Growth, stool consistency and bone mineral content in healthy term infants fed sn-2-palmitate-enriched starter infant formula: A randomized, double-blind, multicentre clinical trial.

BACKGROUND: Palmitate in breast milk is predominantly located in the triacylglycerol sn-2 position, while infant formulae contain palmitate predominantly in the sn-1 and sn-3 positions. During digestion, palmitate in the sn-1 and sn-3 positions is hydrolyzed to free palmitic acid that can subsequently complex with calcium to form insoluble soaps; this may partially explain why formula-fed infants have harder stools than breast-fed infants. METHODS: This large (n = 488) randomized, double-blind, multicentre trial investigated whether increasing the sn-2 palmitate content of infant formula improves stool consistency and bone mineral content (measured by dual-energy x-ray absorptiometry), without affecting growth or health. From ∼1 week to 4 months of age, infants were exclusively fed one of three formulae: i) control formula (CF; 16% of total palmitate at sn-2; n = 162), (ii) experimental formula 1 (EF1; 43% of total palmitate at sn-2; n = 166) or (iii) experimental formula 2 (EF2; 51% of total palmitate at sn-2; n = 160). RESULTS: Intention-to-treat analysis showed softer stools in both EF groups (vs. CF) at ages 2 weeks and 1 and 2 months (p ≤ 0.01), but not 3 and 4 months. At 4 months, all groups had similar growth outcomes while bone mineral content was significantly higher in EF1 (p = 0.0012) and EF2 (p = 0.0002) compared with CF. Comparison of reported adverse events up to 12 months revealed no differences among groups. All 3 infant formulae exhibited equally good digestive tolerance. CONCLUSIONS: Formulae enriched in sn-2 palmitate fed in early infancy are safe, improve stool consistency (from 2 weeks to 2 months) and increase bone mineral content (at 4 months).

Adequacy and safety of an infant formula with a protein/energy ratio of 1.8 g/100 kcal and enhanced protein efficiency for term infants during the first 4 months of life.

OBJECTIVE: Excess protein in infant formula may lead to renal overload and play a role in later obesity. The objective of this controlled, prospective, randomized, double-blind study was to assess the suitability and safety of a modified protein content infant formula and its noninferiority as compared to a conventional formula. PATIENTS AND METHODS: Healthy term infants age < 7 days were either breast-fed or randomized to be fed exclusively with a conventional casein-predominant formula (protein/energy ratio: 2.6 g/100 kcal) or the isocaloric whey-predominant study formula (protein/energy ratio: 1.8 g/100 kcal) for 120 days. Primary outcome was daily weight gain between D0 and D120 (noninferiority criterion: difference in daily weight gain < or = 4 g). Secondary outcomes were daily gain in weight, length, head circumference and body mass index at monthly intervals. Tolerance and safety were assessed at each visit. RESULTS: 162 infants were enrolled, 84% of the formula-fed infants and 36% of the breast-fed infants completing the study. Mean daily weight gain from D0 to D120 in the formula-fed groups differed by 0.38 g/day [95% CI: -2.59; 1.83] signifying the noninferiority of the study formula. Secondary outcomes did not differ between the 2 groups at any time and were comparable to outcomes in the breast-fed group. Tolerance was good and adverse events were not different between study groups. CONCLUSIONS: The whey-predominant study infant formula with a protein/energy ratio of 1.8 g/100 kcal and enhanced protein efficiency is safe and not inferior to a conventional formula in ensuring normal growth during the first four months of life.

Incidence and risk factors of oral antibiotic-associated diarrhea in an outpatient pediatric population.

BACKGROUND: Little information is available on the epidemiologic characteristics of antibiotic-associated diarrhea (AAD) in children. The authors' aim was to evaluate the incidence of AAD in an outpatient pediatric population and to identify risk factors. METHODS: Children aged 1 month to 15.4 years treated with oral antibiotics for a proven or suspected infection were enrolled from an ambulatory pediatric practice during an 11-month period. Parents recorded the daily frequency and characteristics of stools using a diary during the antibiotic treatment and for 1 week after it was stopped. An episode of diarrhea was defined by at least 3 soft or liquid stools/d for at least 2 consecutive days. Risk factors for AAD-age, type of antibiotic treatment, type of combined treatment, and site of infection-were analyzed. RESULTS: Of 650 children included, 11% had an episode of AAD, lasting a mean of 4.0 +/- 3.0 days, beginning a mean of 5.3 +/- 3.5 days after the start of antibiotic treatment. No child was hospitalized because of AAD. The incidence of AAD was higher in children less than 2 years (18%) than in those more than 2 years (3%; P < 0.0001). The incidence of AAD was particularly high after administration of certain antibiotics (amoxicillin/clavulanate, 23%; P = 0.003 compared with other antibiotics). The type of combined treatment and site of infection did not influence the onset of AAD. CONCLUSIONS: Antibiotic-associated diarrhea was common in these outpatient children, especially for those aged less than 2 years and after the prescription of certain antibiotics, particularly, the combination of amoxicillin/clavulanate.