Lactose IntoleranceNCT06107088
Effect of a Combination of Lactase and L. Salivarius DSM 34078 in Individuals With Lactose Intolerance
A study testing Active 1, Active 2 and Active 3 in people with Lactose Intolerance, run by Novozymes A/S at 1 site in Germany.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lactose Intolerance
- What is being tested?
- Active 1, Active 2 and Active 3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteGermany
- Study dates
- 20 Nov 2023to 10 Jul 2024
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women from 18 to 65 years old
- 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
- 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)
- Generally in good health as per investigator's judgement
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- Subject's ability and agreement to comply with study procedures, in particular:
- to adhere to conditions prior to test days
- 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
- to complete study visits as required
- to avoid the use of other products which may influence the GI complaints during the study
- to avoid the use of lactase during the study
- to complete the subject diary and study questionnaires (including the questions that require the use of the Visual Analogue Scale (VAS))
- Women of childbearing potential:
- commitment to use appropriate contraception methods
- negative pregnancy testing (beta human chorionic gonadotropin test in urine)
- Readiness not to participate in another clinical study during this study
- Participation is based upon written informed consent by the participant following written and oral information by the investigator regarding nature, purpose, consequences and possible risks of the clinical study.
Who cannot join
- Self-reported known allergy or hypersensitivity to any components of the investigational products and/or chlorhexidine and/or standardised on-site meal
- Self-reported congenital lactase deficiency (CLD)
- Self-reported galactosemia
- 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)
- Self-reported inexplicable weight loss (>5%) within the last 3 months prior to study
- Pulmonary disease that may interfere with the HBT
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- Hospital Anxiety and Depression Scale (HADS) anxiety or depression score of ≥11 at V0
- Patient Health Questionnaire for Somatization (PHQ-15) score ≥15 at V0
- Self-reported history and/or presence of other clinically significant condition/disorder, which per investigator's judgement could interfere with the results of the study or the safety of the subject, e.g.:
- uncontrolled thyroid gland disorder
- uncontrolled hypertension
- diabetes mellitus
- immunodeficiency
- scleroderma
- any other relevant serious organ or systemic diseases (e.g. cardiovascular, liver, renal, malignant, psychiatric disease etc.)
- Significant GI surgery (except cholecystectomy, appendectomy) within the last 6 months prior to or planned during the study
- Smoking
- Colonoscopy or colon cleaning procedure within the last 4 weeks prior to and during the study
- Regular medication and/or supplementation within the last 4 weeks prior to and during the study:
- antibiotics
- probiotics
- for management of LI complaints or any other that could influence gastrointestinal functions (e.g. laxatives (including fermentable dietary fibers), opioids, systemic corticosteroids, anticholinergics, anti-diarrheals, spasmolytics, prokinetics etc.) as per investigator judgement; intake of lactase prior to study is allowed
- Clinically relevant deviation of safety laboratory parameter(s) at V0
- Women of child-bearing potential: pregnancy or nursing
- History of or current abuse of drugs, alcohol or medication
- Participation in another study during the last 30 days prior to and during the study
- Any other reason for exclusion as per investigator's judgment, e.g. insufficient compliance with study procedures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Proof-of-concept Study to Evaluate the Effect and the Tolerability of a Novel Combination of Lactase Enzyme and Ligilactobacillus Salivarius DSM 34078 in Individuals With Lactose Intolerance
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.
