The clinical effect of a new infant formula in term infants with constipation: a double-blind, randomized cross-over trial.
BACKGROUND
Nutrilon Omneo (new formula; NF) contains high concentration of sn-2 palmitic acid, a mixture of prebiotic oligosaccharides and partially hydrolyzed whey protein. It is hypothesized that NF positively affects stool characteristics in constipated infants.


METHODS
Thirty-eight constipated infants, aged 3-20 weeks, were included and randomized to NF (n = 20) or a standard formula (SF; n = 18) in period 1 and crossed-over after 3 weeks to treatment period 2. Constipation was defined by at least one of the following symptoms: 1) defecation frequency < 3/week; 2) painful defecation; 3) abdominal or rectal palpable mass.


RESULTS
Period 1 was completed by 35 infants. A significant increase in defecation frequency (NF: 3.5 pre versus 5.6/week post treatment; SF 3.6 pre versus 4.9/week post treatment) was found in both groups, but was not significantly different between the two formulas (p = 0.36). Improvement of hard stool consistency to soft stool consistency was found more often with NF than SF, but did not reach statistical significance (90% versus 50%; RR, 1.8; 95% CI, 0.9-3.5; p = 0.14). No difference was found in painful defecation or the presence of an abdominal or rectal mass between the two groups. Twenty-four infants completed period 2. Only stool consistency was significantly different between the two formulas (17% had soft stools on NF and hard stools on SF; no infants had soft stools on SF and hard stools on NF, McNemar test p = 0.046).


CONCLUSIONS
The addition of a high concentration sn-2 palmitic acid, prebiotic oligosaccharides and partially hydrolyzed whey protein resulted in a strong tendency of softer stools in constipated infants, but not in a difference in defecation frequency. Formula transition to NF may be considered as treatment in constipated infants with hard stools.
Bongers
Marloes E J
ME
Department of Pediatric Gastroenterology and Nutrition, Emma Children's Hospital, Academic Medical Centre, Amsterdam, The Netherlands. mbongers@amc.uva.nl
de Lorijn
Fleur
F
Reitsma
Johannes B
JB
Groeneweg
Michael
M
Taminiau
Jan A J M
JA
Benninga
Marc A
MA
D003248:Constipation / Q000503:physiopathology / Q000628:therapy*; D018592:Cross-Over Studies; D003672:Defecation / Q000502:physiology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007223:Infant; D041943:Infant Formula / Q000737:chemistry*; D007231:Infant, Newborn; D007785:Lactose / Q000008:administration & dosage; D019787:Linoleic Acid / Q000008:administration & dosage; D008297:Male; D008894:Milk Proteins / Q000008:administration & dosage; D015999:Multivariate Analysis; D009844:Oligosaccharides / Q000008:administration & dosage / Q000737:chemistry; D019308:Palmitic Acid / Q000008:administration & dosage / Q000737:chemistry*; D016896:Treatment Outcome; D000067816:Whey Proteins
D008894:Milk Proteins; D009844:Oligosaccharides; D000067816:Whey Proteins; D019308:Palmitic Acid; D019787:Linoleic Acid; D007785:Lactose