CompletedNot Applicable

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

Germany76 participantsStarted 2023-11-20

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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:
. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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)

Timeframe: 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)

Timeframe: one week

Trial details

NCT IDNCT06107088

SponsorNovozymes A/S

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-07-10

View on ClinicalTrials.gov More Lactose Intolerance trials

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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:
. 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

What they're measuring

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)

Timeframe: 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)

Timeframe: one week

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria