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

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ClinicalTrials.gov Identifier: NCT01505361
Recruitment Status : Unknown
Verified January 2012 by Juan M. Rodríguez, Universidad Complutense de Madrid.
Recruitment status was:  Recruiting
First Posted : January 6, 2012
Last Update Posted : January 12, 2012
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Mastitis Biological: Lactobacillus salivarius PS2 Biological: Excipient (milk powder) Phase 1 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Oral Administration of a Probiotic Strain to Pregnant Women: Effects on the Prevention of Lactational Mastitis and on the Eradication of GBS Colonization
Study Start Date : November 2011
Estimated Primary Completion Date : March 2012
Estimated Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Diseases
U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :
  1. Evidence of clinical mastitis confirmed by microbiological cultures and somatic cell counts [ Time Frame: Weekly during the first 6 months after birth ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01505361

Contact: Juan M Rodríguez, PhD 34913943837 jmrodrig@vet.ucm.es

Public Primary Health Care Centers network Recruiting
Madrid, Spain, 28040
Principal Investigator: Juan M Rodriguez, PhD         
Sub-Investigator: Leonides Fernández, PhD         
Sponsors and Collaborators
Universidad Complutense de Madrid
Principal Investigator: Juan M Rodriguez, PhD Complutense University of Madrid, Spain
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Juan M. Rodríguez, Professor, PhD, Universidad Complutense de Madrid
ClinicalTrials.gov Identifier: NCT01505361     History of Changes
Other Study ID Numbers: PROBIOPREG
First Posted: January 6, 2012    Key Record Dates
Last Update Posted: January 12, 2012
Last Verified: January 2012

Keywords provided by Juan M. Rodríguez, Universidad Complutense de Madrid:
Lactobacillus salivarius
group B streptococci
intrapartum prophylaxis

Additional relevant MeSH terms:
Puerperal Disorders
Pregnancy Complications
Breast Diseases
Skin Diseases