Objective: Infant constipation is a frequent condition in formula-fed infants.
Methods: A prospective randomized clinical trial was performed in infants who had constipation with Novalac-IT (IT group) versus a 20% strengthened formula (S group). Enrolled subjects had difficulties in defecating, hard stools, or low frequency of defecation (< or =3 times/wk).
Results: Ninety-three infants (47 boys, mean age 3.8 +/- 1.7 mo) were included because of hard consistency of (50.5%), low frequency in (44.1%), or painful (33.3%) defecation. A statistically significant improvement was observed after 4 and 8 wk of intervention in the IT group (P = 0.014 and P < 0.001, respectively). In the IT group, significantly more infants were symptom free at 4 wk (82.9% versus 50%, P = 0.029) and at 8 wk (89.1% versus 54.1%, P < 0.001). Increased stool weight was significant in the IT group after 4 and 8 wk (P = 0.048 and 0.029).
Conclusion: Novalac-IT decreases constipation in formula-fed infants.