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

Not Applicable

Completed

• Conditions: Gastroesophageal Reflux

• 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

Study Timeline

• Study First Submitted: 2016-03-08
• Study First Submitted QC: 2016-03-11
• Study First Posted: 2016-03-17
• Study Start: 2016-04-01
• Primary Completion: 2017-01-21
• Study Completion: 2017-04-12
• Status Verified: 2017-05
• Last Update Submitted: 2017-11-13
• Last Update Posted: 2017-11-14

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

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