Status:
UNKNOWN
Study on the Efficacy and Tolerance of a New Anti-regurgitation Infant Formula (STELLAR)
Lead Sponsor:
United Pharmaceuticals
Collaborating Sponsors:
Statitec
Conditions:
Gastroesophageal Reflux in Children
Eligibility:
All Genders
2-4 years
Phase:
NA
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...
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 ...
Eligibility Criteria
Inclusion
- ≥ 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
- 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
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2022
Estimated Enrollment :
346 Patients enrolled
Trial Details
Trial ID
NCT04358146
Start Date
July 1 2020
End Date
March 1 2022
Last Update
April 24 2020
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