The clinical effect of a new infant formula in term infants with constipation: a double-blind, randomized cross-over trial

Abstract

BackgroundNutrilon 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.MethodsThirty-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.ResultsPeriod 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).ConclusionThe 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.

Tolerance and Efficacy of Infant Formula with High Sn-2 Palmitate in Formula-Fed Chinese Term Infants: an Open Label, Controlled Trial

“…Similar to results from previous studies [14,17,24], our breastfed infants had higher frequency of stools and softer stools than the formula fed infants. The complexity of human milk composition is not entirely understood.…”

The Effect of Lactobacillus reuteri Supplementation in Adults with Chronic Functional Constipation: a Randomized, Double-Blind, Placebo-Controlled Trial*

“…Also, in our patients, L. reuteri improved stool consistency, even if without a statistically signi cant di erence compared to placebo, probably due to the limited time of treatment. One possible explanation could be the enhanced water and electrolyte secretion due to probiotic activity that may so en the stools [18,19].…”

The bifidogenic effect of inulin and oligofructose and its consequences for gut health

“…Recent data from studies with infants show that oligofructose increases stool frequency (Euler et al, 2005) and/or leads to softer stools (Moore et al, 2003;Bongers et al, 2007), whereas inulin consumption in formula-fed babies had a positive effect on stool mass at a consumption of about 1.5 g/day with a trend for softer consistency (Kim et al, 2007). The same effects have been reported for the GOS/FOS mixture, as described by Knol et al (2005).…”