Study on the Tolerance and Efficacy of a New Anti Regurgitation Formula
Phase 3
Completed
- Conditions
- Gastroesophageal Reflux
- 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
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
- 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
Pediatricians🇫🇷France, France