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

NCT06107088 | Completed DMC

• 2 other identifiers: NZ-2021-11NOZ-DK/021121
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lactose Intolerance

Keywords

lactase; Ligilactobacillus salivarius; lactose intolerance; hydrogen breath test

Outcome Measures

Primary Outcomes (2)

• 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

  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

  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)

  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)

  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)

  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)

  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)

  Day 1

Study Arms (4)

Test product1

EXPERIMENTAL

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

Dietary Supplement: Active 2; Dietary Supplement: Placebo

Test product2

EXPERIMENTAL

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

Dietary Supplement: Active 1; Dietary Supplement: Active 3

Comparator

ACTIVE COMPARATOR

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

Dietary Supplement: Active 1; Dietary Supplement: Placebo

Placebo

PLACEBO COMPARATOR

2 capsules placebo, once a day, one week

Dietary Supplement: Placebo

Interventions

Active 1 DIETARY_SUPPLEMENT

lactase enzyme

Comparator; Test product2

Active 2 DIETARY_SUPPLEMENT

lactase-bacterial strain combination

Test product1

Active 3 DIETARY_SUPPLEMENT

bacterial strain alone

Test product2

Placebo DIETARY_SUPPLEMENT

placebo

Comparator; Placebo; Test product1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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.)

Sponsors & Collaborators

• Novozymes A/S: lead
• Analyze & Realize: collaborator

Study Sites (1)

Analyze & Realize Study Center

Berlin, Germany

Location

MeSH Terms

Conditions

Lactose Intolerance

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Liana Vismane, MD

  analyze & realize GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2023
• First Posted: October 30, 2023
• Study Start: November 20, 2023
• Primary Completion: July 10, 2024
• Study Completion: July 10, 2024
• Last Updated: July 16, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)