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

Gastrointestinal Symptoms Clinical Trial

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

Status Completed

Clinical Trial Summary

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

Clinical Trial 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)) ;

Related Conditions & MeSH terms

• Breath Test
• Gastrointestinal Symptoms

• NCT number: NCT03659747
• Study type: Interventional
• Source: Danisco
• Status: Completed
• Phase: N/A
• Start date: September 11, 2018
• Completion date: December 21, 2018