Therapeutic effect of Novalac-IT in infants with constipation.
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).


CONCLUSIONS
Novalac-IT decreases constipation in formula-fed infants.
Chao
Hsun-Chin
HC
Division of Gastroenterology, Department of Pediatrics, Chang Gung Children's Hospital, Chang Gung Memorial Hospital, Chang Gung University Medical College, Taoyuan, Taiwan. hero@adm.cgmh.org.tw
Vandenplas
Yvan
Y
D003248:Constipation / Q000178:diet therapy*; D003672:Defecation / Q000187:drug effects* / Q000502:physiology; D005260:Female; D005772:Gastrointestinal Transit / Q000187:drug effects* / Q000502:physiology; D006801:Humans; D007223:Infant; D041943:Infant Formula / Q000008:administration & dosage / Q000737:chemistry; D008274:Magnesium / Q000494:pharmacology / Q000627:therapeutic use*; D008297:Male; D011446:Prospective Studies; D016896:Treatment Outcome
D008274:Magnesium