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RU-2861720-C2 - COMPOSITION FOR USE IN REDUCING NOCICEPTION IN INFANTS AND YOUNG CHILDREN

RU2861720C2RU 2861720 C2RU2861720 C2RU 2861720C2RU-2861720-C2

Abstract

FIELD: food industry. SUBSTANCE: invention relates to a nutritional composition for children aged 1 to 3 years. The nutritional composition in the form of an infant formula for children aged 1 to 3 years comprises 6’-sialyllactose (6’SL) and lacto-N-tetraose (LNT) and is used to reduce nociception in a child. EFFECT: reduction of pain perception in children aged 1 to 3 years. 13 cl, 6 dwg, 1 tbl, 4 ex

Inventors

  • DAMAK, SAMI
  • SPRENGER, NORBERT
  • FOATA, Francis

Dates

Publication Date
20260508
Application Date
20221011
Priority Date
20171222

Claims (20)

  1. 1. The use of a nutritional composition in the form of a milk formula for children from 1 to 3 years old, containing 6’-sialyllactose (6’SL) and lacto-N-tetraose (LNT), to reduce nociception in a child.
  2. 2. Use according to paragraph 1, wherein said use is intended to reduce abdominal pain in a child.
  3. 3. The use according to paragraph 1 or 2, wherein said use is intended to reduce pain associated with gastrointestinal discomfort and/or gastrointestinal disorder.
  4. 4. The use according to claim 3, wherein the gastrointestinal discomfort is caused by colic, bloating, and/or spasms, and/or wherein the gastrointestinal disorder is selected from inflammatory bowel disease (IBD), diarrhea such as infectious diarrhea, necrotizing enterocolitis (NEC) and functional abdominal pain disorders, preferably selected from irritable bowel syndrome (IBS), abdominal migraine and functional abdominal pain not otherwise specified (FAB-NOS).
  5. 5. The use according to any of the preceding claims, wherein the 6'SL and LNT are present in a weight ratio of 6'SL:LNT from 3:1 to 1:3, such as from 2:1 to 1:2 or from 2:1 to 1:1.
  6. 6. Application under any of the preceding paragraphs, wherein
  7. a. 6'SL is present in an amount of 0.005-5 g/L of the composition or in an amount of 0.004-3.8 g/100 g of the composition based on dry matter weight; and/or
  8. b. LNT is present in an amount of 0.005-3 g/l of the composition or in an amount of 0.004-2.3 g/100 g of the composition based on the dry matter weight.
  9. 7. Application under any of the preceding paragraphs, wherein
  10. a. 6'SL is present in an amount of 0.008-2.5 g/L of the composition or in an amount of 0.006-1.9 g/100 g of the composition based on dry matter weight; and/or
  11. b. LNT is present in an amount of 0.01-1.5 g/l of the composition or in an amount of 0.008-1.2 g/100 g of the composition based on the dry matter weight.
  12. 8. Application under any of the preceding paragraphs, wherein
  13. a. 6'SL is present in an amount of 0.01-1 g/l of the composition or in an amount of 0.008-0.8 g/100 g of the composition based on dry matter weight; and/or
  14. b. LNT is present in an amount of 0.04-1.2 g/l of the composition or in an amount of 0.03-0.9 g/100 g of the composition based on the dry matter weight.
  15. 9. Application under any of the preceding paragraphs, wherein
  16. a. 6'SL is present in an amount of 0.03-0.7 g/L of the composition or in a total amount of 0.023-0.5 g/100 g of the composition based on dry matter weight; and/or
  17. b. LNT is present in an amount of 0.05-1 g/l of the composition or in an amount of 0.04-0.8 g/100 g of the composition based on the dry matter weight.
  18. 10. Application under any of the preceding paragraphs, wherein
  19. a. 6'SL is present in an amount of 0.04-0.5 g/L of the composition or in an amount of 0.031-0.4 g/100 g of the composition based on dry matter weight; and/or
  20. b. LNT is present in an amount of 0.09-0.8 g/l of the composition or in an amount of 0.07-0.6 g/100 g of the composition based on the dry matter weight.

