NCT03659747

Effect of Probiotic Supplementation on Lactose Maldigestion Induced by Fat-free Milk

Effect of Probiotic Supplementation on Lactose Maldigestion Induced by Fat-free Milk: Randomized, Double-blind, Placebo-controlled, Crossover, Acute Lactose Challenge

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Danisco · Industry
• Sex: All
• Age: 25 Years – 60 Years
• Healthy volunteers: Not accepted

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))

Conditions

• Gastrointestinal Symptoms
• Breath Test

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotic	\- 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.
DIETARY_SUPPLEMENT	Lactrase	\- 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.
OTHER	Placebo	\- 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.

Timeline

• Start date: 2018-09-11
• Primary completion: 2018-12-21
• Completion: 2018-12-21
• First posted: 2018-09-06
• Last updated: 2019-03-05

Locations

1 site across 1 country: Germany