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

Heidi M Storm, Julie Shepard, Laura M Czerkies, Brian Kineman, Sarah S Cohen, Heidi Reichert, Ryan Carvalho, Heidi M Storm, Julie Shepard, Laura M Czerkies, Brian Kineman, Sarah S Cohen, Heidi Reichert, Ryan Carvalho

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.

Keywords: 2′-fucosyllactose; gastrointestinal tolerance; human milk oligosaccharides; infant formula; partially hydrolyzed whey.

Conflict of interest statement

Declaration of Conflicting Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: HMS, LMC, BK, and RC are employees of Nestlé Nutrition, the sponsor of this study. JS, SSC, and HR are paid consultants for Nestlé Nutrition.

Figures

Figure 1.
Figure 1.
Flow diagram of subject randomization, allocation, and analytic populations.
Figure 2.
Figure 2.
Mean caregiver reported stool consistency percentages over 2-day diaries at Visit 1, intent-to-treat population.

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