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Effect of Probiotic Supplementation on Lactose Maldigestion Induced by Lactose Solution

NCT03814668 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2019-08-13

No results posted yet for this study

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

DIETARY_SUPPLEMENT

Probiotic

Intake of probiotic

DIETARY_SUPPLEMENT

Lactase

Intake of lactase

OTHER

Placebo

Intake of placebo

Sponsors & Collaborators

  • Danisco

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-11-05
Primary Completion
2019-04-30
Completion
2019-04-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03814668 on ClinicalTrials.gov