- Conditions
- Lactose Intolerance
- Being tested
- Active 1, Active 2, Active 3, Placebo
- Keywords
- lactase, Ligilactobacillus salivarius, lactose intolerance, hydrogen breath test
- Medical subject headings
- Lactose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active 1Dietary supplement
lactase enzyme
Active 2Dietary supplement
lactase-bacterial strain combination
Active 3Dietary supplement
bacterial strain alone
PlaceboDietary supplement
placebo
| Study group | Role | What they receive |
|---|---|---|
| Test product1 | Experimental | 1 capsule 'lactase-bacterial strain combination' and 1 capsule placebo, once a day, one week Receives: Dietary Supplement: Active 2; Dietary Supplement: Placebo |
| Test product2 | Experimental | 1 capsule lactase and 1 capsule bacterial strain, once a day, one week Receives: Dietary Supplement: Active 1; Dietary Supplement: Active 3 |
| Comparator | Active comparator | 1 capsule lactase and 1 capsule placebo, once a day, one week Receives: Dietary Supplement: Active 1; Dietary Supplement: Placebo |
| Placebo | Placebo comparator | 2 capsules placebo, once a day, one week Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one week
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
Measured: one week
Secondary outcomes (30)
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
Measured: one week
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
Measured: one week
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
Measured: Day 1
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
Measured: Day 1
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
Measured: Day 1
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
Measured: Day 1
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
Measured: one week
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
Measured: one week
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
Measured: one week
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
Measured: one week
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
Measured: Day 1
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
Measured: Day 1
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
Measured: Day 1
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
Measured: Day 1
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
Measured: one week
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
Measured: one week
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
Measured: one week
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
Measured: one week
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
Measured: Day 1
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
Measured: Day 1
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
Measured: Day 1
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
Measured: Day 1
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
Measured: one week
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
Measured: one week
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
Measured: one week
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
Measured: one week
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
Measured: Day 1
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
Measured: Day 1
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
Measured: Day 1
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
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start20 Nov 2023
- Primary completion10 Jul 2024
- Study completion10 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lactose IntoleranceStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novozymes A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Analyze & Realize
- Responsible party
- Sponsor
- Investigators
- Liana Vismane, MD, Principal investigator, analyze & realize GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06107088
- Sponsor's protocol ID
- NZ-2021-11
- Other IDs
- NOZ-DK/021121
- Status last verified
- Jul 2024
- First submitted
- 24 Oct 2023
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof-of-concept Study to Evaluate the Effect and the Tolerability of a Novel Combination of Lactase Enzyme and Ligilactobacillus Salivarius DSM 34078 in Individuals With Lactose Intolerance
- ClinicalTrials.gov ID
- NCT06107088
- Acronym / sponsor ID
- NZ-2021-11
- Conditions
- Lactose Intolerance
- Keywords
- lactase, Ligilactobacillus salivarius, lactose intolerance, hydrogen breath test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Novozymes A/SIndustry (pharma, biotech, devices)
- Collaborators
- Analyze & Realize
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- 10 Jul 2024 (actual)
- Study completion
- 10 Jul 2024 (actual)
- First posted
- 30 Oct 2023 (actual)
- 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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Test product1 | Experimental | Dietary Supplement: Active 2, Dietary Supplement: Placebo1 capsule 'lactase-bacterial strain combination' and 1 capsule placebo, once a day, one week |
| Test product2 | Experimental | Dietary Supplement: Active 1, Dietary Supplement: Active 31 capsule lactase and 1 capsule bacterial strain, once a day, one week |
| Comparator | Active comparator | Dietary Supplement: Active 1, Dietary Supplement: Placebo1 capsule lactase and 1 capsule placebo, once a day, one week |
| Placebo | Placebo comparator | Dietary Supplement: Placebo2 capsules placebo, once a day, one week |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Men and women from 18 to 65 years old
- Self-reported:
- 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)
- Generally in good health as per investigator's judgement
- Subject's ability and agreement to comply with study procedures, in particular:
Key exclusion criteria (27 listed)
- Self-reported known allergy or hypersensitivity to any components of the investigational products and/or chlorhexidine and/or standardised on-site meal
- Self-reported congenital lactase deficiency (CLD)
- Self-reported galactosemia
- 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)
- Self-reported inexplicable weight loss (>5%) within the last 3 months prior to study
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 |
|---|---|---|
| Active 1lactase enzyme | Dietary supplement | Comparator, Test product2 |
| Active 2lactase-bacterial strain combination | Dietary supplement | Test product1 |
| Active 3bacterial strain alone | Dietary supplement | Test product2 |
| Placeboplacebo | Dietary supplement | Comparator, Placebo, Test product1 |
Primary outcome
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)
Time frame: one week
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
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)
Time frame: one week
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
30 secondary outcomes
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)
Time frame: one week
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)
Time frame: one week
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)
Time frame: Day 1
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)
Time frame: Day 1
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)
Time frame: Day 1
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)
Time frame: Day 1
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)
Time frame: one week
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)
Time frame: one week
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)
Time frame: one week
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)
Time frame: one week
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)
Time frame: Day 1
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)
Time frame: Day 1
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)
Time frame: Day 1
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)
Time frame: Day 1
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)
Time frame: one week
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)
Time frame: one week
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)
Time frame: one week
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)
Time frame: one week
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)
Time frame: Day 1
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)
Time frame: Day 1
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)
Time frame: Day 1
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)
Time frame: Day 1
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)
Time frame: one week
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)
Time frame: one week
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)
Time frame: one week
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)
Time frame: one week
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)
Time frame: Day 1
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)
Time frame: Day 1
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)
Time frame: Day 1
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)
Time frame: Day 1
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 16 Jul 2024.
- Individual participant dataSharing planned: No
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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.
Liana Vismane, MD principal investigator
analyze & realize GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active 1, Active 2 and Active 3 in people with Lactose Intolerance, run by Novozymes A/S 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 18 inclusion and 27 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 16 Jul 2024. 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?
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) (time frame: one week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jul 2024.