Nutritional compositions for promoting gut barrier function and ameliorating visceral pain
Inventors
Zhong, Yan • Lambers, Teartse Tim • Gross, Gabriele • Manurung, Sarmauli • van Tol, Eric A. F. • Waworuntu, Rosaline
Assignees
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Publication Number
US-9730969-B2
Publication Date
2017-08-15
Expiration Date
Abstract
The present disclosure is directed to methods for i) promoting gut regeneration, ii) promoting gut maturation and/or adaptation, iii) supporting gut barrier resistance and/or iv) protecting gut barrier function in a pediatric subject comprising administering to the pediatric subject a composition comprising an effective amount of a soluble mediator preparation derived from a late-exponential growth phase of a probiotic batch-cultivation process, such as Lactobacillus rhamnosus GG (LGG). The present methods advantageously provide the gut-protection benefits of LGG soluble mediators without introducing live bacterial culture to individuals with impaired gut barrier function. In some embodiments, the pediatric subject has impaired gut barrier function and/or short bowel syndrome. The present disclosure in other embodiments, directed methods for reducing visceral pain in a pediatric subject comprising administering to the pediatric subject a composition comprising an effective amount of a soluble mediator preparation from a late-exponential growth phase of a probiotic batch-cultivation process, such as LGG.
Core Innovation
A method is provided for promoting gut barrier regeneration, promoting gut barrier maturation and/or adaptation, supporting gut barrier resistance and/or protecting gut barrier function in a pediatric subject in need thereof. The method comprises administering a composition comprising an effective amount of a soluble mediator preparation derived from a late-exponential growth phase of a Lactobacillus rhamnosus GG (LGG) batch-cultivation process.
The soluble mediator preparation is obtained from culture supernatant harvested at the late exponential phase of the batch cultivation process and formulated into the composition after cell removal and liquid removal. The preparation optionally includes removing low molecular weight constituents from the supernatant to retain molecular weight constituents above 5 or 6 kDa, and any remaining cells are removed by 0.2 µm sterile filtration.
The document further describes administering the composition to pediatric subjects to support gut barrier function-related outcomes without administering live bacteria. The soluble mediator preparation is incorporated into nutritional compositions such as infant formula, including optional additional nutrients and formulated components, while emphasizing the use of the late-exponential phase culture supernatant as the source of the soluble mediators.
Claims Coverage
The provided partial content identifies one independent claim: a pediatric method for promoting gut barrier regeneration, maturation and/or adaptation, resistance, and/or protection using a soluble mediator preparation from late-exponential phase LGG batch-culture supernatant. The independent claim includes multiple inventive features regarding harvest timing, optional molecular weight fractionation, sterile filtration, and formulation into a composition.
Pediatric gut barrier protection by soluble mediator preparation from late-exponential phase LGG supernatant
Administering to the pediatric subject a composition comprising an effective amount of a soluble mediator preparation from a late-exponential growth phase of a Lactobacillus rhamnosus GG (LGG) batch-cultivation process to promote gut barrier regeneration, gut barrier maturation and/or adaptation, support gut barrier resistance and/or protect gut barrier function.
Late-exponential phase defined harvesting from lag-to-stationary midpoint
Producing the soluble mediator preparation by cultivating LGG in a suitable medium using a batch process and harvesting a culture supernatant at a late exponential growth phase defined with reference to the second half of the time between the lag phase and the stationary phase of the batch-cultivation process.
Optional removal of low molecular weight constituents above 5 or 6 kDa
Optionally removing low molecular weight constituents from the supernatant so as to retain molecular weight constituents above 5 or 6 kDa.
0.2 µm sterile filtration cell removal
Removing any remaining cells by 0.2 µm sterile filtration to provide the soluble mediator preparation.
Soluble mediator composition preparation with removal of liquid contents
Removing liquid contents from the soluble mediator preparation so as to obtain the composition.
Across the single independent claim, the main inventive coverage centers on using a soluble mediator preparation derived specifically from the late-exponential growth phase of LGG batch-cultivation supernatant, optionally retaining constituents above 5 or 6 kDa, removing cells via 0.2 µm sterile filtration, and formulating the resulting preparation into a composition administered to pediatric subjects for gut barrier regeneration, maturation and/or adaptation, resistance, and/or protection.
Stated Advantages
Promotes gut barrier regeneration.
Promotes gut barrier maturation and/or adaptation.
Supports gut barrier resistance and/or protects gut barrier function in a pediatric subject.
Documented Applications
Short bowel syndrome (SBS) and/or necrotizing enterocolitis (NEC) in pediatric subjects, as pediatric indication examples for administration of the soluble mediator preparation-containing composition.
Visceral pain/visceral hypersensitivity, including use in pediatric subject contexts such as colic, IBS, and diet allergy, as pediatric indication examples for administration of the soluble mediator preparation-containing composition.
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