CompletedNot Applicable

Effect of Probiotics Consumed During Pregnancy on the Incidence of Mastitis

Spain480 participantsStarted 2019-04-15

Plain-language summary

The aim of the present study is to evaluate the effect of consumption during pregnancy and the lactation period of the probiotic L. fermentum CECT5716 on the incidence of mastitis. Bacterial load and immunological parameters in breast milk, parameters related to breastfeeding as well as health parameters of the mother and baby will also be evaluated.

Who can participate

Age range18 Years – 45 Years

SexFEMALE

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Inclusion Criteria: * Normal development of pregnancy * Single fetus pregnancy * Be in week 28-32 of pregnancy * Intention to breastfeed the child for 16 weeks Exclusion Criteria: * Having a breast disease that hinders or prevents breastfeeding * Have been taking probiotic supplements 2 weeks before starting the study * Have a low expectation of adherence to the study protocol

What they're measuring

Incidence of mastitis

Timeframe: 4 months

Trial details

NCT IDNCT04032899

SponsorBiosearch S.A.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-05-31

View on ClinicalTrials.gov More Mastitis trials