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Breakthrough of Human Milk Oligosaccharides

Breakthrough of Human Milk Oligosaccharides

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Breakthrough of Human Milk Oligosaccharides

  1. 1. Breakthrough of Human MilkBreakthrough of Human Milk OligosaccharidesOligosaccharides 18-10-201818-10-2018 Khaled Saad, MDKhaled Saad, MD Associate Professor of PediatricsAssociate Professor of Pediatrics University of Assiut School of MedicineUniversity of Assiut School of Medicine Board member of European Council for Nutritional andBoard member of European Council for Nutritional and Environmental Medicine (CONEMEnvironmental Medicine (CONEM))
  2. 2. 18-10-201818-10-2018 Breakthrough of HMO, K.SaadBreakthrough of HMO, K.Saad
  3. 3. ObjectivesObjectives  To highlight the importance of HumanTo highlight the importance of Human Milk Oligosaccharides (HMOs) onMilk Oligosaccharides (HMOs) on Growth, Immunity and Morbidity.Growth, Immunity and Morbidity. 18-10-201818-10-2018 Breakthrough of HMO, K.SaadBreakthrough of HMO, K.Saad
  4. 4. AgendaAgenda ““It’s all about Effects of Human MilkIt’s all about Effects of Human Milk Oligosaccharides on Growth,Oligosaccharides on Growth, Immunity and MorbidityImmunity and Morbidity”” 18-10-201818-10-2018 Breakthrough of HMO, K.SaadBreakthrough of HMO, K.Saad
  5. 5. IntroductionIntroduction The transition from the protectedThe transition from the protected intrauterine environment to aintrauterine environment to a world of microbes presents aworld of microbes presents a newborn with a set ofnewborn with a set of immunological demands for self-immunological demands for self- protection against pathogens.protection against pathogens. 18-10-201818-10-2018 Breakthrough of HMO, K.SaadBreakthrough of HMO, K.Saad
  6. 6.  Because the adaptive immuneBecause the adaptive immune system is impaired due to minimalsystem is impaired due to minimal pre-exposure to microbes in uteropre-exposure to microbes in utero and immature effector B- and T-and immature effector B- and T- cells, the innate immune system iscells, the innate immune system is the first-line of the newborn'sthe first-line of the newborn's defense.defense. 18-10-201818-10-2018 Breakthrough of HMO, K.SaadBreakthrough of HMO, K.Saad
  7. 7.  It consists of the physical barriersIt consists of the physical barriers and cellular and humoral immunity,and cellular and humoral immunity, which provide rapid protectionwhich provide rapid protection against pathogens withoutagainst pathogens without generating immunologic memory. Ingenerating immunologic memory. In the first three months of life, thethe first three months of life, the cellular immune system undergoescellular immune system undergoes maturation with multiple factorsmaturation with multiple factors involved.involved. 18-10-201818-10-2018 Breakthrough of HMO, K.SaadBreakthrough of HMO, K.Saad
  8. 8.  Granulocytes (mostly neutrophils),Granulocytes (mostly neutrophils), monocytes, macrophages, dendriticmonocytes, macrophages, dendritic cells, natural killer (NK) cellscells, natural killer (NK) cells together with the complementtogether with the complement system are directed to combat asystem are directed to combat a broad spectrum of invadingbroad spectrum of invading pathogens. Notably, at birth the T-pathogens. Notably, at birth the T- helper (Th) cell population is stillhelper (Th) cell population is still biased towards the Th2 phenotype.biased towards the Th2 phenotype. 18-10-201818-10-2018 Breakthrough of HMO, K.SaadBreakthrough of HMO, K.Saad
  9. 9.  This driving type-2 pathwayThis driving type-2 pathway (“humoral immunity”) critical for(“humoral immunity”) critical for the protection against extracellularthe protection against extracellular pathogens and regulation of allergicpathogens and regulation of allergic responses as opposed to theresponses as opposed to the Th1/Th17 phenotype, driving type-1Th1/Th17 phenotype, driving type-1 pathway (“cellular immunity”) forpathway (“cellular immunity”) for fighting intracellular pathogens.fighting intracellular pathogens. 18-10-201818-10-2018 Breakthrough of HMO, K.SaadBreakthrough of HMO, K.Saad
