2′-Fucosyllactose Is Well Tolerated in a 100% Whey, Partially Hydrolyzed Infant Formula WithBifidobacterium lactis: A Randomized Controlled Trial

Abstract

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.

Clinical Evaluation of 16-Week Supplementation with 5HMO-Mix in Healthy-Term Human Infants to Determine Tolerability, Safety, and Effect on Growth

“…Over the last two decades, efforts have been made to synthesize HMOs and add them to formula products, but only a limited number of HMOs not representing all structural classes have been tested in the clinic. These earlier studies investigated the safety, tolerability, and effect on growth of 2′-FL [ 42 , 43 , 44 ], 2′-FL plus LNnT [ 45 , 54 ], or 2′-FL plus 3′-galactosyllactose (3′-GL) [ 46 ], typically combined with other prebiotics [ 42 , 43 , 46 ] such as galacto-oligosaccharides (GOS) and fructo-oligosaccharides (FOS) or probiotics [ 46 , 54 ].…”

“…SAEs causally linked to the IF products were diagnosed as allergy to bovine milk protein. Studies investigating the use of 2′-FL in a formula with partly or fully hydrolyzed milk protein have already demonstrated that those formulae are safe and well tolerated [ 44 , 46 , 64 ]. Although hematochezia was more frequently reported in the 5HMO-Mix group, the overall frequency was still very low, and there were no specific safety concern indicators.…”

“…Thus, in this study, we chose concentrations of HMOs that reflected an average of reported physiological HMO concentrations in human breast milk, with a slightly increased proportion of LNT to promote growth of beneficial intestinal bacteria. Thus far, clinical studies have been carried out with 2′-FL or mixtures of two HMOs [ 42 , 43 , 44 , 45 , 46 ], but to the best of our knowledge there have been no clinical studies published on the tolerance and safety of HMO mixtures containing multiple HMOs from all three classes.…”

Use of a Partially Hydrolyzed 100% Whey-Based Infant Formula with Lactobacillus Reuteri in Infants with Caregiver-Perceived Intolerance

“…Therefore changes in the overall combined score can be reflective of differences in any singular domain, or more likely, in any combination thereof. This tool has been validated and used in several infant formula studies [18][19][20][21] . It is administered in a standardized way by trained personnel but answered by caregivers, providing an objective score for comparing an infant's GI symptoms.…”

“…At the final visit, the IGSQ score was assumed to be 33 (reduction by 5 points) with a standard deviation again of 8. Estimates of the correlation between the baseline and final IGSQ scores were derived from a previous study using the same base infant formula 19 . Assuming the most conservative (i.e.…”