseline (Visit 0)

    Change in the hydrogen concentration in the breath after lactose challenge is measured as incremental area under the curve (iAUC) for a period of 180 minutes

    Time frame: Day 1

  7. Difference in change in concentration of breath hydrogen between Test product1 and Comparator at the first lactose challenge of Visit 2, compared to baseline (Visit 0)

    Change in the hydrogen concentration in the breath after lactose challenge is measured as incremental area under the curve (iAUC) for a period of 180 minutes

    Time frame: one week

  8. Difference in change in concentration of breath hydrogen between Test product2 and Comparator at the first lactose challenge of Visit 2, compared to baseline (Visit 0)

    Change in the hydrogen concentration in the breath after lactose challenge is measured as incremental area under the curve (iAUC) for a period of 180 minutes

    Time frame: one week

  9. Difference in change in concentration of breath hydrogen between Test product1 and Placebo at the first lactose challenge of Visit 2, compared to baseline (Visit 0)

    Change in the hydrogen concentration in the breath after lactose challenge is measured as incremental area under the curve (iAUC) for a period of 180 minutes

    Time frame: one week

  10. Difference in change in concentration of breath hydrogen between Test product2 and Placebo at the first lactose challenge of Visit 2, compared to baseline (Visit 0)

    Change in the hydrogen concentration in the breath after lactose challenge is measured as incremental area under the curve (iAUC) for a period of 180 minutes

    Time frame: one week

  11. Difference in change in concentration of breath hydrogen between Test product1 and Comparator at the first lactose challenge of Visit 1, compared to baseline (Visit 0)

    Change in the hydrogen concentration in the breath after lactose challenge is measured as incremental area under the curve (iAUC) for a period of 180 minutes

    Time frame: Day 1

  12. Difference in change in concentration of breath hydrogen between Test product2 and Comparator at the first lactose challenge of Visit 1, compared to baseline (Visit 0)

    Change in the hydrogen concentration in the breath after lactose challenge is measured as incremental area under the curve (iAUC) for a period of 180 minutes

    Time frame: Day 1

  13. Difference in change in concentration of breath hydrogen between Test product1 and Placebo at the first lactose challenge of Visit 1, compared to baseline (Visit 0)

    Change in the hydrogen concentration in the breath after lactose challenge is measured as incremental area under the curve (iAUC) for a period of 180 minutes

    Time frame: Day 1

  14. Difference in change in concentration of breath hydrogen between Test product2 and Placebo at the first lactose challenge of Visit 1, compared to baseline (Visit 0)

    Change in the hydrogen concentration in the breath after lactose challenge is measured as incremental area under the curve (iAUC) for a period of 180 minutes

    Time frame: Day 1

  15. Difference in change in global score of Carbohydrate Perception Questionnaire (CPQ) between Test product1 and Comparator at the second lactose challenge of Visit 2, compared to baseline (Visit 0)

    Global score of CPQ is calculated as the sum of individual gastrointestinal symptom score of pain, bloating, flatulence, nausea and diarrhoea, each of which is defined as score of change from the time point 0 min to the time point with the maximal value during the period of 180 min after a lactose challenge

    Time frame: one week

  16. Difference in change in global score of Carbohydrate Perception Questionnaire (CPQ) between Test product2 and Comparator at the second lactose challenge of Visit 2, compared to baseline (Visit 0)

    Global score of CPQ is calculated as the sum of individual gastrointestinal symptom score of pain, bloating, flatulence, nausea and diarrhoea, each of which is defined as score of change from the time point 0 min to the time point with the maximal value during the period of 180 min after a lactose challenge

    Time frame: one week

  17. Difference in change in global score of Carbohydrate Perception Questionnaire (CPQ) between Test product1 and Placebo at the second lactose challenge of Visit 2, compared to baseline (Visit 0)

    Global score of CPQ is calculated as the sum of individual gastrointestinal symptom score of pain, bloating, flatulence, nausea and diarrhoea, each of which is defined as score of change from the time point 0 min to the time point with the maximal value during the period of 180 min after a lactose challenge

    Time frame: one week

  18. Difference in change in global score of Carbohydrate Perception Questionnaire (CPQ) between Test product2 and Placebo at the second lactose challenge of Visit 2, compared to baseline (Visit 0)

    Global score of CPQ is calculated as the sum of individual gastrointestinal symptom score of pain, bloating, flatulence, nausea and diarrhoea, each of which is defined as score of change from the time point 0 min to the time point with the maximal value during the period of 180 min after a lactose challenge

    Time frame: one week

  19. Difference in change in global score of Carbohydrate Perception Questionnaire (CPQ) between Test product1 and Comparator at the second lactose challenge of Visit 1, compared to baseline (Visit 0)

    Global score of CPQ is calculated as the sum of individual gastrointestinal symptom score of pain, bloating, flatulence, nausea and diarrhoea, each of which is defined as score of change from the time point 0 min to the time point with the maximal value during the period of 180 min after a lactose challenge

    Time frame: Day 1

  20. Difference in change in global score of Carbohydrate Perception Questionnaire (CPQ) between Test product2 and Comparator at the second lactose challenge of Visit 1, compared to baseline (Visit 0)

    Global score of CPQ is calculated as the sum of individual gastrointestinal symptom score of pain, bloating, flatulence, nausea and diarrhoea, each of which is defined as score of change from the time point 0 min to the time point with the maximal value during the period of 180 min after a lactose challenge

