Study on the Efficacy and Tolerance of a New Anti-regurgitation Infant Formula (STELLAR)
Recruiting
N/A
Interventional Study
Gastroesophageal Reflux in Children
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 2 Weeks – 4 Months
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 346 (estimated)
- Sponsor
- United Pharmaceuticals · Industry
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About This Trial
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.
Trial Locations
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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 \<2500…
Contacts