Effect of Probiotic Supplementation on Lactose Maldigestion Induced by Lactose Solution

Lactose Intolerance Clinical Trial

Official title: 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

Clinical Trial 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))

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Lactose Intolerance

• NCT number: NCT03814668
• Study type: Interventional
• Source: Danisco
• Status: Completed
• Phase: N/A
• Start date: November 5, 2018
• Completion date: April 30, 2019