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

NCT03659747 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2019-03-05

No results posted yet for this study

Summary

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

Conditions

  • Gastrointestinal Symptoms
  • Breath Test

Interventions

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.

Sponsors & Collaborators

  • Analyze & Realize

    collaborator NETWORK

  • Danisco

    lead INDUSTRY

Principal Investigators

  • Ralf Uebelhack, Prof. MD · analyze & realize GmbH

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
25 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-11
Primary Completion
2018-12-21
Completion
2018-12-21

Countries

  • Germany

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 NCT03659747 on ClinicalTrials.gov