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Gastrointestinal Tolerance of Erythritol-containing Beverages in Young Children

NCT02016703 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 185

Last updated 2017-07-19

No results posted yet for this study

Summary

Purpose of this study: assess the maximum tolerated bolus dose of erythritol, delivered in a clear beverage, compared with placebo (saccharose) in 4-6 year old children.

Conditions

  • Gastrointestinal
  • Tolerance

Interventions

OTHER

Erythritol drink

OTHER

Placebo drink

Sponsors & Collaborators

  • Biofortis Mérieux NutriSciences

    collaborator OTHER

  • Cargill

    lead INDUSTRY

Principal Investigators

  • Evelyne Jacqz-Aigrain, PhD · Clinical Investigation Centre Robert Debré Hospital, Paris, France

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
4 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-03-31
Primary Completion
2009-07-31
Completion
2010-07-31

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 NCT02016703 on ClinicalTrials.gov