THE HUMAN MILK OLIGOSACCHARIDE, 2’FUCOSYLLACTOSE, IS WELL TOLERATED IN A 100% WHEY, PARTIALLY HYDROLYZED INFANT FORMULA

BACKGROUND AND AIMS: Human milk oligosaccharides (HMOs), like 2’fucosyllactose (2’FL), provide breastfed infants immunological advantages.  Tolerance data from randomized trials do not exist on 2’FL in 100% whey, partially hydrolyzed formulas (PHF-W) or on formulas containing a probiotic.  The primary objective of this multicenter, double-blind study was to compare tolerance using the Infant Gastrointestinal Symptom Questionnaire (IGSQ) between infants fed a PHF-W with 2’FL and Bifidobacterium lactis (B.lactis; Test) and infants fed PHF-W with B.lactis without 2’FL (Control). 
METHODS: Following informed consent by caregivers, healthy formula-fed infants ages 14 ± 5 days were randomized to receive Test or Control formulas.  The IGSQ was conducted at enrollment and after 6 weeks of feeding.  Secondary outcomes (stool characteristics, spit-up, vomiting, fussing, crying) were captured on diaries by caregivers.  Adverse events (AE) and caregiver formula satisfaction were also reported. Adverse events were classified into System, Organ, and Class categories.
RESULTS: 79 infants were enrolled, and 63 completed the study per protocol (PP). IGSQ scores at the end of the study in the PP population were similar between Test (20.9 ± 4.8) and Control groups (20.7 ± 4.3) (p= 0.82).  Stool consistency, vomiting, fussing, spit-up occurrence and crying did not differ between groups.  AEs were similar between groups; however there was a trend toward fewer infections in Test (p=0.05). 97% of PP infants were perceived to be comfortable on both formulas.  
CONCLUSION:    2'FL in PHF-W with B.lactis is well tolerated and may help support the developing immune system in infants.