  10. 10.  This peculiarity is a result of an adaptation to avoid an alloimmune reaction between mother and fetus during the intrauterine period, which leads to a newborn's particular susceptibility to pathogens and allergy. 18-10-201818-10-2018 Breakthrough of HMO, K.SaadBreakthrough of HMO, K.Saad
  11. 11.  The gut epithelium constitutes a functional barrier which delays pathogenic invasion of the host by gut microbiota and provides active elements of the lymphoid cell line, thus modulating immune responses. 18-10-201818-10-2018 Breakthrough of HMO, K.SaadBreakthrough of HMO, K.Saad
  12. 12.  The immature neonate's intestine is characterized by overexpression of inflammatory genes and insufficient expression of genes responsible for the feed-back regulation of innate signaling, which could lead to amplification of immune responses resulting in excessive inflammation. 18-10-201818-10-2018 Breakthrough of HMO, K.SaadBreakthrough of HMO, K.Saad
  13. 13. What are HMOs?What are HMOs?  HMOs comprise a family of freeHMOs comprise a family of free oligosaccharides with high structuraloligosaccharides with high structural diversity and represent the thirddiversity and represent the third largest group of bioactive moleculeslargest group of bioactive molecules in human milk. Colostrum containsin human milk. Colostrum contains 20-25 g/L of HMOs, however, further20-25 g/L of HMOs, however, further milk production maturation ismilk production maturation is accompanied by the decrease ofaccompanied by the decrease of HMOs content to 5-20 g/L.HMOs content to 5-20 g/L. 18-10-201818-10-2018 Breakthrough of HMO, K.SaadBreakthrough of HMO, K.Saad
  14. 14. 18-10-201818-10-2018 Breakthrough of HMO, K.SaadBreakthrough of HMO, K.Saad
  15. 15.  Over 200 unique HMOs have been discovered and more than 100 have been structurally solved and characterized.  The dominant oligosaccharide in 80% of all women is 2'-fucosyllactose (2′-FL), a trisaccharide consisting of glucose, galactose, and fucose. 18-10-201818-10-2018 Breakthrough of HMO, K.SaadBreakthrough of HMO, K.Saad
  16. 16.  To date, there have been two large, international analyses of HMOs in human milk [Erney et al. J. Pediatr. Gastroenterol. Nutr. 2000, 30, 181–192, and McGuire et al. Am. J. Clin. Nutr. 2017, 105, 1086– 1100 ]. 18-10-201818-10-2018 Breakthrough of HMO, K.SaadBreakthrough of HMO, K.Saad
  17. 17.  The first comprehensive analysis of HMOs from human milk in approximately 400 lactating women from 10 countries found that 85% of human milk samples had detectable 2′-FL at concentrations of 0.06–4.65 g 2′- FL/L. 18-10-201818-10-2018 Breakthrough of HMO, K.SaadBreakthrough of HMO, K.Saad
  18. 18.  The second study found similar results from 410 lactating women from 11 international cohorts with 65–98% of human milk samples having 2′-FL with mean concentrations ranging from 0.702–3.440 g 2′-FL/L. 18-10-201818-10-2018 Breakthrough of HMO, K.SaadBreakthrough of HMO, K.Saad
  19. 19.  The majority of HMOs contain a lactose, polylactosamine or lacto- N-biose core. Further modification by the addition of differently linked fucose or sialic acids increases their structural diversity and, in addition, provides resistance against enzymatic digestion. 18-10-201818-10-2018 Breakthrough of HMO, K.SaadBreakthrough of HMO, K.Saad
  20. 20.  Human milk oligosaccharidesHuman milk oligosaccharides (HMOs) are believed to stimulate(HMOs) are believed to stimulate the growth of bifidobacteria in thethe growth of bifidobacteria in the gastrointestinal tract (GIT) whilegastrointestinal tract (GIT) while protecting against entericprotecting against enteric pathogens.pathogens. 18-10-201818-10-2018 Breakthrough of HMO, K.SaadBreakthrough of HMO, K.Saad
