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US-12616664-B2 - Myo-inositol and the prevention of preterm birth

US12616664B2US 12616664 B2US12616664 B2US 12616664B2US-12616664-B2

Abstract

The present invention relates generally to the field of compositions comprising myo-inositol for use in the prevention of preterm birth and/or of conditions linked to preterm delivery in a female subject and/or in the offspring. The composition may be a nutritional composition, for example a maternal nutrition composition. The composition may be specifically designed to provide optimized nutrition to a woman desiring to get pregnant or to a pregnant woman.

Inventors

  • Chiara Nembrini
  • Irma Silva Zolezzi
  • Keith Malcolm Godfrey
  • Wayne Cutfield
  • Shiao-Yng Chan

Assignees

  • SOCIETE DES PRODUITS NESTLE S.A.

Dates

Publication Date
20260505
Application Date
20200821
Priority Date
20190826

Claims (17)

  1. 1 . A method for reducing risk of preterm birth and/or of a condition linked to preterm birth in a female subject and/or in offspring of the female subject, the method comprising administering to the female subject a composition comprising myo-inositol, wherein the female subject is at risk of preterm-onset pre-labour rupture of membranes (PPROM) and had a previous history of PPROM.
  2. 2 . The method in accordance with claim 1 , wherein the composition further comprises probiotics.
  3. 3 . The method in accordance with claim 2 , wherein the probiotics comprise a combination of Lactobacillus and Bifidobacterium.
  4. 4 . The method in accordance with claim 3 , wherein the Lactobacillus is the Lactobacillus rhamnosus GG strain available under the deposit number CGMCC 1.3724, and the Bifidobacterium is the Bifidobacterium lactis BB12 strain deposited as CNCM I-3446.
  5. 5 . The method in accordance with claim 1 , wherein the composition further comprises at least one vitamin selected from the group consisting of vitamin B2, vitamin B6, vitamin B12, vitamin D and mixtures thereof.
  6. 6 . The method in accordance with claim 1 , wherein the composition comprises the myo-inositol, vitamin B2, vitamin B6, vitamin B12, vitamin D, a Bifidobacterium lactis BB12 CNCMI-3446 and a Lactobacillus rhamnosus GG CGMCC 1.3724.
  7. 7 . The method in accordance with claim 1 , wherein the composition comprises from 0.2 to 5 g of the myo-inositol, from 0.14 to 14 mg of vitamin B2, from 0.19 to 19 mg of vitamin B6, from 0.26 to 26 μg of vitamin B12, from 1.5 to 100 μg of vitamin D, from 10 5 to 10 12 cfu of Bifidobacterium lactis BB12 CNCMI-3446 and from 10 5 to 10 12 cfu of Lactobacillus rhamnosus GG CGMCC 1.3724, all amounts being defined by daily dose.
  8. 8 . The method in accordance with claim 1 , wherein the composition further comprises zinc.
  9. 9 . The method in accordance with claim 1 , wherein the condition linked to preterm birth in the offspring of the female subject is selected from the group consisting of increased risk of neonatal respiratory conditions, necrotizing enterocolitis, sepsis, neurological conditions, feeding difficulties, visual and hearing problems, poor neurodevelopmental outcomes, high rates of hospital admissions, behavioral, social-emotional, learning difficulties in childhood, increased risks of hypertension later in life, cardiovascular and cerebrovascular diseases later in life, type 2 diabetes later in life, chronic kidney disease later in life, asthma and abnormalities in pulmonary function, neurocognitive disorder, and combinations thereof.
  10. 10 . The method in accordance with claim 1 , wherein the female subject is a mammal.
  11. 11 . The method in accordance with claim 1 , wherein the female subject is a female who is trying to get pregnant or is pregnant.
  12. 12 . The method in accordance with claim 1 , wherein the female subject is at risk of premature delivery.
  13. 13 . The method in accordance with claim 1 , wherein the composition is administered to the female subject during pregnancy.
  14. 14 . The method in accordance with claim 1 , wherein the composition is in a form selected from the group consisting of a powdered nutritional composition to be reconstituted in milk or water, a food product, a drink, a nutritional supplement, and a nutraceutical.
  15. 15 . A method for reducing risk of preterm delivery and/or conditions linked to preterm delivery in a female subject and/or in offspring of the female subject, the method comprising providing to the female subject a kit comprising at least two physically separated compositions, each comprising at least one ingredient selected from the group consisting of vitamin B2, vitamin B6, vitamin B12, and vitamin D, wherein at least one of the physically separated compositions comprises myo-inositol and at least one of the physically separated compositions comprises probiotics, wherein the female subject is at risk of preterm-onset pre-labour rupture of membranes (PPROM) and had a previous history of PPROM.
  16. 16 . The method in accordance with claim 9 , wherein the neonatal respiratory conditions comprise at least one of respiratory distress syndrome or bronchopulmonary dysplasia.
  17. 17 . The method in accordance with claim 9 , wherein the neurological conditions comprise at least one of periventricular leukomalacia, seizures, intraventricular hemorrhage, cerebral palsy, or hypoxic ischemic encephalopathy.

