NCT02518295

β-galactosidase Producing Probiotic Strains to Improve Lactose Digestion

β-galactosidase Producing Probiotic Strains to Improve Lactose Digestion: Probiotic and Lactose Intolerance

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Société des Produits Nestlé (SPN) · Industry
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess that two β-galactosidase Producing Probiotic Strains help improve lactose digestion in subjects with lactose maldigestion.

Detailed description

The trial will be cross over, randomized in incomplete blocks, controlled, double-blind: each subject will be administered 3 products out of 4 (positive control, probiotic Streptococcus (S.) thermophilus, probiotic Bifidobacterium (B.) longum, negative control) in a random order on 3 different days separated by a washout period of at least one week, and maximum 2 weeks between each challenge. The total sample size is 42 enrolled subjects/37 completed Patients will be males and females aged between 20 and 65 years with positive hydrogen breath test.

Conditions

• Lactose Intolerance

Interventions

Type	Name	Description
OTHER	Positive control	200ml milk containing 18g lactose
OTHER	Probiotic S. thermophilus	200ml milk containing 18g lactose + probiotic S. thermophilus
OTHER	Probiotic B. longum	200ml milk containing 18g lactose + probiotic B. longum
OTHER	Negative control	200 ml of UHT Lactose free milk

Timeline

• Start date: 2015-09-01
• Primary completion: 2016-06-01
• Completion: 2016-09-01
• First posted: 2015-08-07
• Last updated: 2016-11-30

Locations

1 site across 1 country: Switzerland