  21. 21.  These OSs contain lactose at theThese OSs contain lactose at the reducing end and typically a fucosereducing end and typically a fucose or a sialic acid at the nonreducingor a sialic acid at the nonreducing end, the 2’- fucosyllactose (2’- FL)end, the 2’- fucosyllactose (2’- FL) and lacto-N-fucopentaose- I (LNF-and lacto-N-fucopentaose- I (LNF- I), both of which contain an a 1,2-I), both of which contain an a 1,2- linked fucose, being the mostlinked fucose, being the most common.common. 18-10-201818-10-2018 Breakthrough of HMO, K.SaadBreakthrough of HMO, K.Saad
  22. 22.  HMOs are believed to have manyHMOs are believed to have many roles in a developing infant, inroles in a developing infant, in addition to putative prebioticaddition to putative prebiotic functions, and may possess anti-functions, and may possess anti- adhesive effects that reduce theadhesive effects that reduce the binding of pathogenic bacteria tobinding of pathogenic bacteria to colonocytes.colonocytes. 18-10-201818-10-2018 Breakthrough of HMO, K.SaadBreakthrough of HMO, K.Saad
  23. 23.  They also have modulating effectsThey also have modulating effects on immunological processes at theon immunological processes at the level of gut-associated lymphoidlevel of gut-associated lymphoid tissue plus may also decreasetissue plus may also decrease intestinal permeability in pretermintestinal permeability in preterm infants in a dose-related manner ininfants in a dose-related manner in the first post-natal month.the first post-natal month. 18-10-201818-10-2018 Breakthrough of HMO, K.SaadBreakthrough of HMO, K.Saad
  24. 24. HMO metabolismHMO metabolism  HMOs resist digestion in the upper GIT. Evidence suggests that the majority of HMOs reach the large intestine intact. A small portion of ingested HMOs are absorbed intact into the circulation and are excreted in urine, which may explain the systemic benefits of HMOs. 18-10-201818-10-2018 Breakthrough of HMO, K.SaadBreakthrough of HMO, K.Saad
  25. 25.  For example, a key window of immune development occurs during the first few weeks of life when innate immune cells peak in the circulation. Furthermore, because ~70% of immune cells reside in the digestive tract, they may interact directly with HMOs that are consumed by infants . 18-10-201818-10-2018 Breakthrough of HMO, K.SaadBreakthrough of HMO, K.Saad
  26. 26.  HMOs have been studied from human milk for their immune benefits. In a study of 93 infant, the mother’s breast milk was analyzed for HMOs between one and five weeks postpartum and infant feeding and diarrhea data were collected for two years. 18-10-201818-10-2018 Breakthrough of HMO, K.SaadBreakthrough of HMO, K.Saad
  27. 27.  Infants whose mother’s breast milk had low concentrations of 2′-FL had significantly higher rates of Campylobacter diarrhea and calicivirus diarrhea, respectively, than infants who were fed with their mother’s breast milk with higher levels of these HMOs. 18-10-201818-10-2018 Breakthrough of HMO, K.SaadBreakthrough of HMO, K.Saad
  28. 28. HMOs in immunomodulationHMOs in immunomodulation and inflammationand inflammation 18-10-201818-10-2018 Breakthrough of HMO, K.SaadBreakthrough of HMO, K.Saad
  29. 29. Immunomodulation functions of HMOsImmunomodulation functions of HMOs  The molecules modulateThe molecules modulate immune responses indirectly,immune responses indirectly, by changing the infant gutby changing the infant gut microbiota composition, andmicrobiota composition, and directly, by affecting immunedirectly, by affecting immune cells on a systemic level, aftercells on a systemic level, after entering the bloodentering the blood circulation. The absorptioncirculation. The absorption rate of HMOs from the GIrate of HMOs from the GI tract has been reported to betract has been reported to be about 1%.about 1%. 18-10-201818-10-2018 Breakthrough of HMO, K.SaadBreakthrough of HMO, K.Saad
