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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2012 by Juan M. Rodríguez, Universidad Complutense de Madrid.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01505361
First Posted: January 6, 2012
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Juan M. Rodríguez, Universidad Complutense de Madrid
  Purpose
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 Intervention Phase
Mastitis Biological: Lactobacillus salivarius PS2 Biological: Excipient (milk powder) Phase 1 Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Juan M. Rodríguez, Universidad Complutense de Madrid:

Primary Outcome Measures:
  • 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:
  • 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 ]

Estimated Enrollment: 100
Study Start Date: November 2011
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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
Criteria

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


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

Locations
Spain
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
Investigators
Principal Investigator: Juan M Rodriguez, PhD Complutense University of Madrid, Spain
  More Information

Additional Information:
Publications:
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 Submitted: January 4, 2012
First Posted: January 6, 2012
Last Update Posted: October 12, 2017
Last Verified: January 2012

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

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