MedTrace Logo

Effect of Probiotics Consumed During Pregnancy on the Incidence of Mastitis

NCT04032899 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 480

Last updated 2025-02-06

No results posted yet for this study

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.

Conditions

  • Mastitis
  • Breast Milk
  • Lactation
  • Women's Health
  • Infant Health

Interventions

DIETARY_SUPPLEMENT

Lactobacillus fermentum CECT5716

Each participant will consume 1 capsule per day in one of the main meals without any restriction in the diet or in their life habits.

DIETARY_SUPPLEMENT

Maltodextrin

Each participant will consume 1 capsule per day in one of the main meals without any restriction in the diet or in their life habits.

Sponsors & Collaborators

  • Biosearch S.A.

    lead INDUSTRY

Principal Investigators

  • Nicolás Mendoza, MD, PhD · Professor of Gynecology at the Faculty of Medicine of the University of Granada

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-15
Primary Completion
2024-05-31
Completion
2024-05-31

Countries

  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04032899 on ClinicalTrials.gov