grant

Antibiotic Treatment in Breastfeeding Mothers: Effects on Milk, Microbiome, and Infant Outcomes

Organization UNIVERSITY OF CALIFORNIA, SAN DIEGOLocation LA JOLLA, UNITED STATESPosted 10 Sept 2021Deadline 31 Jul 2026
NIHUS FederalResearch GrantFY20251 year of age1 year old21+ years oldActive Follow-upAdultAdult HumanAgeAmox-clavAmoxi-ClavulanateAmoxicillinAmoxicillin-Clavulanate PotassiumAmoxicillin-Clavulanic AcidAmoxicillin-Potassium Clavulanate CombinationAmoxicillineAmoxilAmoxycillinAmoxycillin-Clavulanic AcidAnalytic ChemistryAnalytical ChemistryAntibiotic AgentsAntibiotic DrugsAntibiotic TherapyAntibiotic TreatmentAntibioticsAssayAugmentinAzadoseAzithromycinAzitrocinAzythromycinBioassayBiological AssayBiological MarkersBreast FeedingBreast MilkBreast fedBreast fed infantBreastfedBreastfed infantBreastfeedingBreastmilkCaliforniaCarbohydratesClavulanate Potentiated AmoxycillinClavulanic AcidsClinicalCo-amoxiclavCoamoxiclavCollaborationsCollectionDataData ScienceDevelopmentDrug KineticsDrug PrescribingDrug PrescriptionsEnrollmentFatsFatty acid glycerol estersFecesFemaleGeneralized GrowthGrowthGrowth and DevelopmentGrowth and Development functionHealth Care ProvidersHealth PersonnelHeightHomeHome environmentHuman MilkHuman Mother's MilkHydroxyampicillinImmune responseInfantInfant DevelopmentInfectionInfrastructureInterdisciplinary ResearchInterdisciplinary StudyInterviewKnowledgeLactationLifeMacrobidMacrodantinMammary Gland MilkMeasuresMedical RecordsMilkMiscellaneous AntibioticMonitorMother's MilkMothersMultidisciplinary CollaborationMultidisciplinary ResearchNitrofurantoinNutritionalOligosaccharidesParticipantPharmacokineticsPolymoxPopulationPost-partum WomenPostpartum PeriodPostpartum WomenProteinsPublic HealthQualifyingQuestionnairesResearchSamplingSkinSwabTestingTimeTissue GrowthTransmissionTrimoxUltreonUniversitiesUpper Respiratory InfectionsUpper Respiratory Tract InfectionUrinary tractUtimoxWeightWomanWritingWymoxZithromaxZitromaxactive followupadulthoodage 1 yearaged 1 yearaged one yearagesbacterial disease treatmentbacterial infectious disease treatmentbio-markersbiobankbiologic markerbiomarkerbiorepositorybreast feeding infantbreastfeeding infantdevelopmentalenrollevidence basefecal samplefollow upfollow-upfollowed upfollowupgut healthgut microbiome of infanthealth care personnelhealth care workerhealth providerhealth workforcehomeshost responseimmune system responseimmunoresponseinfant gut microbiomeinfant outcomelactatinglactationalmalemastitismaternal milkmedical personnelmedication prescriptionmetabolism measurementmetabolomicsmetabonomicsmicrobial consortiamicrobial floramicrobiomemicrobiotamicrofloramultispecies consortianeonate gut microbiomenewborn gut microbiomenutritiousone year of ageone year oldontogenypharmacometricspost-partumprescribed medicationprospectiverecruitreproductivestoolstool samplestool specimentransmission processtreatment provideruptakeweights
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Full Description

PROJECT SUMMARY
Antibiotic use is common among women of reproductive potential, including lactating women. However, little is

known about the transmission and pharmacokinetics of specific antibiotics in human milk, nor the effects of

antibiotic treatment on milk composition and quality including nutritional components, oligosaccharide profile,

and the microbiome. Establishment of the infant gut microbiome is dependent on a dynamic maternal–infant

microbiota exchange during early life, which is largely facilitated via breastfeeding. It is thus critical to better

understand the impact of specific antibiotics on milk composition. Furthermore, it is essential to determine how

maternal antibiotic use may impact infant outcomes, including growth, development, and immune response.

Building on the infrastructure of the University of California San Diego Human Milk Research Biorepository, a

highly qualified, multidisciplinary research team will prospectively enroll and interview 480 maternal/infant pairs

at baseline, collect milk, skin, and stool samples, and monitor ongoing breastfeeding practices and maternal use

of one of four commonly used antibiotics over time. From these, we will subsequently identify 40 maternal/infant

pairs with maternal uptake of target antibiotic treatment, 40 matched maternal/infant pairs without antibiotic

exposure, and 20 non-lactating maternal/infant pairs with maternal uptake of a target antibiotic treatment. From

these 100 pairs, we will collect additional home and maternal and infant biomarkers of exposure at 3 timepoints

corresponding to antibiotic initiation, mid-course, and end-course, collect interview and medical record data, and

obtain a questionnaire assessment of infant development at 12 months post-partum. Data will be used to

determine the amount and pharmacokinetics of target antibiotics in breast milk samples and to test the central

hypotheses that (1) milk composition, oligosaccharide, and microbiome profiles will differ between groups by

antibiotic treatment status; (2) microbiome and metabolomic measures will differ in treated and untreated

breastfeeding groups; and (3) antibiotics will be detectable in the stool, skin, and home environment swabs of

mothers who are treated with antibiotics but are not breastfeeding. We will also explore the impact on maternal

antibiotic use on infant growth and development.

Findings of this study will fill a critical gap in knowledge regarding the presence of commonly used antibiotics

in breast milk and the effects of antibiotic treatment on both breast milk composition and quality as well as short-

and long-term infant outcomes, including growth, development, gut health, and immune response. This will

inform evidence-based development of specific guidance on antibiotic use during lactation and help support

advice provided by healthcare providers to breastfeeding women.

Grant Number: 5P50HD106463-05
NIH Institute/Center: NIH

Principal Investigator: CHRISTINA CHAMBERS

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