  30. 30. 1. Fucose-containing HMOs1. Fucose-containing HMOs (fHMOs)(fHMOs)  About 70% of human milkAbout 70% of human milk oligosaccharides areoligosaccharides are fucosylated. Fucose can befucosylated. Fucose can be attached to galactoseattached to galactose through an a1,2-linkage,through an a1,2-linkage, and to glucose or N-and to glucose or N- acetylglucosamine throughacetylglucosamine through a1,3- or a1,4-linkagea1,3- or a1,4-linkage  (Fig. 2)(Fig. 2) 18-10-201818-10-2018 Breakthrough of HMO, K.SaadBreakthrough of HMO, K.Saad
  31. 31.  The production and distribution of distinct fucosylated oligosaccharide species depends on the maternal blood group type and the stage of lactation. A 1,2-Fucosylated oligosaccharides were found to be the most abundantly represented HMOs in human milk of secretor mothers. 18-10-201818-10-2018 Breakthrough of HMO, K.SaadBreakthrough of HMO, K.Saad
  32. 32.  They are the first to appear, the longest-lasting and the most active in combating various pathogens causing diarrhea. 18-10-201818-10-2018 Breakthrough of HMO, K.SaadBreakthrough of HMO, K.Saad
  33. 33.  These oligosaccharides block the microbial and viral pathogenicity by inhibition of adhesion of Campylobacter jejuni and E. coli toxin to intestinal mucosa receptors through a competitive mechanism. 18-10-201818-10-2018 Breakthrough of HMO, K.SaadBreakthrough of HMO, K.Saad
  34. 34.  For instance, 2'-fucosyllactose lower the levels of mRNA and the membrane-bound form of CD14, which is a co-receptor for bacterial lipopolysaccharides (LPS). This led to weakening of LPS-induced inflammation during infection by different E. coli species which cause diarrhea and urologic diseases. 18-10-201818-10-2018 Breakthrough of HMO, K.SaadBreakthrough of HMO, K.Saad
  35. 35. 18-10-201818-10-2018 Breakthrough of HMO, K.SaadBreakthrough of HMO, K.Saad
  36. 36. 2. Sialo-containing HMOs (sHMOs)  The proportion of sialylated HMOs (acidic HMOs, aHMOs) in human breast milk has been reported to be about 12-30%. Sialic acid residues can be attached by a2,3- or a2,6- linkages to terminal galactose or subterminal N-acetylglucosamine (GlcNAc) (Fig. 3). 18-10-201818-10-2018 Breakthrough of HMO, K.SaadBreakthrough of HMO, K.Saad
  37. 37. 18-10-201818-10-2018 Breakthrough of HMO, K.SaadBreakthrough of HMO, K.Saad
  38. 38.  Similarly, to fucosyl oligo- saccharides, sHMOs have been demonstrated to block binding of pathogenic bacteria to intestinal epithelium. For example, an inhibitory effect by 3'-SL on Helicobacter pylori and enteropathogenic E. coli adhesion has been shown. 18-10-201818-10-2018 Breakthrough of HMO, K.SaadBreakthrough of HMO, K.Saad
  39. 39.  Also they play a positive role in the prevention of necrotizing enterocolitis (NEC) in breastfed newborns. 18-10-201818-10-2018 Breakthrough of HMO, K.SaadBreakthrough of HMO, K.Saad
  40. 40. 3. Galactosyllactoses3. Galactosyllactoses  Of special interest regarding their role in the neonate's protection are galactosyllactoses (GL), molecules with b1,3-, b1,4- and b1,6-galactosyl residues linked to the lactose core, which are typically present in human colostrum rather than mature milk (Fig. 3). 18-10-201818-10-2018 Breakthrough of HMO, K.SaadBreakthrough of HMO, K.Saad
  41. 41.  A closely related class to GL is comprised of microbiologically derived galacto-oligo-saccharides (GOS), the products of transglycosylation. 18-10-201818-10-2018 Breakthrough of HMO, K.SaadBreakthrough of HMO, K.Saad
  42. 42. 18-10-201818-10-2018 Breakthrough of HMO, K.SaadBreakthrough of HMO, K.Saad
  43. 43. Translating knowledge onTranslating knowledge on the role of HMOs into thethe role of HMOs into the treatment of diseases intreatment of diseases in infantsinfants 18-10-201818-10-2018 Breakthrough of HMO, K.SaadBreakthrough of HMO, K.Saad
  44. 44. Necrotizing enterocolitisNecrotizing enterocolitis  Necrotizing enterocolitis (NEC) is one of the main disorders of the GI tract in premature infants which is characterized by excessive inflammation and resultant necrosis of intestinal epithelium. The feasibility of HMOs application as a medication against NEC has been supported by recent studies. 18-10-201818-10-2018 Breakthrough of HMO, K.SaadBreakthrough of HMO, K.Saad
