Study on the Efficacy and Tolerance of a New Anti-regurgitation Infant Formula (STELLAR) (NCT04358146) | Clinical Trial Compass
RecruitingNot Applicable
Study on the Efficacy and Tolerance of a New Anti-regurgitation Infant Formula (STELLAR)
Belgium, France346 participantsStarted 2023-03-17
Plain-language 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.
Who can participate
Age range2 Weeks – 4 Months
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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