Description

CROSS REFERENCE TO RELATED APPLICATIONS The present application is a National Stage of International Application No. PCT/EP2020/073451, filed on Aug. 21, 2020. which claims priority to European Patent Application No. 19193541.0, filed on Aug. 26, 2019, and European Patent Application No. 20181466.2, filed on Jun. 22, 2020, the entire contents of which are being incorporated herein by reference. The present invention relates to the field of compositions comprising myo-inositol for use in the prevention of preterm birth and/or of conditions linked to preterm delivery in a female subject and/or in the offspring. The present invention also relates to the field of compositions comprising myo-inositol for use in the prevention of a preterm-onset pre-labour rupture of membranes (PPROM) and disorders and/or conditions linked thereto (including but not limited to preterm birth). The composition may be a nutritional composition, for example a maternal nutrition composition. The composition may be specifically designed to provide optimized nutrition to a woman desiring to get pregnant or to a pregnant woman. Preterm birth (PTB) is defined as birth at <37 weeks of gestation or at <259 days since the first day of a woman's last menstruation, and it is broadly classified into extremely preterm (<28 weeks), very preterm (28 to <32 weeks), moderately preterm (32 to <34 completed weeks of gestation) and late PTB (LPTB, between 34 to <37 weeks of gestation. PPROM is a pregnancy complication. In this condition, the amniotic membrane surrounding the baby ruptures prematurely. In humans, PPROM occurs before the 37th week of pregnancy. A PPROM can lead to an increased risk for infections. There is also a higher chance that the baby is born preterm before the 37th week of pregnancy. PPROM happens in about 30% of preterm births. Prognosis is primarily determined by complications related to prematurity such as necrotizing enterocolitis, intraventricular hemorrhage, and cerebral palsy, as well as intrauterine infection. Women who have had PPROM are usually at a higher risk of experiencing it again in future pregnancies. To the inventor's best knowledge, there is currently no recommended way to specifically prevent PPROM. Some have suggested that women with a history of preterm delivery, including those associated with PPROM, take progesterone supplementation to prevent a recurrence. Generally, it is recommended that women take good care of themselves during pregnancy to prevent complications. Taking good care should include ensuring an optimal nutrition. In general, scientific evidence is accumulating that prenatal early nutrition causes programming of long-term health and well-being, and can impact the risk of developing chronic diseases. Several studies have shown that changes in dietary intake or manipulation of individual macro and micronutrients during the reproductive period can have an impact in several physiological processes, such as growth, metabolism, appetite, cardiovascular function among others (Koletzko B et al (2011) Am J Nutr 94(s):2036-435). Therefore, nutritional status (nutrient stores and dietary intake) of women before and during pregnancy is of relevance to optimize neonatal and child health outcomes. Maternal nutrition is thought to affect the availability and supply of nutrients to the developing fetus that are required for critical developmental processes. Inadequate intakes of multiple micronutrients are common among women of reproductive age living in resource poor-settings (Torhem L E et al. (2010) J. Nutr. 140: 2051S-58S). A large variety of nutrients have already been used in compositions for maternal administration and various nutritional compositions have been developed to address maternal nutrition needs. These typically contain vitamin and mineral mixes. However, it would still be useful to specifically target the nutritional deficiencies of this specific population by selecting the most useful nutrients for these women such as to provide compositions tailored to the nutritional needs of women in the reproductive period to optimize the prenatal nutrition of mothers, for the benefit of the mother and of her infant. In the absence of a recommended intervention specifically to contribute to the prevention of preterm birth, in particular when this is a consequence of a preterm-onset pre-labour rupture of membranes (PPROM), it would be desirable to have such an intervention available. Further, a combination of optimal nutrition during pregnancy with a composition that is able to contribute to the prevention of preterm delivery, for example via prevention of preterm-onset pre-labour rupture of membranes (PPROM), would be desirable as well. Any reference to prior art documents in this specification is not to be considered an admission that such prior art is widely known or forms part of the common general knowledge in the field. Accordingly, there is a need to overcome one or more of the drawbacks of the