  45. 45.  HMOs exert a protective role against NEC. HMOs may become valuable supplement for the prevention and treatment of this devastating disorder in infants which do not receive human milk. 18-10-201818-10-2018 Breakthrough of HMO, K.SaadBreakthrough of HMO, K.Saad
  46. 46. Thrombo-inflammatory developmentThrombo-inflammatory development  Several studies showed an important interplay between platelets and human milk oligosaccharides. HMOs have been demonstrated to inhibit microvascular inflammation associated with the formation of platelet-neutrophil complexes. 18-10-201818-10-2018 Breakthrough of HMO, K.SaadBreakthrough of HMO, K.Saad
  47. 47.  HMOs species could be used as an infant formula supplement or potential therapeutics for the prevention and treatment of thrombo-inflammatory disorders. 18-10-201818-10-2018 Breakthrough of HMO, K.SaadBreakthrough of HMO, K.Saad
  48. 48.  An interesting study was reported on the possible role of milk oligosaccharides in treating multiple sclerosis (MS), a chronic inflammatory autoimmune disorder accompanied by demyelinisation and destruction of nervous cells. Multiple sclerosisMultiple sclerosis 18-10-201818-10-2018 Breakthrough of HMO, K.SaadBreakthrough of HMO, K.Saad
  49. 49.  Given the anti-inflammatory effects of HMOs, studies reported immune-modulatory function if HMOs by downregulating monocyte-macrophages with a subsequent reduction in deleterious cytokine production 18-10-201818-10-2018 Breakthrough of HMO, K.SaadBreakthrough of HMO, K.Saad
  50. 50. Viral and bacterial diseasesViral and bacterial diseases A protective role of HMOs against respiratory and urinary infections has been reported. In experiments with respiratory syncytial virus (RCV) and influenza virus, milk oligosaccharides were shown to be able to enhance innate antiviral response in addition to the decrease of the viral infection and/or inflammation in human airway epithelial cells. 18-10-201818-10-2018 Breakthrough of HMO, K.SaadBreakthrough of HMO, K.Saad
  51. 51.  In another study, HMOs, particularly sialo-containing fractions, have been demonstrated to protect bladder epithelial cells from detrimental cytotoxic and proinflammatory effects of urinary infection caused by uropathogenic E. coli. HMOs reduced bacterial invasion and protected host cells from bacteria-induced cell damage. 18-10-201818-10-2018 Breakthrough of HMO, K.SaadBreakthrough of HMO, K.Saad
  52. 52. 2′-fucosyllactose (2′-FL)2′-fucosyllactose (2′-FL) 18-10-201818-10-2018 Breakthrough of HMO, K.SaadBreakthrough of HMO, K.Saad
  53. 53.  Because 2′-FL is the most abundant HMO that is present in the milk of most lactating women, it has been the most studied HMO in regard to its potential systemic effects. Preclinical research shows that 2′-FL has multiple functions including: acting as a prebiotic, protecting against infections and inflammation, modulating the immune system, supporting brain development, and reducing the risk of necrotizing enterocolitis. 18-10-201818-10-2018 Breakthrough of HMO, K.SaadBreakthrough of HMO, K.Saad
  54. 54.  Synthesized 2′-FL is structurally identical to the 2′-FL in human milk. The recent availability of synthesized 2′-FL is important because HMOs were previously only found at significant levels in human milk, however they are now available in infant formulas. 18-10-201818-10-2018 Breakthrough of HMO, K.SaadBreakthrough of HMO, K.Saad
  55. 55.  Further, several 2′-FL ingredients have been the subject of Generally Recognized As Safe (GRAS) notifications and the US Food and Drug Administration has no questions on the proposed addition to infant formula. Internationally, the European Union has approved the use of 2′-FL in infant formula. Likewise, countries that refer to the European authorization will also adopt the safe addition of 2′-FL to infant formulas. 18-10-201818-10-2018 Breakthrough of HMO, K.SaadBreakthrough of HMO, K.Saad
