Probiotics and novel probiotic delivery systems

Wala, Samantha Jane; Ragan, Mecklin V.; Sajankila, Nitin; Volpe, Samuel G.; Purayil, Nanditha; Dumbauld, Zachary; Besner, Gail E.

doi:10.1016/j.sempedsurg.2023.151307

Cited by 6 publications

(4 citation statements)

References 115 publications

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“…The estimated cost for research and development of an FDA-approved product between 2009 and 2018 was $985 million [ 45 ]. Moreover, any therapy for premature infants must be studied in a phase 1 clinical trial in adults prior to a phase 1 clinical trial in newborns, thereby significantly increasing the cost for drug development in the newborn patient population [ 6 ]. Thus, probiotic manufacturers are currently not motivated to produce a probiotic that meets the definition of a drug due to the extremely high cost and effort involved, and because their primary market is healthy outpatients rather than preterm infants.…”

Section: Discussionmentioning

confidence: 99%

“…Factors associated with prematurity, such as cesarean delivery, antibiotic exposure, parenteral nutrition, and the use of formula feeds, have been linked to dysbiosis in premature infants [ 5 ]. Breast milk has been associated with expansion of beneficial lactic acid producing bacteria, such as Lactobacillus [ 6 ]. Furthermore, neonatal dysbiosis has been associated with certain disease processes, such as necrotizing enterocolitis (NEC), late-onset sepsis, feeding intolerance, and neurodevelopmental impairment [ 7 – 10 ].…”

Section: Introductionmentioning

confidence: 99%

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Contemporary use of prophylactic probiotics in NICUs in the United States: a survey update

Wala,

Ragan,

Pryor

et al. 2024

J Perinatol

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Objective In 2015, 14.0% of US NICUs administered probiotics to very low birth weight infants. Current probiotic use prior to and after the Fall of 2023 (when FDA warnings were issued) remains unknown. Study design A survey was distributed to the American Academy of Pediatrics Section on Neonatal and Perinatal Medicine (August–November/2022) and Neonatology Solutions’ Level III/IV NICUs (January–April/2023). Probiotic administration practices were investigated. Results In total, 289 unique NICUs and 406 providers responded to the survey. Of those, 29.1% of NICUs administered prophylactic probiotics to premature neonates, however, this decreased considerably after FDA warnings were issued. Additionally, 71.4% of providers stated willingness to administer probiotics to premature infants if there was an FDA-approved formulation. Conclusions Probiotic use in US NICUs increased between 2015 and the Fall of 2023 and then dropped dramatically following warning letters from the FDA. The introduction of an FDA-approved probiotic may further expand administration.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Contemporary use of prophylactic probiotics in NICUs in the United States: a survey update

Wala,

Ragan,

Pryor

et al. 2024

J Perinatol

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“…Also another study done this year reviewed prevention and therapeutic role for the probiotics and prebiotics; the review demonstrated that planktonic probiotics may be supplied in formulations including many bacterial strains or as a single strain. Numerous randomized controlled studies have examined how single-strain planktonic probiotics affect the frequency of necrotizing enterocolitis [17]. Prebiotics are substrates that gut microorganisms use to improve the host's health.…”

Section: Prevention Strategies For Pediatric Infectious Diseasesmentioning

confidence: 99%

“…It may help regulate TLR-4 signaling in the developing gut and includes protective maternal immunoglobulin A. According to more recent studies, breast milk given to a preterm baby produces short chain fatty acids, which have an anti-inflammatory impact on immature enterocytes [17].…”

Section: Prevention Strategies For Pediatric Infectious Diseasesmentioning

confidence: 99%

New Developments in Prevention and Treatment of Pediatric Infectious Diseases

Fadl,

Mudawi,

Alqahtani

et al. 2023

JAZ

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Both adults and children are regularly afflicted by infectious illnesses. We now have a better understanding of their epidemiology, pathophysiology, prevention, and treatment because of new diagnostic techniques. Recently, emerging infections have surfaced, prompting health officials to issue warnings. Furthermore, novel anti-microbial therapies have been identified; however, because of the potential for adverse effects on antimicrobial resistance, it is critical to understand when to utilize these therapies in order to prevent overuse and misuse. In addition, new vaccinations have entered the market, and it is crucial that medical professionals understand how they may affect public health. Also the use of prebiotics and probiotics has emerged now as a preventive measure for pediatric infectious diseases.

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