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EP-4740751-A1 - INFANT OR YOUNG CHILD FORMULA

EP4740751A1EP 4740751 A1EP4740751 A1EP 4740751A1EP-4740751-A1

Abstract

The present invention relates to nutritional compositions for infants and young children comprising the human milk oligosaccharides (HMOs) 2'-fucosyllactose (2FL) and lacto-N- neotetraose (LNnT), for modulating maturation of the gut microbiome. The formula may be an extensively hydrolysed formula (eHFs) or an amino acid-based infant formula (AAFs) and may be used in an infant with cow's milk protein allergy.

Inventors

  • HEINE, Ralf, Günter

Assignees

  • Société des Produits Nestlé S.A.

Dates

Publication Date
20260513
Application Date
20211007

Claims (13)

  1. An infant or young-child formula comprising the human milk oligosaccharides (HMOs) 2'-fucosyllactose (2'FL) and lacto-N-neotetraose (LNnT) for use (i) in inhibiting or reducing premature maturation of the gut microbiota, and/or (ii) delaying maturation of the gut microbiota in an infant or young child, and/or (iii) inducing a microbiota that is less diverse at 12 months age compared the microbiota at 12 months age of an infant receiving a conventional infant formula not comprising 2'FL and LNnT, and/or (iv) inducing a lower gut microbiota age at 12 months age, compared to an infant receiving a conventional infant formula not comprising 2'FL and LNnT.
  2. An infant or young-child formula for use according to claim 1, wherein a lower microbiota age at 12 months age means having a gut microbiome enriched in early-type faecal community type (FCT) clusters, compared to an infant receiving an infant formula not comprising said 2'FL and LNnT .
  3. An infant or young-child formula for use according to claim 1, wherein a lower microbiota age at 12 months age means having a gut microbiome diminished in late-type faecal community type (FCT) clusters compared to an infant receiving an infant formula not comprising said 2'FL and LNnT .
  4. An infant formula for use according to any one of claims 1 to 3, wherein the infant formula comprises 0.5-3 g/L, 0.8-1.5 g/L, or about 1 g/L 2'FL, preferably wherein the infant formula comprises about 1 g/L 2'FL.
  5. An infant formula for use according to any one of claims 1 to 4, wherein the infant formula comprises 0.2-1 g/L, 0.5-0.8 g/L, or about 0.5 g/L LNnT, preferably wherein the infant formula comprises about 0.5 g/L LNnT.
  6. An infant formula for use according to any one of claims 1 to 5, wherein the infant formula comprises about 1 g/L 2'FL and about 0.5 g/L LNnT.
  7. An infant formula for use according to any one of claims 1 to 6, wherein the infant formula is an eHF and wherein the infant formula comprises 1.8-2.4 g protein per 100 kcal, preferably between 2.0 and 2.4g protein per 100kcal, preferably 2.1-2.3 g protein per 100 kcal, or 2.15-2.25 g protein per 100 kcal.
  8. An infant formula for use according to any one of claims 1 to 6, wherein the infant formula is an AAF, and wherein the infant formula comprises 1.8-2.9g protein per 100kcal, preferably 1.9-2.8g protein per 100 kcal, preferably 2.0-2.7 g protein per 100kcal, more preferably 2.0-2.6 g protein per 100 kcal, or 2.0-2.4 g per 100kcal.
  9. An infant formula for use according to any one of claims 1 to 8, wherein the infant formula comprises about 2.2 g protein per 100 kcal.
  10. An infant formula for use according to any one of claims 1 to 9, wherein about 25% or less by weight, 20% or less by weight, 15% or less by weight, 10% or less by weight, 5% or less by weight, or 1% or less by weight of the fat in the infant formula is medium chain triglycerides (MCTs).
  11. An infant formula for use according to any one of claims 1 to 10, wherein the infant formula comprises no added MCTs.
  12. An infant formula for use according to any one of claims 1 to 11, wherein the infant formula comprises 9-14 g carbohydrate per 100 kcal and/or 4.0-6.0 g fat per 100 kcal.
  13. An infant formula for use according to any one of claims 1to 12, wherein the infant has cow's milk protein allergy.

