Study on the Efficacy and Tolerance of a New Anti-regurgitation Infant Formula (STELLAR)
Study on the Efficacy and Tolerance of a New Anti-regurgitation Infant Formula: a Double-blind, Randomized, Controlled, International, Multi-centric Clinical Trial
United Pharmaceuticals
346 participants
Mar 17, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- ≥ 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 Criteria5
- 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
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Interventions
Exclusive formula feeding with the new infant formula thickened with fibers
Exclusive formula feeding with the formula thickened with locust bean
Locations(12)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04358146