Clinical Trial: β-galactosidase Producing Probiotic Strains to Improve Lactose Digestion

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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 Summary:

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.

Sponsor: Nestlé

Current Primary Outcome: Lactose malabsorption as represented by the increase of exhaled hydrogen compared to baseline measured by the hydrogen Breath Test (HBT) [ Time Frame: HBT measured every hour during 4 hours after challenge (HBT curve) ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Assessment of improvement of lactose intolerance symptoms using a composite score equal to the sum of individual symptoms measured using a visual analog scale (VAS) [ Time Frame: 4 hours after every milk intake, from the time of ingestion up to 5 hours ]

Original Secondary Outcome: Same as current

Information By: Nestlé

Dates:
Date Received: July 16, 2015
Date Started: September 2015
Date Completion:
Last Updated: November 29, 2016
Last Verified: November 2016