NCT02677090

Fiber Tolerability in Children Aged 3-7 Year

Fiber Tolerability In Children Aged 3-7 Year

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Société des Produits Nestlé (SPN) · Industry
• Sex: All
• Age: 3 Years – 7 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Signs and Symptoms, Digestive

Interventions

Type	Name	Description
DRUG	Placebo (including Maltodextrin)
DRUG	Dose 1 - Promitor®
DRUG	Dose 2 - Promitor®
DRUG	Dose 3 - Promitor®

Timeline

• Start date: 2016-01-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2016-02-09
• Last updated: 2016-03-10

Locations

1 site across 1 country: France