Study of a Probiotic Strain to Prevent Mastitis and to Eradicate GBS Colonization (PROBIOPREG)

January 11, 2012 updated by: Juan M. Rodríguez, Universidad Complutense de Madrid

Oral Administration of a Probiotic Strain to Pregnant Women: Effects on the Prevention of Lactational Mastitis and on the Eradication of GBS Colonization

In previous studies, the investigators have seen that carefully-selected Lactobacillus strains are a good alternative to antibiotics for the treatment of lactational mastitis. The objective of this new study is to check if they can also have a preventive role when administered to women with a history of mastitis with one or more previous infants. Since the investigators have also realized that peripartum antibiotherapy (mainly GBS-targeting intrapartum prophylaxis)is a predisposing factor for mastitis (because of the selection of resistant bacteria), the investigators would also like to test if administration of the strains to GBS-colonized pregnant women may lead to GBS eradication. Therefore, a mastitis-predisposing factor would de avoid.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

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

Study Contact

Study Locations

  • Spain
      • Madrid, Spain, 28040
        • Recruiting
        • Public Primary Health Care Centers network
        • Principal Investigator:
          • Juan M Rodriguez, PhD
        • Sub-Investigator:
          • Leonides Fernández, PhD

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

23 years to 33 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Normal pregnancy
  • Healthy women
  • Lactational mastitis in, at least, a previous lactation period
  • No symptomatic vaginal infections

Exclusion Criteria:

  • Any kind of health problems related to pregnancy
  • Symptomatic vaginal infections
  • Allergy to cow's milk protein
  • Intolerance to lactose
  • Antibiotic treatment

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Probiotic
Pregnant women at 30 week of pregnancy(n=50) receiving Lactobacillus salivarius PS2(9 log per day, until birth)
Biological: Lactobacillus salivarius PS2
9 log10 (colony-forming units), freeze-dried powder, daily for 30 week of pregnancy until birth
Placebo Comparator: Placebo
Pregnant women at 30 week of pregnancy(n=50) receiving the excipient (once a day, until birth)
Biological: Excipient (milk powder)
100 mg/once a day from 30 week of pregnancy until birth

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evidence of clinical mastitis confirmed by microbiological cultures and somatic cell counts
Time Frame: Weekly during the first 6 months after birth
Weekly during the first 6 months after birth

Secondary Outcome Measures

Outcome Measure
Time Frame
Evidence of eradication og GBS colonization as confirmed by microbiological analysis of vaginal exudate and rectal swab
Time Frame: At weeks 30, 35, 40 of pregnancy
At weeks 30, 35, 40 of pregnancy

Collaborators and Investigators

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

Sponsor

Universidad Complutense de Madrid

Investigators

  • Principal Investigator: Juan M Rodriguez, PhD, Complutense University of Madrid, Spain

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

November 1, 2011

Primary Completion (Anticipated)

March 1, 2012

Study Completion (Anticipated)

June 1, 2012

Study Registration Dates

First Submitted

January 4, 2012

First Submitted That Met QC Criteria

January 5, 2012

First Posted (Estimate)

January 6, 2012

Study Record Updates

Last Update Posted (Estimate)

January 12, 2012

Last Update Submitted That Met QC Criteria

January 11, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROBIOPREG

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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