2'-Fucosyllactose Is Well Tolerated in a 100% Whey, Partially Hydrolyzed Infant Formula With Bifidobacterium lactis: A Randomized Controlled Trial.

Human milk oligosaccharides are important components of breast milk. We evaluated feeding tolerance of the human milk oligosaccharide 2'-fucosyllactose (2'FL) in a 100% whey, partially hydrolyzed infant formula with the probiotic Bifidobacterium animalis ssp lactis strain Bb12 (B lactis; Test) as compared with the same formula without 2'FL (Control) in a randomized controlled trial of healthy infants enrolled at 2 weeks of age (±5 days). After 6 weeks of feeding the assigned formula, the primary outcome of tolerance was assessed using the Infant Gastrointestinal Symptom Questionnaire. Stooling, vomiting, spit-up, crying, and fussing were compared between groups. Seventy-nine infants were enrolled and 63 completed the study per protocol (30 Test, 33 Control). Infant Gastrointestinal Symptom Questionnaire scores were similar between groups (Test 20.9 ± 4.8, Control 20.7 ± 4.3, P = .82). Partially hydrolyzed infant formula with 2'FL and B lactis is tolerated well, as confirmed by a validated multi-symptom index.

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

OBJECTIVE: This study's 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.

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.