GlyCare™ 2FL Overview

Currently, GlyCare™ 2FL is commercially available for use in infant formula, baby and kids nutrition and supplements as well as general digestive health applications in the following products:  

  • GlyCare™ 2FL 9000 - Premium crystallized powder
  • GlyCare™2FL 9000HA - Hypoallergenic, Crystallized powder
  • GlyCare™ 2FL 9000KfP - Kosher for Passover, Crystallized powder  
<p>Immunity and Infections</p>

Immunity and Infections

HMOs help support immunity. Clinical studies have reported a relationship between HMOs and some immune outcomes in infants. Emerging science suggest that specific HMOs at the correct level of supplementation may help to reduce the risk of certain infections in infants consuming infant formula and in infants who are breastfed. 

In two separate clinical studies, supplementing infant formula with HMOs; the addition of 2’FL plus galacto-oligosaccharide (GOS) or 2’FL plus LNnT were reported to help support the immune system.  The clinical trial, supplementing infant formula with 2’FL + LNnT reported a reduction in the incidence of certain (parent-reported) infections and illnesses. This included significantly fewer reports of lower respiratory tract infections; and a significant reduction in the use of anti-fever medication, and antibiotics during the first 12 months of life (2). In the second clinical study, supplementing  IF with GOS and 2’FL, a reduction in incidence of infection was reported (3). Further analysis of the cohort revealed a significant decrease in respiratory tract infections (4). Also, the 2’FL supplemented formula group reported modulation of cytokine expression to that more closely resembling the breast fed group (5).

Observational study data from breast fed infants may suggest an additional immunological benefit associated with 2’FL.  Those infants consuming breastmilk with higher levels of 2’FL compared to those with lower levels were reported to have reduced rates of moderate to severe diarrhea from any cause (6). Also, a high ratio of 2-linked oligosaccharides (vs. only 3- and 4- linked) was associated with a decreased risk of diarrhea from any cause, including moderate-to-severe diarrhea from enterotoxigenic E. coli (7).

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<p>Gut Health and Microbiota</p>

Gut Health and Microbiota

Clinical and preclinical studies report that HMOs may help to stimulate the growth of beneficial bacteria, which are believed to be important for development of the microbiota and gut health. 

A clinical trial of infant formula supplemented with 2’FL and LNnT reported an increase in the population of bifidobacteria and an infant fecal microbiota more closely resembling that of a breast fed infant (2,8). Moreover the 2’FL + LNnT supplemented group was also reported to help bring the intestinal microbiota of those infants born by C-section closer to that observed in infants born vaginally, from the control group (8). At 2 months of age significantly softer stools were reported in the 2’FL+ LNnT group (2).

Observational study data from breast fed infants indicate that rates of moderate-to-severe diarrhea from any cause diarrhea from C. jejuni, and diarrhea from Campylobacter were reduced in infants who consumed breast milk with higher levels of 2’FL compared to those consumed lower levels (6). Also a high ratio of 2-linked oligosaccharides (versus only 3- and 4- linked) was associated with a decreased risk of diarrhea from any cause, including moderate-to-severe diarrhea from enterotoxigenic E. coli (7). 

Preclinical studies also indicate 2’FL may help to stimulate the growth of beneficial bacteria (9,10,11) and contribute to normal gut barrier function (12,13)

<p>Brain and Cognitive Development</p>

Brain and Cognitive Development

Emerging science from observational study data in the breastfed infant and preclinical data in rodent models may suggest a potential role for 2’FL in brain and cognitive development. Data from a study of breast fed infants indicated the 2’FL concentration of breast milk at 1 month of age was associated with higher infant cognitive development scores at 24 months of age (14). A number of preclinical studies in rodent models provide potential mechanisms of action for 2’FL in cognitive development and function (15,16,17).

<p>Hypoallergenicity</p>

Hypoallergenicity

A clinical study of infants and children ages 2 months - 4 years of age with cow’s milk protein allergy who received an extensively hydrolyzed whey based formula, with 2’FL and LNnT (18) has been shown to meet the American Academy of Pediatrics criteria for hypoallergenicity.

Note that hypoallergenicity at levels above those studied (1.0 g/L and 0.5 g/L) may need to be assessed.

<p>Allergy Development</p>

Allergy Development

A clinical study and observational study data from breastfed infants and preclinical data suggest that 2'FL may play a role in beneficially changing the response to allergens.

A clinical trial compared supplementation of an infant formula with galacto-oligosaccharide (GOS) with and without the addition of 2’FL.  The parent reported data indicated a significantly higher percentage of infants with eczema in the group which did not receive 2’FL supplementation (19).  Observational study data also indicated that infants born by C-section with a high risk for allergies, when fed breastmilk with 2’FL had a lower risk of eczema at 2 years of age  (19).  

References

1. Erney, R. M., et al.,  2000. J Pediatr Gastroenterol Nutr: 30, 181-92. 

2. Puccio, G. et al., (2017). Effects of infant formula with human milk oligosaccharides on growth and morbidity: a randomized multicenter trial.  JPGN 64: 624-31.