  56. 56. Growth and Tolerance of Infants Fed Milk-Based Formula with 2′-FL  The first clinical study [Marriage, et al. J. Pediatr. Gastroenterol. Nutr. 2015, 61, 649–58] to investigate 2′-FL in infant formula was a prospective, randomized, controlled, growth, and tolerance study that was conducted in healthy term infants. 18-10-201818-10-2018 Breakthrough of HMO, K.SaadBreakthrough of HMO, K.Saad
  57. 57.  Infants were enrolled by 5 days of life (n = 420). There were four groups, including three randomized formula groups and a breastfed (BF) reference group. The three study formulas included a control formula (CF) without added HMO and two study formulas differing in the amount of 2′-FL: 0.2 g 2′- FL/L versus 1.0 g 2′-FL/L (Abbott Nutrition, Columbus, OH, USA). 18-10-201818-10-2018 Breakthrough of HMO, K.SaadBreakthrough of HMO, K.Saad
  58. 58.  The amount of 2′-FL was chosen to be within the range of 2′-FL in human milk. The primary outcome was weight gain from 14– 119 days and this was not significantly different among the formula groups or the BF reference group. Similarly, tolerance measures (including stool frequency, stool consistency, incidence of spit-up, and vomit associated with feedings) did not differ among the formula groups. 18-10-201818-10-2018 Breakthrough of HMO, K.SaadBreakthrough of HMO, K.Saad
  59. 59.  Overall, the 2′-FL containing formulas were effective at maintaining appropriate growth and tolerance and had similar 2′- FL uptake. Also, no safety concerns were observed. Marriage et al. was the first published clinical study of an infant formula with 2′-FL. 18-10-201818-10-2018 Breakthrough of HMO, K.SaadBreakthrough of HMO, K.Saad
  60. 60. Inflammatory Cytokines of Infants Fed Milk-Based Formula with 2′-FL  Goehring et al. [J. Nutr. 2016, 146,Goehring et al. [J. Nutr. 2016, 146, 2559–2566] utilized blood samples that2559–2566] utilized blood samples that were obtained from a subset of thewere obtained from a subset of the infants from the Marriage et al. studyinfants from the Marriage et al. study described before (n = 201). At six weeksdescribed before (n = 201). At six weeks of age, blood samples were drawn forof age, blood samples were drawn for markers of immune function.markers of immune function. 18-10-201818-10-2018 Breakthrough of HMO, K.SaadBreakthrough of HMO, K.Saad
  61. 61.  10 plasma inflammatory cytokines were measured and five were significantly higher in the CF group than both the BF and the 2′-FL containing formula groups: interleukin (IL)-1ra, IL-1α, IL-1β, IL-6, and tumor necrosis factor (TNF)-α. 18-10-201818-10-2018 Breakthrough of HMO, K.SaadBreakthrough of HMO, K.Saad
  62. 62.  There were no differences in the plasma concentrations of any of the 10 plasma inflammatory cytokines between the BF infants and the infants that were fed formulas with 2′-FL, demonstrating that the addition of 2′-FL resulted in lower levels of multiple cytokines, similar to the levels in the BF infants. 18-10-201818-10-2018 Breakthrough of HMO, K.SaadBreakthrough of HMO, K.Saad
  63. 63.  Overall, the circulating plasma inflammatory cytokine profiles and RSV-induced cytokine profiles of the infants that were fed either formula with 2′-FL were similar to those of the BF group. For the first time, the effect of 2′-FL on markers of immune function was investigated in formula fed infants. 18-10-201818-10-2018 Breakthrough of HMO, K.SaadBreakthrough of HMO, K.Saad
  64. 64. Gastrointestinal Tolerance of Infants Fed Milk-Based Formula with 2′-FL  A prospective, randomized, multi- center, double-blinded, controlled, tolerance trial was conducted in healthy term infants (Kajzer et al. FASEB J. 2016, 30, 671). 18-10-201818-10-2018 Breakthrough of HMO, K.SaadBreakthrough of HMO, K.Saad
  65. 65.  The study assessed GI tolerance of infants who were fed formula that was supplemented with 0.2 g 2′- FL/L and 2.0 g scFOS/L (Abbott Nutrition, Columbus, OH, USA), compared to a CF without oligosaccharides and a BF reference group. 18-10-201818-10-2018 Breakthrough of HMO, K.SaadBreakthrough of HMO, K.Saad
