NCT02519374

Fiber Tolerability in Children

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Société des Produits Nestlé (SPN) · Industry
• Sex: All
• Age: 8 Years – 12 Years
• Healthy volunteers: Accepted

Summary

Assessment of the digestive tolerability of the PROMITOR® .

Detailed description

The trial will be multicenter, double-blind, placebo-controlled, randomized with a 4-arm parallel-design. The subjects wil be randomized to one of the four arms, i.e. four doses of investigational product balanced in maltodextrin, given at the doses of 6, 9 or 12 g (corresponding to 4, 6, or 8 g of fibers) twice a day with the meals of the morning and of the evening versus control (maltodextrin, no fibers) over one week of intake. The total sample size is 40 healthy children from 8 to 12 years old, male and female.

Conditions

• Signs and Symptoms, Digestive

Interventions

Type	Name	Description
DRUG	Placebo (including Maltodextrin)
DRUG	PROMITOR® (including Maltodextrin)	Investigational product dose 1
DRUG	PROMITOR® (including Maltodextrin)	Investigational product dose 2
DRUG	PROMITOR® (including Maltodextrin)	Investigational product dose 3

Timeline

• Start date: 2015-06-01
• Primary completion: 2015-07-01
• Completion: 2015-08-01
• First posted: 2015-08-10
• Last updated: 2016-02-05

Locations

2 sites across 2 countries: France, Switzerland