SWAN: Study on the Tolerance and Efficacy of a New Anti-regurgitation Formula (PC-2016-01)
Not Applicable
Completed
- Conditions
- Gastroesophageal Reflux
- Interventions
- Dietary Supplement: Thickened infant formula
- Registration Number
- NCT02710955
- 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, for at least a week
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 Thickened infant formula Thickened infant formula -
- Primary Outcome Measures
Name Time Method Number of episodes of regurgitation per day 14 days
- Secondary Outcome Measures
Name Time Method Stools frequency over 72h 14 and 90 days Stools consistency assessed through Bristol Stool form Scale 14 and 90 days Weight expressed in z scores according to the WHO Child Growth Standards 90 days Height expressed in z scores according to the WHO Child Growth Standards 90 days Regurgitation score assessed through Vandenplas score 14 and 90 days BMI expressed in z scores according to the WHO Child Growth Standards 90 days Head circumference expressed in z scores according to the WHO Child Growth Standards 90 days
Trial Locations
- Locations (1)
Universitair Ziekenhuis
🇧🇪Brussels, Belgium