  66. 66.  A total of 131 infants were enrolled into the clinical trial and 119 infants completed the study duration, with 41 in the formula with 2′-FL group, 36 infants in the CF group, and 42 infants in the BF group. There were no statistically significant differences in the demographic characteristics among the three groups at enrollment. 18-10-201818-10-2018 Breakthrough of HMO, K.SaadBreakthrough of HMO, K.Saad
  67. 67.  This 2′-FL clinical study evaluated the GI tolerance of infants that were fed formulas with and without 2′-FL, compared to a BF reference group. No clinically significant differences were found among the three groups from enrollment to 35 days of age for stool consistency, formula intake, anthropometric measures, and percent feedings with spit-up/vomit associated with feeding. 18-10-201818-10-2018 Breakthrough of HMO, K.SaadBreakthrough of HMO, K.Saad
  68. 68.  Formula with 2′-FL was safe and well tolerated in infants, as evidenced by stool consistency, formula intake, percent feedings with spit-up/vomit, and reported AEs like those of the infants who were fed formula without oligosaccharides or those of the BF infants. 18-10-201818-10-2018 Breakthrough of HMO, K.SaadBreakthrough of HMO, K.Saad
  69. 69. Clinical Feeding Experience of Infants Fed a Partially Hydrolyzed Whey- Based Formula with 2′-FL  A clinical feeding experience study was recently conducted to assess the effects of switching to a partially hydrolyzed whey- based formula (PHF) supplemented with 2′-FL on symptoms of formula intolerance. 18-10-201818-10-2018 Breakthrough of HMO, K.SaadBreakthrough of HMO, K.Saad
  70. 70.  The study design was a prospective, multi-center, single- arm study investigating infants fed a PHF with 0.2 g 2′-FL/L and 1.8 g scFOS/L (Abbott Nutrition, Columbus, OH, USA). 18-10-201818-10-2018 Breakthrough of HMO, K.SaadBreakthrough of HMO, K.Saad
  71. 71.  A total of 59 infants were enrolled in the clinical feeding experience study. Forty-seven were evaluable on day 1 and 32 were evaluable at day 28. The median reduction in the severity of fussiness was statistically significant after one day (p < 0.0001). The severity of fussiness continued to decrease throughout the duration of the study. 18-10-201818-10-2018 Breakthrough of HMO, K.SaadBreakthrough of HMO, K.Saad
  72. 72.  Overall, the formula was safeOverall, the formula was safe and was well tolerated by theand was well tolerated by the infants, similar to the results thatinfants, similar to the results that were reported by Marriage et al.were reported by Marriage et al. and Kajzer et al.and Kajzer et al. 18-10-201818-10-2018 Breakthrough of HMO, K.SaadBreakthrough of HMO, K.Saad
  73. 73. Final messageFinal message  Several clinical studies reporting results of infants who were fed formula that was supplemented with 2′-FL. These clinical experiences found that the supplementation of infant formula with 2′-FL is safe and well-tolerated, and that 2′-FL is absorbed and excreted with similar efficiency compared to 2′-FL in human milk. 18-10-201818-10-2018 Breakthrough of HMO, K.SaadBreakthrough of HMO, K.Saad
  74. 74.  In addition, infants who were fed formula with 2′-FL had immune benefits like the BF reference group, had fewer parent-reported infections, specifically respiratory infections, and had improved symptoms of formula intolerance in fussy infants. 18-10-201818-10-2018 Breakthrough of HMO, K.SaadBreakthrough of HMO, K.Saad
  75. 75.  Therefore, adding 0.2 g 2′-FL/L to infant formula not only brings it closer compositionally to human milk, but also functionally. Additional clinical research may reveal other beneficial effects of 2′-FL in infant formulas, including other study populations such as preterm infants 18-10-201818-10-2018 Breakthrough of HMO, K.SaadBreakthrough of HMO, K.Saad
  76. 76. 18-10-201818-10-2018 Breakthrough of HMO, K.SaadBreakthrough of HMO, K.Saad

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