Study on the Efficacy and Tolerance of a New Anti-regurgitation Infant Formula (STELLAR)

Study Overview
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Brief Summary
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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
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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).

Official Title
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Study on the Efficacy and Tolerance of a New Anti-regurgitation Infant Formula: a Double-blind, Randomized, Controlled, International, Multi-centric Clinical Trial

Conditions
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Gastroesophageal Reflux in Children

Intervention / Treatment
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* Other: Experimental Infant formula
* Other: Infant formula thickened with locust bean gum


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Weeks
Maximum Age: 4 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test<br>new thickened infant formula containing fibres | Other: Experimental Infant formula<br>* Exclusive formula feeding with the new infant formula thickened with fibers<br>|
| Active Comparator: Control<br>infant formula thickened with locust bean | Other: Infant formula thickened with locust bean gum<br>* Exclusive formula feeding with the formula thickened with locust bean<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of regurgitation | Decrease of the daily number of regurgitation between baseline and day 14 | Day 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Reflux