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

HMO (2’-FL) when added to infant feed is well tolerated : A Randomized Controlled Trial

Background

Human milk oligosaccharides (HMOs) are the third major component of human milk. Approximately 162 HMOs have been identified in breast milk. 2′-Fucosyllactose (2′-FL) is an HMO occurring in great predominance in human milk. Research suggests that HMOs are an essential component for development of the infant’s immunity. 2’-FL functions as a prebiotic against pathogens to modulate cellular immune responses. 2’-FL is also found to help in improving stool consistency and promoting softer stools.

Aim

To evaluate feed tolerance of an infant feed with HMO (2′-FL) along with probiotic Bifidobacterium Animalis ssp lactis strain (B. lactis), as compared to similar formula without 2′-FL.

Study Design

A randomized, controlled, double-blind multi-centre trial consisting of healthy, full-term singleton infants, ages 14 ± 5 days who had been exclusively formula-fed for at least 3 days prior to enrolment. A total of 78 infants (mean age 14 ± 5 days) were enrolled in the study. The subjects were assigned to one of the two feeding groups for 6 weeks.

Subjects & Feed composition

Primary outcome measures

1. Infant Gastrointestinal Symptom Questionnaire (IGSQ) Score between day zero and day 42 (6 weeks)

Secondary outcome measures

1. Stool Frequency, Consistency, and Ease of Passing
2. Formula Intake
3. Anthropometrics
4. Spit Up, Vomiting, Crying and Fussing
5. Adverse Events

Results and Discussions

Primary Outcome:

1. Infant Gastrointestinal Symptom Questionnaire (IGSQ): After 6 weeks the IGSQ score of test and control group were similar.

Secondary Outcome:

1. Stool Consistency, Frequency, and Ease of Passing: Stools of infants fed the Test feed were soft 77% of the time (Figure 1.). Stool frequency did not differ between groups. Control group reported difficulty to pass stools (p = 0.04) as compared to test group.







2. Adverse Event: No adverse effects were reported in either group. However, control group reported more subjects with infections and infestations (p = 0.05). Suggesting a positive association of 2’-FL and lower rate of infection in the test group. This suggests that 2’-FL supports development of immune function brining it similar to breastfed infants.
3. Similar response was observed among the test and control group for Infant Gastrointestinal Symptom Questionnaire (IGSQ), Formula Intake, Anthropometrics (weight and length), Spit Up, Vomiting, Crying and Fussing.