3. Marriage, B., Buck, R. B., Goehring, K.C, Oliver, J.S, and Williams, J.A, (2015). Infants Fed a Lower Calorie Formula With 2’FL Show Growth and 2’FL Uptake Like Breast-Fed Infants. JPGN 61 (6), 649 – 658. doi: 10.1097/MPG.0000000000000889.

4. Reverri, E.J. et al., (2018). Review of the clinical experiences of feeding infants formula containing the human milk oligosaccharide 2’-fucosyllactose. Nutrients, 10: 1346.

5. Goehring et al., (2016). Similar to those who are breastfed, infants fed a formula containing 2’-fucosyllactose have lower inflammatory cytokines in a randomized controlled trial.  J. Nutr. 146: 2559-66.

6. Morrow et al., (2004). Human milk oligosaccharides are associated with protection against diarrhea in breast-fed infants.  J Pediatrics, 145: 297-303.

7. Newburg et al., (2004). Human milk a1,2-linked fucosylated oligosaccharides decrease risk of diarrhea due to stable toxin of E. coli in breastfed infants.  Adv Exp Med Biol, 554: 457-461.

8. Berger, B et al., (2020). Linking human milk oligosaccharides, infant fecal community types, and later risk to require antibiotics.  mBio 11: e03196-19.

9. Yu, Z. T., Chen, C., Kling, D. E., Liu, B., McCoy, J. M., Merighi, M., … Newburg, D. S. (2013). The principal fucosylated oligosaccharides of human milk exhibit prebiotic properties on cultured infant microbiota. Glycobiology, 23(2), 169–177. https://doi.org/10.1093/glycob/cws138 

10. Krista Salli, Heli Anglenius, Johanna Hirvonen, Ashley A. Hibberd, Ilmari Ahonen, Markku T. Saarinen, Kirsti Tiihonen, Johanna Maukonen, A. C. O. (2019). The effect of 2′-fucosyllactose on simulated infant gut microbiome and metabolites; a pilot study in comparison to GOS and lactose. Scientific Reports. Retrieved from https://doi.org/10.1038/s41598-019-49497-z 

11. Azagra-Boronat, I., Massot-Cladera, M., Knipping, K., van‘t Land, B., Tims, S., Stahl, B., … Rodríguez-Lagunas, M. J. (2019). Oligosaccharides Modulate Rotavirus-Associated Dysbiosis and TLR Gene Expression in Neonatal Rats. Cells, 8(8), 876. https://doi.org/10.3390/cells8080876 

12. Kong, C., Elderman, M., Cheng, L., de Haan, B. J., Nauta, A., & de Vos, P. (2019). Modulation of Intestinal Epithelial Glycocalyx Development by Human Milk Oligosaccharides and Non-Digestible Carbohydrates. Molecular Nutrition and Food Research, 63(17). https://doi.org/10.1002/mnfr.201900303 

13. Holscher, H. D., Bode, L., & Tappenden, K. A. (2017). Human Milk Oligosaccharides Influence Intestinal Epithelial Cell Maturation in Vitro. Journal of Pediatric Gastroenterology and Nutrition, 64(2), 296–301. https://doi.org/10.1097/MPG.0000000000001274 

14. Berger PK, Plows JF, Jones RB, et al. Human milk oligosaccharide 2'-fucosyllactose links feedings at 1 month to cognitive development at 24 months in infants of normal and overweight mothers. PLoS One. 2020;15(2):e0228323. Published 2020 Feb 12. doi:10.1371/journal.pone.0228323

15. Vázquez, E., Barranco, A., Ramírez, M., Gruart, A., Delgado-García, J. M., Martínez-Lara, E., … Rueda, R. (2015). Effects of a human milk oligosaccharide, 2′-fucosyllactose, on hippocampal long-term potentiation and learning capabilities in rodents. Journal of Nutritional Biochemistry, 26(5), 455–465. https://doi.org/10.1016/j.jnutbio.2014.11.016 

16. Oliveros, E., Ramirez, M., Vazquez, E., Barranco, A., Gruart, A., Delgado-Garcia, J. M., … Martin, M. J. (2016). Oral supplementation of 2’-fucosyllactose during lactation improves memory and learning in rats. Journal of Nutritional Biochemistry, 31, 20–27. https://doi.org/10.1016/j.jnutbio.2015.12.014 

17. Vazquez, E., Barranco, A., Ramirez, M., Gruart, A., Delgado-Garcia, J. M., Jimenez, M. L., … Rueda, R. (2016). Dietary 2′-fucosyllactose enhances operant conditioning and long-term potentiation via gut-brain communication through the vagus nerve in rodents. PLoS ONE, 11(11), 1–14. https://doi.org/10.1371/journal.pone.0166070 

18. Nowak-Wegrzyn et al., (2019). Confirmed hypoallergenicity of a novel whey-based extensively hydrolyzed infant formula containing two human milk oligosaccharides.  Nutrients 11: 1447.

19. Sprenger et al.,  (2017). FUT2-dependent breast milk oligosaccharides and allergy at 2 and 5 years of age in infants with high hereditary allergy risk.  Eur J Nutr., 56: 1293-1301.

 

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