The main objective of the study is to investigate the effect of probiotic supplementation on lactose maldigestion.
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))
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
34
\- 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.
analyze & realize GmbH
Berlin, Germany
Difference in breath hydrogen concentration (BHC, ppm) in probiotic group compared to placebo, measured by the iAUC analysis
Time frame: approximately 40 days
Difference in breath hydrogen concentration (BHC, ppm) in lactase group compared to placebo, measured by the iAUC analysis
Time frame: approximately 40 days
Non-inferiority in breath hydrogen concentration (BHC, ppm) of probiotic group compared to lactase group (positive control), measured by the iAUC analysis
Time frame: approximately 40 days
Difference in breath hydrogen concentration (BHC, ppm) in lactase group compared to placebo, measured by breath hydrogen peak value
Time frame: approximately 40 days
Difference in breath hydrogen concentration (BHC, ppm) in probiotic group compared to placebo, measured by breath hydrogen peak value
Time frame: approximately 40 days
Difference in breath hydrogen concentration (BHC, ppm) in lactase group compared to placebo, measured by cumulative breath hydrogen value
Time frame: approximately 40 days
Difference in breath hydrogen concentration (BHC, ppm) in probiotic group compared to placebo, measured by cumulative breath hydrogen value
Time frame: approximately 40 days
Difference in the presence of diarrhea in lactase group compared to placebo, as defined by the gastrointestinal symptom survey
Time frame: approximately 40 days
Difference in the presence of diarrhea in probiotic group compared to placebo, as defined by the gastrointestinal symptom survey
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Time frame: approximately 40 days
Difference in the severity of abdominal pain in lactase group compared to placebo, as defined by the gastrointestinal symptom survey
Time frame: approximately 40 days
Difference in the severity of abdominal pain in probiotic group compared to placebo, as defined by the gastrointestinal symptom survey
Time frame: approximately 40 days
Difference in the severity of flatulence in lactase group compared to placebo, as defined by the gastrointestinal symptom survey
Time frame: approximately 40 days
Difference in the severity of flatulence in probiotic group compared to placebo, as defined by the gastrointestinal symptom survey
Time frame: approximately 40 days
Difference in the severity of bloating in lactase group compared to placebo, as defined by the gastrointestinal symptom survey
Time frame: approximately 40 days
Difference in the severity of bloating in probiotic group compared to placebo, as defined by the gastrointestinal symptom survey
Time frame: approximately 40 days
Difference in the severity of nausea in lactase group compared to placebo, as defined by the gastrointestinal symptom survey
Time frame: approximately 40 days
Difference in the severity of nausea in probiotic group compared to placebo, as defined by the gastrointestinal symptom survey
Time frame: approximately 40 days
Difference in the presence of vomiting in lactase group compared to placebo, as defined by the gastrointestinal symptom survey
Time frame: approximately 40 days
Difference in the presence of vomiting in probiotic group compared to placebo, as defined by the gastrointestinal symptom survey
Time frame: approximately 40 days
Difference in the presence of bowel movements in lactase group compared to placebo, as defined by the gastrointestinal symptom survey
Time frame: approximately 40 days
Difference in the presence of bowel movements in probiotic group compared to placebo, as defined by the gastrointestinal symptom survey
Time frame: approximately 40 days