Effect of Probiotic Supplementation on Lactose Maldigestion Induced by Fat-free Milk
Condition: Gastrointestinal Symptoms; Breath Test
Study type: Interventional

Summary: 
      The main objective of the study is to investigate the effect of probiotic supplementation on
      lactose maldigestion.
    

Detailed description: 
      Primary endpoint is defined as the difference in breath hydrogen concentration (BHC, ppm) in
      lactase and probiotic groups compared to placebo and non-inferiority in breath hydrogen
      concentration (BHC, ppm) in probiotic group compared to lactase group, measured by the
      incremental area under curve (iAUC) analysis.

      To characterize the benefit of the investigational product (IP) the following secondary
      endpoints will be analyzed:

      Breath test:

        -  Breath hydrogen peak value (ppm) in lactase and probiotic groups compared to placebo

        -  Cumulative breath hydrogen (ppm) in lactase and probiotic groups compared to placebo

      Acute gastrointestinal symptoms (severity or presence/absence to be defined on a Likert
      scale) in lactase and probiotic groups compared to placebo:

        -  Abdominal pain

        -  Flatulence

        -  Bloating

        -  Nausea and vomiting

        -  Bowel movements and diarrhea (if present, stool consistency to be defined on Bristol
           stool scale and number of bowel movements to be recorded)

      Ancillary:

        -  Baseline fasting BHC (ppm)

        -  Breath methane (CH4; ppm)

        -  Breath carbon dioxide (CO2; ppm)

        -  Probiotic identification in feces before each lactose challenge by molecular methods

        -  Gene test to determine lactase deficiency status at V1 (following single nucleotide
           polymorphism (SNP) variants to be screened: -13910*C (Europe, Central Asia, commonly
           used) -13915*T (Saudi-Arabia, Africa), -14010*C (Africa), -13907*C (Africa))
    

Intervention name(s): Probiotic; Lactrase; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Other
Intervention description(s): - 6 g sachet containing probiotic powder (1.8 x 10^12 CFU Probiotic) in sachet - One sachet of the investigational product will be consumed with 521 ml of Weihenstephan fat-free milk once in the beginning of a 6-hour challenge at a study visit.; - 6 g sachet containing 4500 Food Chemical Codex (FCC) units of lactase (Lactrase, Oy Verman Ab, Kerava, Finland) and maltodextrin as a carrier - One sachet of the investigational product will be consumed with 521 ml of Weihenstephan fat-free milk once in the beginning of a 6-hour challenge at a study visit.; - 6 g sachet containing placebo powder (maltodextrin) in sachet - One sachet of the investigational product will be consumed with 521 ml of Weihenstephan fat- free milk once in the beginning of a 6-hour challenge at a study visit.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Crossover Assignment Randomized, double-blind, placebo-controlled, parallel-group study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Lactose maldigestion; gastrointestinal; Single-nucleotide polymorphism; probiotic