Heidi Storm

Growth and Tolerance of Term Infants Fed Formula With Probiotic Lactobacillus reuteri

Background. Lactobacillus reuteri has been studied for its safety and beneficial effects in infants. This study assessed growth of infants fed a partially hydrolyzed whey formula with L reuteri. Methods. Healthy term infants were randomized to 1 of 2 formulas (partially hydrolyzed whey formula with (PRO) or without (CON) L reuteri from 14 to 112 days of age. Anthropometric measures were assessed at 14, 28, 56, 84, and 112 days of age. Tolerance records were completed 2 days prior to each visit. Results. A total of 122 subjects completed study per protocol (60 PRO, 62 CON). No differences were seen in daily weight gain, length, or head circumference. Overall, between groups, there were no significant differences in formula intake, stool frequency, color, consistency, flatulence, frequency of spit-up/vomiting, mood, sleep, or incidence of adverse events. Conclusion. Infants fed probiotic formula had similar growth to infants fed control formula. Both formulas were well tolerated.

A Randomized Controlled Trial Assessing Growth of Infants Fed a 100% Whey Extensively Hydrolyzed Formula Compared With a Casein-Based Extensively Hydrolyzed Formula

This study compared the growth of healthy infants fed a hypoallergenic 100% whey-based extensively hydrolyzed formula (EHF) with Bifidobacterium lactis (test) with that of infants fed an extensively hydrolyzed casein formula (control). Formula-fed infants (14 ± 3 days) were randomized to test or control groups until 112 days of age. Anthropometrics were assessed at 14, 28, 56, 84, and 112 days, and daily records were kept for 2 days prior to study visits. Serum albumin and plasma amino acids at 84 days were assessed in a subset. A total of 282 infants were randomized (124 test, 158 control). Significantly more infants dropped out of the control (56%) as compared with the test (41%) group. Mean daily weight gain was significantly higher in the test group compared with the control group (27.95 ± 5.91 vs 25.93 ± 6.12 g/d; P = .027) with the test group reporting significantly fewer stools (2.2 vs 3.6 stools/d; P < .0001). The control group reported significantly more days with >3 loose stools/d and a higher incidence of vomiting as compared with the test group. There were no differences in gas, mood, sleep, or serum albumin. Plasma arginine and valine were significantly lower in the test group, whereas leucine and lysine were higher; all values were within normal limits. Significantly more adverse events attributed to the study formula were reported in the control group. The 100% whey-based hypoallergenic EHF containing Bifidobacterium lactis and medium chain triglycerides supported growth of healthy infants. Future studies on the application of this formula in clinically indicated populations are warranted.

Formula Switch Leads to Enteral Feeding Tolerance Improvements in Children With Developmental Delays

Background: Children with developmental delays are often dependent on enteral nutrition. The aim of our study was to evaluate improvement in tolerance parameters in these children who were switched from an intact protein formula to a 100% whey, peptide-based formula. Methods: A retrospective chart review of children with developmental delays who were failing to reach adequate nutritional goals on standard polymeric formulas were switched to a 100% whey peptide-based formula. Enteral volume goals, caloric goals, and change in medication used to improve feeding tolerance were assessed before and after formula switch. Results: Medical records of 13 children (aged 8.4 ± 4.6 years) met criteria. All children had a primary diagnosis of developmental delay, and 77% were fed via gastrostomy tube. Of the 13 children assessed, 92% experienced improved feeding tolerance, and 75% of these reported the time to improvement within 1 week after formula switch. Feeding tolerance parameters that improved were vomiting (86%), gagging and retching (75%), high residual volumes (63%), constipation (43%), diarrhea (100%), and poor weight gain (100%). Conclusion: Switching to a 100% whey, peptide-based formula improved symptoms of feeding intolerance in the majority of these developmentally delayed children.

Assessment of Growth of Infants Fed an Amino Acid-Based Formula

Objective This studys primary aim was to compare the growth (daily weight gain) of infants consuming a new (Test) amino acid-based formula (AAF) or a commercially available AAF (Control). Methods Healthy infants were randomized to Test or Control from 14 to 112 days of age. Anthropometric measurements were taken at 14,28, 56, 84, and 112 days of age. Tolerance records were completed prior to each visit. Serum albumin and plasma amino acids were ascertained in a subset of infants at 84 days of age. Results A total of 119 subjects completed the study per protocol. Mean daily weight gains were 27.26 ± 4.92 g/day for Control and 27.42 ± 6.37 g/day for Test (P = 0.8812). There were no significant differences between groups in formula intake, adverse events, flatulence, spit-up/vomiting, mood, or sleep. Albumin and plasma amino acids were within normal limits for both groups. Conclusions Infants fed the new AAF had similar daily weight gains as infants fed a commercially available AAF.

Hypoallergenicity of a New Extensively Hydrolyzed 100% Whey-based FormulaContaining Probiotics

Objective: The American Academy of Pediatrics (AAP) defined an infant formula as hypoallergenic if it ensures with 95% confidence that 90% of infants/children with confirmed cow’s milk protein allergy (CMA) do not react under double-blind, placebo-controlled conditions. The aim of this study was to determine whether a new 100% whey protein extensively hydrolyzed formula containing B. lactis CNCM I-3446, meets AAP hypoallergenicity criteria. Methods: Children with CMPA were randomized to double-blind placebo-controlled food challenges (DBPCFC) with a new extensively hydrolyzed formula (Test) and a commercial extensively hydrolyzed formula (Control) in a cross-over fashion. CMPA was confirmed by elevated serum cow’s milk (CM)-IgE levels, positive skin prick test to CM extract, or positive CM oral challenge within 6 months prior to enrollment. Allergic reactions in the DBPCFC’s were assessed using a comprehensive scoring system. If both challenges were tolerated, subjects participated in an at-home week-long Test open challenge. Results: Seventy-seven children (3.30 ± 2.98 years old) with recently confirmed CMPA were enrolled. Of the 68 subjects participating in the Test DBPCFC, one had an allergic reaction (lower bound 95% confidence interval of 0.921 for Test), while 4 out of 75 subjects participating in the DBPCFC with Control had an allergic reaction. The Test formula met the AAP hypoallergenicity criteria. Average formula intake during the Test open challenge was 250ml/ day. One 6-year old subject reported angioedema, atopic dermatitis, rash around the eyes, and red swollen eyes on open challenge Day 6. This subject did not report any symptoms during the Test DBPCFC, was not exclusively formula-fed during the open challenge, and did not discontinue formula during the open challenge. Conclusion: The new Test EHF meets the AAP criteria for hypoallergenicity and can be recommended for the management of CMPA.