SWAN: Study on the Tolerance and Efficacy of a New Anti-regurgitation Formula (PC-2016-01)

N/ACompletedNCT02710955

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

Thickened infant formulaDIETARY_SUPPLEMENT

Eligibility

Sex: ALLMin age: 1 WeekMax 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, for at least a week Exclusion Criteria: * Breast fed infants * Infants presenting symptoms of a complicated gastroesophageal reflux * Infants presenting intestinal disorders

Locations (1)

Universitair Ziekenhuis

Brussels, Belgium

Outcomes

Primary Outcomes

Number of episodes of regurgitation per day

Time frame: 14 days

Secondary Outcomes

Regurgitation score assessed through Vandenplas score

Time frame: 14 and 90 days

Stools frequency over 72h

Time frame: 14 and 90 days

Stools consistency assessed through Bristol Stool form Scale

Time frame: 14 and 90 days

Weight expressed in z scores according to the WHO Child Growth Standards

Time frame: 90 days

Height expressed in z scores according to the WHO Child Growth Standards

Time frame: 90 days

BMI expressed in z scores according to the WHO Child Growth Standards

Time frame: 90 days

Head circumference expressed in z scores according to the WHO Child Growth Standards

Time frame: 90 days

Data from ClinicalTrials.gov

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