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Clinical Trial Summary

Determination of the digestive tolerability of the PROMITOR® in children from 3 to 7 years old.


Clinical Trial Description

The aim of the trial is to determine, using a dose escalation design, the digestive tolerability of the PROMITOR®given at the doses of 6, then 9 and finally 12 g (corresponding to 4, 6, and 8 g of fibers respectively) twice a day with the meals of the morning and of the evening versus control (maltodextrin, no fiber) over one week of intake in children from 3 to 7 years old.

As it is an exploratory study there is no categorization between primary and secondary objectives. ;


Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)


Related Conditions & MeSH terms


NCT number NCT02677090
Study type Interventional
Source Nestlé
Contact
Status Completed
Phase N/A
Start date January 2016
Completion date March 2016

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