Global Effects of a Probiotic Strain on Lactating Women (PROBIOLAC)

August 19, 2014 updated by: Juan M. Rodríguez, Universidad Complutense de Madrid

Oral Administration of a Probiotic to Lactating Women: Microbiological, Immunological, Transcriptomics and Metabolomics Effects

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28040
        • Dpt. Nutricion, Bromatologia y Tecnologia de los Alimentos

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Normal term pregnancy
  • Lactating women
  • Healthy breastfed infant

Women with mastitis:

  • Clinical symptoms of mastitis
  • Painful breastfeeding
  • Count of staphylococci, streptococci and/or corynebacteria in milk higher than 3,000 colony-forming units/mL
  • Leukocyte count in milk higher 6 log10/mL

Women without mastitis:

  • No clinical symptoms of mastitis
  • No painful breastfeeding
  • Count of staphylococci, streptococci and/or corynebacteria in milk lower than 500 colony-forming units/mL
  • Leukocyte count in milk lower 5 log10/mL

Exclusion Criteria:

  • Allergy to cow's milk protein
  • Intolerance to lactose
  • Antibiotic treatment
  • Breast abscess
  • Raynaud syndrome
  • Any parallel disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lactobacillus salivarius PS2
Women with mastitis (n=25) receiving Lactobacillus salivarius PS2 (9.5 log per day, 21 days)
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
Active Comparator: Lactobacillus salivarius PS2B
Lactating women without mastitis (n=15)
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evidence of Clinically Definite Mastitis Confirmed by Microbiological Cultures and Somatic Cell Counts
Time Frame: one week
Total milk bacterial count at the end of the study (after probiotic administration for 21 days), measured as log10 of the number of colony-forming units per mL of milk
one week

Secondary Outcome Measures

Outcome Measure
Time Frame
Evidence of Changes in Gene Expression of Somatic Cells Obtained From Milk Samples
Time Frame: one year
one year
Evidence of Changes in the Metabolic Profile of Urine
Time Frame: One year
One year
Evidence of Changes in the Macronutrient and Electrolyte Profiles of Milk
Time Frame: One year
One year
Evidence of Changes in the Immunological Profile of Milk
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Complutense de Madrid

Collaborators

University of Valencia
Danone Research
National Research Council, Spain

Investigators

  • Study Director: Juan M Rodríguez, PhD, Universidad Complutense de Madrid

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

May 14, 2010

First Submitted That Met QC Criteria

May 14, 2010

First Posted (Estimate)

May 17, 2010

Study Record Updates

Last Update Posted (Estimate)

August 20, 2014

Last Update Submitted That Met QC Criteria

August 19, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROBIOLAC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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