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.
≥ 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
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)
Parallel
Experimental Infant formula
Other interventionExclusive formula feeding with the new infant formula thickened with fibers
Infant formula thickened with locust bean gum
Other interventionExclusive formula feeding with the formula thickened with locust bean
Frequency of regurgitation
Decrease of the daily number of regurgitation between baseline and day 14
Frequency of regurgitations
Change in the daily number of regurgitation between baseline and day 30 / day 90
Severity of regurgitation episodes
Severity of regurgitations will be assessed using the adapted Vandenplas' score (range: 0 to 6; higher scores indicate more severe regurgitation)
Stools' frequency
Average daily stool's number
Stools' consistency
The Amsterdam Infant Stool Scale (AISS) (consistency categories: A \[watery\] to D \[hard\]; higher categories indicate firmer stools)
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United Pharmaceuticals
Lead sponsor
Statitec
Collaborator
