INTRODUCTION: Many parents seek medical help because of frequent regurgitation and inconsolable crying of their formula-fed infant.

OBJECTIVE: We aimed to assess the effectiveness of special formulas in distressed and regurgitating infants.

METHODS: We included 12 consecutive infants in a prospective, randomized, single-blinded (parents), cross-over trial (6 infants were started on G1 [80/20 casein/whey, tapioca starch, and locust bean] for 2 weeks and then switched for 2 weeks to G3 [partial whey hydrolysate, tapioca starch, and locust bean]; for the other 6 infants, the order of the formulas was opposite). Infants were exclusively formula fed, were crying for >3 hours/day for at least 3 weeks, and regurgitated several times after each feeding. Before inclusion, all of them had been given ≥3 different commercialized AR formulae, formulae for digestive comfort, and at least 1 extensive hydrolysate without success. All infants had been treated without success with a prokinetic agent (domperidone/cisapride) and an acid-blocking drug (H2-receptor agonist/proton-pump inhibitor).

RESULTS: Gastric emptying time, as evaluated with a 13C acetate breath test, was 117.1 ± 18.3 minutes with Novalac-AR (80/20 casein/whey and corn starch), 104.5 ± 15.5 minutes with G1, and 79.2 ± 14.0 minutes with G3 (P < .001 [Friedman test]). The mean number of regurgitations per day was 5.1 ± 1.2 with G1 and 1.8 ± 1.2 with G3 (P = .002). Quality of life, as assessed by the parents in a diary, was 4.20 ± 1.79 with G1 and 2.10 + 0.74 with G3 (P = .005). The mean duration of crying per day was 84.5 ± 50.1 minutes with G1 and 26.7 ± 18.1 minutes with G3 (P = .003).

CONCLUSIONS: The cross-over design protected for bias. G3 scored better than G1 for all parameters evaluated and decreased regurgitation and infant distress significantly.

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