NCT03814668

Effect of Probiotic Supplementation on Lactose Maldigestion Induced by Lactose Solution

Effect of Probiotic Supplementation on Lactose Maldigestion Induced by Lactose Solution: Randomized, Double-blind, Placebo-controlled, Positive-controlled, Three-way Crossover, Acute Lactose Challenge

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Danisco · Industry
• Sex: All
• Age: 25 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Study objectives: Primary: Difference in breath hydrogen concentration (BHC, ppm) in lactase and probiotic groups compared to placebo, measured by the incremental area under curve (iAUC) analysis Non-inferiority in breath hydrogen concentration (BHC, ppm) of probiotic group compared to lactase group, measured by the incremental area under curve (iAUC) analysis Secondary: 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 screening (following SNP variants to be screened: 13910\*C (Europe, Central Asia, commonly used) -22018\*G (Europe), -13915\*T (Saudi-Arabia, Africa), -14010\*G (Africa), -13907\*C (Africa))

Conditions

• Lactose Intolerance

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotic	Intake of probiotic
DIETARY_SUPPLEMENT	Lactase	Intake of lactase
OTHER	Placebo	Intake of placebo

Timeline

• Start date: 2018-11-05
• Primary completion: 2019-04-30
• Completion: 2019-04-30
• First posted: 2019-01-24
• Last updated: 2019-08-13

Locations

1 site across 1 country: France