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Global Effects of a Probiotic Strain on Lactating Women

NCT01124448 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2014-08-20

Study results available
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Summary

In this study, the investigators will try to confirm if application of probiotic strains isolated from breast milk actually have a beneficial effect on women suffering lactational mastitis. This project has been design to offer an integrated vision of the effects of probiotherapy (Lactobacillus salivarius PS2) on the human host. Therefore, the investigators propose a multidisciplinary approach involving the application of microbiological, immunological, genomic, metagenomic, transcriptomic and metabolomic techniques. The hypothesis is that probiotherapy will cause different effects on the host, and the objective is the finding of markers that may support the beneficial effect of the strain in such condition.

Conditions

  • Mastitis

Interventions

BIOLOGICAL

Lactobacillus salivarius PS2

9.5 log10 (colony-forming units), freeze-dried powder, daily for 21 days

BIOLOGICAL

Lactobacillus salivarius PS2

9.5 log10 colony-forming units, oral route, freeze-dried powder, daily for 21 days

Sponsors & Collaborators

  • National Research Council, Spain

    collaborator OTHER_GOV

  • University of Valencia

    collaborator OTHER

  • Danone Global Research & Innovation Center

    collaborator INDUSTRY

  • Universidad Complutense de Madrid

    lead OTHER

Principal Investigators

  • Juan M Rodríguez, PhD · Universidad Complutense de Madrid

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2013-09-30
Completion
2013-12-31

Countries

  • Spain

Study Locations

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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 NCT01124448 on ClinicalTrials.gov