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

Phase 3

Completed

• Conditions: Gastroesophageal Reflux
• Interventions: Dietary Supplement: New thickened formula

• Registration Number: NCT02425423
• Lead Sponsor: United Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Primary Completion: 2014-03
• Study Completion: 2014-06
• Status Verified: 2015-04
• Study First Submitted: 2015-04-20
• Study First Submitted QC: 2015-04-23
• Last Update Submitted: 2015-04-23
• Study First Posted: 2015-04-24
• Last Update Posted: 2015-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
New thickened infant formula	New thickened formula	-

Primary Outcome Measures

Name	Time	Method
Number of episodes of regurgitation per day	14 days

Secondary Outcome Measures

Name	Time	Method
Regurgitation score	3 months
Growth parameters (Weight, height and head circumference)	3 months	Weight, height and head circumference
Digestive tolerance (stools' number and consistency)	3 months	Digestive tolerance of the formula assessed through stools' number and consistency

Trial Locations

Locations (2)

Pediatricians; 🇫🇷 France, France

Universitair Ziekenhuis; 🇧🇪 Brussel, Belgium