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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Universidad Complutense de Madrid.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Juan M. Rodríguez, Universidad Complutense de Madrid
ClinicalTrials.gov Identifier:
NCT01505361
First received: January 4, 2012
Last updated: January 11, 2012
Last verified: January 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   25 Years to 35 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
Responsible Party: Juan M. Rodríguez, Professor, PhD, Universidad Complutense de Madrid
ClinicalTrials.gov Identifier: NCT01505361     History of Changes
Other Study ID Numbers: PROBIOPREG
Study First Received: January 4, 2012
Last Updated: January 11, 2012
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by 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

ClinicalTrials.gov processed this record on October 19, 2014