NCT06107088

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Novozymes A/S · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Active 1	lactase enzyme
DIETARY_SUPPLEMENT	Active 2	lactase-bacterial strain combination
DIETARY_SUPPLEMENT	Active 3	bacterial strain alone
DIETARY_SUPPLEMENT	Placebo	placebo

Timeline

• Start date: 2023-11-20
• Primary completion: 2024-07-10
• Completion: 2024-07-10
• First posted: 2023-10-30
• Last updated: 2024-07-16

Locations

1 site across 1 country: Germany