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L.Fermentum CECT5716 in Treatment of Breast Pain

NCT02093338 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 127

Last updated 2014-03-21

No results posted yet for this study

Summary

The main objective of this intervention study is to evaluate the efficacy of Lactobacillus fermentum CECT5716 to reduce the presence in the milk of genera Staphylococcus and Streptococcus as risk factors for mastitis in women with breast pain

Conditions

  • Breast Pain

Interventions

DIETARY_SUPPLEMENT

Lactobacillus fermentum CECT5716

OTHER

Placebo Comparator: maltodextrin

Placebo

Sponsors & Collaborators

  • Junta de Andalucia

    collaborator OTHER_GOV

  • Statistical analysis: SEPLIN Soluciones Estadísticas

    collaborator UNKNOWN

  • Biosearch S.A.

    lead INDUSTRY

Principal Investigators

  • Dr. Miguel A Díaz López, Doctor · Gynecology Service of Virgen de las Nieves Hospital, Granada (Spain)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2013-04-30
Completion
2013-04-30

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 NCT02093338 on ClinicalTrials.gov