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
![grow-graph](/prebiotics/images/table(Storm 2012).png)
Primary outcome measures
- Infant Gastrointestinal Symptom Questionnaire (IGSQ) Score between day zero and day 42 (6 weeks)
Secondary outcome measures
- Stool Frequency, Consistency, and Ease of Passing
- Formula Intake
- Anthropometrics
- Spit Up, Vomiting, Crying and Fussing
- Adverse Events
Results and Discussions
Primary Outcome:
- Infant Gastrointestinal Symptom Questionnaire (IGSQ): After 6 weeks the IGSQ score of test and control group were similar.
Secondary Outcome:
- 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.
- 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.
- 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.
![grow-graph](/prebiotics/images/graph(Storm 2012).png)
Conclusion
HMO (2’-FL) when added to infant feed is well tolerated. Additionally, 2’-FL improves stool consistency, ease of passing stools and supports the developing immune function in infants.
Reference
Heidi M. Storm, et al. 2′-Fucosyllactose Is Well Tolerated in a 100% Whey, Partially Hydrolyzed Infant Formula With Bifidobacterium lactis: A Randomized Controlled Trial. Global Pediatric Health Volume 6: 1–10. Published online 2019 Mar 15.