Study on the Tolerance and Efficacy of a New Anti Regurgitation Formula

Phase 3CompletedNCT02425423

United Pharmaceuticals100 enrolled

Overview

The aim of this study is to evaluate the efficacy of a new thickened formula on regurgitation.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Gastroesophageal Reflux

Interventions

New thickened formulaDIETARY_SUPPLEMENT

Eligibility

Sex: ALLMax age: 5 Months

Medical Language ↔ Plain English

Inclusion Criteria: Infants : * Aged ≤ 5 months old * fully formula fed * with at least 5 episodes of regurgitation per day Exclusion Criteria: * Breast fed infants * Infants presenting symptoms of a complicated gastroesophageal reflux * Infants presenting intestinal disorders

Locations (3)

Pediatricians

Belgium, Belgium

Universitair Ziekenhuis

Brussels, Belgium

Pediatricians

France, France

Outcomes

Primary Outcomes

Number of episodes of regurgitation per day

Time frame: 14 days

Secondary Outcomes

Regurgitation score

Time frame: 14 days

Regurgitation score

Time frame: 3 months

Digestive tolerance (stools' number and consistency)

Digestive tolerance of the formula assessed through stools' number and consistency

Time frame: 14 days

Digestive tolerance (stools' number and consistency)

Digestive tolerance of the formula assessed through stools' number and consistency

Time frame: 3 months

Growth parameters (Weight, height and head circumference)

Weight, height and head circumference

Time frame: 3 months

Data from ClinicalTrials.gov

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