    Time frame: Day 1

  21. Difference in change in global score of Carbohydrate Perception Questionnaire (CPQ) between Test product1 and Placebo at the second lactose challenge of Visit 1, compared to baseline (Visit 0)

    Global score of CPQ is calculated as the sum of individual gastrointestinal symptom score of pain, bloating, flatulence, nausea and diarrhoea, each of which is defined as score of change from the time point 0 min to the time point with the maximal value during the period of 180 min after a lactose challenge

    Time frame: Day 1

  22. Difference in change in global score of Carbohydrate Perception Questionnaire (CPQ) between Test product2 and Placebo at the second lactose challenge of Visit 1, compared to baseline (Visit 0)

    Global score of CPQ is calculated as the sum of individual gastrointestinal symptom score of pain, bloating, flatulence, nausea and diarrhoea, each of which is defined as score of change from the time point 0 min to the time point with the maximal value during the period of 180 min after a lactose challenge

    Time frame: Day 1

  23. Difference in change in global score of Carbohydrate Perception Questionnaire (CPQ) between Test product1 and Comparator at the first lactose challenge of Visit 2, compared to baseline (Visit 0)

    Global score of CPQ is calculated as the sum of individual gastrointestinal symptom score of pain, bloating, flatulence, nausea and diarrhoea, each of which is defined as score of change from the time point 0 min to the time point with the maximal value during the period of 180 min after a lactose challenge

    Time frame: one week

  24. Difference in change in global score of Carbohydrate Perception Questionnaire (CPQ) between Test product2 and Comparator at the first lactose challenge of Visit 2, compared to baseline (Visit 0)

    Global score of CPQ is calculated as the sum of individual gastrointestinal symptom score of pain, bloating, flatulence, nausea and diarrhoea, each of which is defined as score of change from the time point 0 min to the time point with the maximal value during the period of 180 min after a lactose challenge

    Time frame: one week

  25. Difference in change in global score of Carbohydrate Perception Questionnaire (CPQ) between Test product1 and Placebo at the first lactose challenge of Visit 2, compared to baseline (Visit 0)

    Global score of CPQ is calculated as the sum of individual gastrointestinal symptom score of pain, bloating, flatulence, nausea and diarrhoea, each of which is defined as score of change from the time point 0 min to the time point with the maximal value during the period of 180 min after a lactose challenge

    Time frame: one week

  26. Difference in change in global score of Carbohydrate Perception Questionnaire (CPQ) between Test product2 and Placebo at the first lactose challenge of Visit 2, compared to baseline (Visit 0)

    Global score of CPQ is calculated as the sum of individual gastrointestinal symptom score of pain, bloating, flatulence, nausea and diarrhoea, each of which is defined as score of change from the time point 0 min to the time point with the maximal value during the period of 180 min after a lactose challenge

    Time frame: one week

  27. Difference in change in global score of Carbohydrate Perception Questionnaire (CPQ) between Test product1 and Comparator at the first lactose challenge of Visit 1, compared to baseline (Visit 0)

    Global score of CPQ is calculated as the sum of individual gastrointestinal symptom score of pain, bloating, flatulence, nausea and diarrhoea, each of which is defined as score of change from the time point 0 min to the time point with the maximal value during the period of 180 min after a lactose challenge

    Time frame: Day 1

  28. Difference in change in global score of Carbohydrate Perception Questionnaire (CPQ) between Test product2 and Comparator at the first lactose challenge of Visit 1, compared to baseline (Visit 0)

    Global score of CPQ is calculated as the sum of individual gastrointestinal symptom score of pain, bloating, flatulence, nausea and diarrhoea, each of which is defined as score of change from the time point 0 min to the time point with the maximal value during the period of 180 min after a lactose challenge

    Time frame: Day 1

  29. Difference in change in global score of Carbohydrate Perception Questionnaire (CPQ) between Test product1 and Placebo at the first lactose challenge of Visit 1, compared to baseline (Visit 0)

    Global score of CPQ is calculated as the sum of individual gastrointestinal symptom score of pain, bloating, flatulence, nausea and diarrhoea, each of which is defined as score of change from the time point 0 min to the time point with the maximal value during the period of 180 min after a lactose challenge

    Time frame: Day 1

  30. Difference in change in global score of Carbohydrate Perception Questionnaire (CPQ) between Test product2 and Placebo at the first lactose challenge of Visit 1, compared to baseline (Visit 0)

    Global score of CPQ is calculated as the sum of individual gastrointestinal symptom score of pain, bloating, flatulence, nausea and diarrhoea, each of which is defined as score of change from the time point 0 min to the time point with the maximal value during the period of 180 min after a lactose challenge

    Time frame: Day 1

07

Study locations

1 site
  • Analyze & Realize Study Center
    Berlin, Germany
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2023 to primary completion in Jul 2024, 7 months.

Of 22 interventional studies with no phase under Lactose Intolerance, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 14. This study's 7 months is below that.

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

Registered
Oct 24, 2023
First posted
Oct 30, 2023
StartActual
Nov 20, 2023
Primary completionActual
Jul 10, 2024
CompletionActual
Jul 10, 2024
Last update
Jul 16, 2024
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 Jul 16, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06107088
Lead sponsor
Novozymes A/S
Collaborators
Analyze & Realize
Responsible party
Sponsor
First posted
Oct 30, 2023
Start date
Nov 20, 2023
Primary completion
Jul 10, 2024
Completion
Jul 10, 2024
Last update
Jul 16, 2024

Study contacts

Liana Vismane, MD
principal investigator · analyze & realize GmbH

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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