Description

FIELD OF THE INVENTION The present invention relates to nutritional compositions for infants and young children and their health effects in infants. In particular, it relates to infant or young child formula comprising the human milk oligosaccharides (HMOs) 2'-fucosyllactose (2FL) and lacto-N-neotetraose (LNnT), for modulating maturation of the gut microbiome. The formula may be an extensively hydrolysed formula (eHFs) or an amino acid-based infant formula (AAFs) and may be used in an infant with cow's milk protein allergy. BACKGROUND TO THE INVENTION Cow's milk protein (CMP) is the leading cause of food allergy in infants, affecting 2-3% children worldwide. Most children with CMP-allergy (CMPA) have two or more symptoms: 50-70% have skin symptoms; 50-60% have gastrointestinal symptoms; and 20-30% have airway symptoms. Severe and life-threatening symptoms may occur in 10% of children. (Nutten, 2018. EMJ Allergy Immunol, 3(1), pp. 50-59). Human breast milk and breast feeding are considered to be the optimal form of nutrition for healthy infants during the first months of life. Breast milk remains the gold standard for feeding infants with CMPA. The European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) recommends that CMPA is best treated in breast-fed infants by complete elimination of cow's milk from the mother's diet (Koletzko, S., et al., 2012. Journal of Pediatric Gastroenterology and Nutrition, 55(2), pp.221-229). Specialty infant formulas are recommended when breastfeeding is not possible. ESPGHAN recommends that for non-breast-fed infants with CMPA, formulas based on extensively hydrolysed proteins (eHF) are used, with proven efficacy in infants with CMPA. In infants with severe or life-threatening symptoms, an amino acid-based infant formula (AAF) may be considered as the first choice (Koletzko, S., et al., 2012. Journal of Pediatric Gastroenterology and Nutrition, 55(2), pp.221-229). There is growing evidence regarding the role of infant gut microbial composition in the immune trajectory and allergy development of the infant host (Quante M. et al. (2012) BMC Public Health 12: 1021). As such, environmental factors such as diet, pollution, urban lifestyle, cleanliness and birth method have been associated with the development of the immune system and allergic diseases (Seppo, A.E. et al. (2017) J Allergy Clin Immunol 139: 708-11 e5; Azad, M.B. et al. (2018) J Nutr 148: 1733-42). Infancy, especially the first weeks, 3 months, 6 months or 12 months of life is a critical period for the establishment of a balanced gut microbiota. It is known that the modulation of the gut microbiota during infancy can prospectively have a significant influence in the future health status of the body. For example, the gut microbiome can influence the development of a strong immune system later in life, as well as normal growth, and even on the development of obesity later in life. The gut microbiome and its evolution during the development of the infant is, however, a fine balance between the presence and prevalence (amount) of many populations of gut bacteria. Some gut bacteria are classified as "generally positive" while others are "generally negative" (or pathogenic) regarding their effect on the overall health of the infant. Certain species of "generally positive" bacteria, such as bifidobacteria, may be under-represented in infants fed conventional infant formula in comparison to breastfed infants. Similarly, some bacterial populations are considered pathogenic and should remain at a low prevalence in the gut microbiota. Infants fed infant formulae may not benefit from the healthy, well balanced intestinal gut microbiome seen in infants fed exclusively, or predominantly, human breast milk. The development of a healthy microbiome in the first years of life is complex and prone to disturbances by environmental factors. Many taxa of micro-organisms co-exist in the highly complex microenvironment of the gut/intestine, each in sequentially defined proportions. Quantitative and qualitative dimensions are to be considered when defining the microbiota of infants or young children. Furthermore, the variation over time of the gut microbiota adds to the complexity. The fine balance of all the families, genera, species and strains of bacteria present in each location of the gastrointestinal tract, as well as their variation over time, all contribute to the "gastro-intestinal health" of infants and young children. Recent studies have observed a consistent increase in microbiota age for breast-fed infants compared to formula-fed infants, receiving little or no breast milk. These early changes in gut microbiota associated with formula-fed infants have been inversely linked to immunological and biological maturity of infants in early months of life (Stewart CJ et al., Nature 2018;562:583-8; Ho NT et al., Nature Communications 2018;9:4169). A suitable and healthy gut microbiota is a key factor in the dev