Back to resultsStudy on the Efficacy and Tolerance of a New Anti-regurgitation Infant Formula (STELLAR) (STELLAR)
Primary Purpose
Gastroesophageal Reflux in Children
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Experimental Infant formula
Infant formula thickened with locust bean gum
Sponsored by
About this trial
This is an interventional treatment trial for Gastroesophageal Reflux in Children focused on measuring Reflux
Eligibility Criteria
Inclusion Criteria:
- ≥ 2 regurgitation episodes per day during the last 2 weeks and ≥ 4 regurgitation episodes per day in average during the last 2 days,
- exclusive or predominant formula feeding
- whose parents signed informed consent
Exclusion Criteria:
- preterm infants or birthweight <2500g
- Post enteritis lactose intolerance
- Suspected or diagnosed cow's milk protein allergy requiring an eviction diet
- Use of medications that may interfere with regurgitation or gastrointestinal transit (such as alginates, laxatives, antibiotics...). All these medications have to be stopped at least 7 days before inclusion visit (V1)
- Infants presenting with any situation which, according to the investigator, may interfere with the study participation, or lead to a particular risk for the subject
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Test
Control
Arm Description
new thickened infant formula containing fibres
infant formula thickened with locust bean
Outcomes
Primary Outcome Measures
Frequency of regurgitation
Decrease of the daily number of regurgitation between baseline and day 14
Secondary Outcome Measures
Full Information
NCT ID
NCT04358146
First Posted
April 21, 2020
Last Updated
April 21, 2020
Sponsor
United Pharmaceuticals
Collaborators
Statitec
1. Study Identification
Unique Protocol Identification Number
NCT04358146
Brief Title
Study on the Efficacy and Tolerance of a New Anti-regurgitation Infant Formula (STELLAR)
Acronym
STELLAR
Official Title
Study on the Efficacy and Tolerance of a New Anti-regurgitation Infant Formula: a Double-blind, Randomized, Controlled, International, Multi-centric Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2020 (Anticipated)
Primary Completion Date
January 1, 2022 (Anticipated)
Study Completion Date
March 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
United Pharmaceuticals
Collaborators
Statitec
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The aim of the study is to assess the effectiveness of this new formula on regurgitations and secondarily its effect on digestive tolerance through a randomized, controlled, double-blind trial against a comparator.
Detailed Description
The study duration is 1 month and 2 days. It is possible to add 2 additional months (optional).
The 2 first days (from D-3 to D0) correspond to the pre-selection period. These 2 days are followed by the follow-up month (from D0 to D30). It is possible to add an optional follow up of 2 months (form D30 to D90).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux in Children
Keywords
Reflux
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
346 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Test
Arm Type
Experimental
Arm Description
new thickened infant formula containing fibres
Arm Title
Control
Arm Type
Active Comparator
Arm Description
infant formula thickened with locust bean
Intervention Type
Other
Intervention Name(s)
Experimental Infant formula
Intervention Description
Exclusive formula feeding with the new infant formula thickened with fibers
Intervention Type
Other
Intervention Name(s)
Infant formula thickened with locust bean gum
Intervention Description
Exclusive formula feeding with the formula thickened with locust bean
Primary Outcome Measure Information:
Title
Frequency of regurgitation
Description
Decrease of the daily number of regurgitation between baseline and day 14
Time Frame
Day 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Weeks
Maximum Age & Unit of Time
4 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
≥ 2 regurgitation episodes per day during the last 2 weeks and ≥ 4 regurgitation episodes per day in average during the last 2 days,
exclusive or predominant formula feeding
whose parents signed informed consent
Exclusion Criteria:
preterm infants or birthweight <2500g
Post enteritis lactose intolerance
Suspected or diagnosed cow's milk protein allergy requiring an eviction diet
Use of medications that may interfere with regurgitation or gastrointestinal transit (such as alginates, laxatives, antibiotics...). All these medications have to be stopped at least 7 days before inclusion visit (V1)
Infants presenting with any situation which, according to the investigator, may interfere with the study participation, or lead to a particular risk for the subject
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bastian CUMINAL
Phone
0033155372222
Email
b.cuminal@novalac.com
First Name & Middle Initial & Last Name or Official Title & Degree
ANNE-SOPHIE GARREAU
Email
as.garreau@novalac.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandra Papadopoulou
Organizational Affiliation
University of Athens, Athens Children's Hospital "AGIA SOFIA"
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Study on the Efficacy and Tolerance of a New Anti-regurgitation Infant Formula (STELLAR)
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