Back to resultsSWAN: Study on the Tolerance and Efficacy of a New Anti-regurgitation Formula (PC-2016-01) (SWAN)
Primary Purpose
Gastroesophageal Reflux
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Thickened infant formula
Sponsored by
About this trial
This is an interventional treatment trial for Gastroesophageal Reflux
Eligibility Criteria
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
Sites / Locations
- Universitair Ziekenhuis
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Thickened infant formula
Arm Description
Outcomes
Primary Outcome Measures
Number of episodes of regurgitation per day
Secondary Outcome Measures
Regurgitation score assessed through Vandenplas score
Stools frequency over 72h
Stools consistency assessed through Bristol Stool form Scale
Weight expressed in z scores according to the WHO Child Growth Standards
Height expressed in z scores according to the WHO Child Growth Standards
BMI expressed in z scores according to the WHO Child Growth Standards
Head circumference expressed in z scores according to the WHO Child Growth Standards
Full Information
NCT ID
NCT02710955
First Posted
March 8, 2016
Last Updated
November 13, 2017
Sponsor
United Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT02710955
Brief Title
SWAN: Study on the Tolerance and Efficacy of a New Anti-regurgitation Formula (PC-2016-01)
Acronym
SWAN
Official Title
Study on the Tolerance and Efficacy of a New Anti-regurgitation Formula (PC-2016-01)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
April 1, 2016 (undefined)
Primary Completion Date
January 21, 2017 (Actual)
Study Completion Date
April 12, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
United Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to evaluate the efficacy of a new thickened formula on regurgitation
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Thickened infant formula
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Thickened infant formula
Primary Outcome Measure Information:
Title
Number of episodes of regurgitation per day
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Regurgitation score assessed through Vandenplas score
Time Frame
14 and 90 days
Title
Stools frequency over 72h
Time Frame
14 and 90 days
Title
Stools consistency assessed through Bristol Stool form Scale
Time Frame
14 and 90 days
Title
Weight expressed in z scores according to the WHO Child Growth Standards
Time Frame
90 days
Title
Height expressed in z scores according to the WHO Child Growth Standards
Time Frame
90 days
Title
BMI expressed in z scores according to the WHO Child Growth Standards
Time Frame
90 days
Title
Head circumference expressed in z scores according to the WHO Child Growth Standards
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Week
Maximum Age & Unit of Time
5 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yvan Vandenplas, MD
Organizational Affiliation
Universitair Ziekenhuis Brussel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitair Ziekenhuis
City
Brussels
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
SWAN: Study on the Tolerance and Efficacy of a New Anti-regurgitation Formula (PC-2016-01)
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