Description

Field of application of the invention The present invention relates to compositions containing 6'-sialyllactose (6'SL) and lacto-N-tetraose (LNT) for use in reducing nociception in an infant or young child. The compositions are particularly useful for reducing abdominal pain, such as pain associated with intestinal discomfort and/or intestinal disorders, and therefore also help to reduce crying periods and improve sleep quality and overall quality of life in infants and young children. Prerequisites for the creation of the invention Infants, including newborns, experience pain similarly to adults, as shown, for example, in the work of Goksan et al.; fMRI reveals neural activity overlap between adult and infant pain; eLife 2015;4:e06356. Other studies even suggest that infants may perceive pain more acutely than adults and older children. Infants and young children can experience a variety of types of pain, ranging from acute pain to habitual pain, which may, for example, be caused by inflammation that can become chronic. In infants and young children, as in adults, pain is associated with responses such as increased heart rate, faster and shallower breathing movements leading to decreased oxygen saturation, and increased blood pressure. Such responses, induced by prolonged or repeated exposure to pain, have been found to have a negative impact on the development of infants and young children and can lead, for example, to abnormalities in the development of the pain system, such as hyperalgesia, or to dysregulation of stress-related hormones, such as increased cortisol production. See, for example, Ziraldo, Breanne, Infant Pain Management (2010); Senior Honors Theses; 198, which is available from Liberty University, Virginia, USA, and is available on the date of application at http://digitalcommons.liberty.edu/honors/198. Infants and young children are particularly susceptible to certain sources of pain, such as abdominal pain. Causes of abdominal pain include abdominal discomfort and abdominal disorders. One example of a common cause of discomfort is colic. The cause of colic is not fully understood, but it appears to be related to the intestine's hypersensitivity to pain. Therefore, intestinal distension caused by the normal passage of gas or stool leads to pain in colicky infants, triggering prolonged periods of crying, poor sleep, and a reduced quality of life for both the infant and parents. Abdominal pain can also result from other causes of discomfort, such as changes in bowel habits, exposure to new foods, bloating, and cramping. Disorders such as inflammatory bowel disease (IBD), diarrhea (such as infectious diarrhea), necrotizing enterocolitis (NEC), and functional abdominal pain disorders also occur. Inflammatory bowel disease (IBD) is a serious, chronic, and destructive disorder of the gastrointestinal tract. It includes Crohn's disease (CD) and ulcerative colitis (UC). Functional abdominal pain disorders and non-destructive gastrointestinal disorders include irritable bowel syndrome (IBS), abdominal migraine, and functional abdominal pain not otherwise specified (FAB-NOS). An additional, detailed definition of functional abdominal pain disorders is provided by Hyams et al.; Childhood Functional Gastrointestinal Disorders: Child/Adolescent; Gastroenterology 150 (2016):1456–1468. Thus, reducing nociception is desirable for infants and young children. However, the side effects associated with pain medications can be even more problematic in infants and young children than in adults. Therefore, identifying non-pharmacological agents for reducing nociception in infants and young children that pose a low risk to the infant or young child is of particular interest. Identifying ingredients specifically formulated for human infants and/or young children that can reduce nociception would be particularly advantageous. Breast milk is recommended for all infants. However, in some cases, breastfeeding is insufficient or ineffective for medical reasons, or the mother chooses not to breastfeed. Infant formulas have been developed for these situations. Fortifiers have also been developed to fortify breast milk or infant formula with certain ingredients. In such cases, it would be even more beneficial to provide means to reduce nociception and thereby reduce the incidence of pain in infants and young children through nutritional interventions. The prior art has already investigated the effects of dietary ingredients such as human breast milk oligosaccharides on pain. US2016/0243139 discloses the use of synthetic compositions containing one or more human milk mono- or oligosaccharides for the treatment of visceral pain. According to the teachings of this document, a wide variety of human milk mono- and oligosaccharides can be used, with 2'-FL, 3'FL, DFL, LNnT, 3'-SL, 6'-SL, or LNFP-1 being preferred, and a mixture of 2'-FL and LNnT or LNT being most preferred. WO2016/139329 relates to compositions for use in impro