A Double-Blinded, Prospective Trial with A New Formula in Distressed and Regurgitating Infants

ABSTRACT

Infant regurgitation and distress are common but are a major cause of parental anxiousness. The efficacy of dietary management is contradictory.

Twelve exclusively formula fed infants crying for more than 3 hours/day since at least 3 weeks and regurgitating several times after each feeding were enrolled in a double blinded cross-over intervention trial with two innovative formulas (“G1” and “G3”), both developed by Novalac. Prior to inclusion, all infants had been put on at least three different commercialized AR-formulae and/or formulae for digestive comfort and at least one extensive hydrolysate without improvement. All infants had been treated unsuccessfully with prokinetics (domperidone or cisapride) and acidblocking drug medication (H􀀁 receptor antagonists and/or generic omeprazole and/or alginates).

One formula (“G3”) scored significantly better than the other, resulting in a significant decrease in regurgitation and crying, an overall subjective well-being amelioration of the baby and enhanced gastric emptying. All 12 mothers preferred the same test formula, despite the cross-over and blinded design. Stool patterns and aspect with “G3” was comparable to defecation in breast fed infants.

Although the number of infants is limited, one of the test formulas, G3, combining a specific partial whey hydrolysate with a combination of thickeners (bean gum and specially processed tapioca starch) was a) effective in alleviating the symptoms where other thickened and extensively hydrolyzed formulas as well as prokinetics and acid blocking drugs had failed and b) more effective than the other tested formula combining 2 thickeners (locust bean and starch) widely used in anti-regurgitation formulas, G1.