NCT01717534

Children Immune Functions

A Randomized, Double-blind, Placebo-controlled Study to Investigate the Effect of Heat-treated Lactobacilli on Infections and Immune Status in Healthy Children

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 374 (actual)
• Sponsor: Société des Produits Nestlé (SPN) · Industry
• Sex: All
• Age: 12 Months – 48 Months
• Healthy volunteers: Accepted

Summary

The purpose of the planned study is to investigate the effect of heat-treated lactobacilli on diarrhea outcome in healthy children 1-4 years old in a randomized, double-blind, placebo-controlled study.

Detailed description

The beneficial effect of heat-treated lactobacilli for treatment of symptomatic diarrhea was clearly documented and the purpose of this planned study is to investigate the effect on reduction of days with diarrhea in a preventive setting in healthy children 1-4 years old. Moreover, the study is intended to evaluate the impact on the immune status of the children.

Conditions

• Diarrhea
• Upper Respiratory Infections

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	heat-treated lactobacilli or placebo	Daily supplement of sachet with 1 g of powder over a 5 months period.

Timeline

• Start date: 2012-10-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2012-10-30
• Last updated: 2013-08-27

Locations

2 sites across 1 country: Mexico