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Evaluation of the Efficacy of a New Specific Infant Formula in Case of Functional Constipation

Functional Constipation Clinical Trial

Official title:
Evaluation of the Efficacy of a New Specific Infant Formula With a Prebiotic and Probiotics in Case of Functional Constipation

Clinical Trial Summary

This study aims to assess the clinical efficacy, safety and tolerance of a new formula containing a prebiotic and a mix of probiotics in the specific population of infants suffering from functional constipation through a superiority, double-blind, randomized, placebo-controlled trial.

Clinical Trial Description

The study comprises a selection period of 1 week where the eligibility of the infant to participate in the study will be evaluated. Once his/her participation is confirmed, the tested formula will be compared to a standard formula during a 2-month study period followed by an optional follow-up period of 2 months where only the tested formula will be used. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05340712
Study type Interventional
Source United Pharmaceuticals
Contact Anne-Sophie Garreau
Phone 0033-155372222
Email as.garreau@novalac.com
Status Recruiting
Phase N/A
Start date July 20, 2022
Completion date September 2024
View Details
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