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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
Sponsor:
Information provided by (Responsible Party):
Juan M. Rodríguez, Universidad Complutense de Madrid

Tracking Information
First Submitted Date  ICMJE January 4, 2012
First Posted Date  ICMJE January 6, 2012
Last Update Posted Date January 12, 2012
Study Start Date  ICMJE November 2011
Estimated Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 5, 2012)
Evidence of clinical mastitis confirmed by microbiological cultures and somatic cell counts [ Time Frame: Weekly during the first 6 months after birth ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 5, 2012)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of a Probiotic Strain to Prevent Mastitis and to Eradicate GBS Colonization
Official Title  ICMJE Oral Administration of a Probiotic Strain to Pregnant Women: Effects on the Prevention of Lactational Mastitis and on the Eradication of GBS Colonization
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Mastitis
Intervention  ICMJE
  • Biological: Lactobacillus salivarius PS2
    9 log10 (colony-forming units), freeze-dried powder, daily for 30 week of pregnancy until birth
  • Biological: Excipient (milk powder)
    100 mg/once a day from 30 week of pregnancy until birth
Study Arms  ICMJE
  • Experimental: Probiotic
    Pregnant women at 30 week of pregnancy(n=50) receiving Lactobacillus salivarius PS2(9 log per day, until birth)
    Intervention: Biological: Lactobacillus salivarius PS2
  • Placebo Comparator: Placebo
    Pregnant women at 30 week of pregnancy(n=50) receiving the excipient (once a day, until birth)
    Intervention: Biological: Excipient (milk powder)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 5, 2012)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2012
Estimated Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 25 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01505361
Other Study ID Numbers  ICMJE PROBIOPREG
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Juan M. Rodríguez, Universidad Complutense de Madrid
Study Sponsor  ICMJE Universidad Complutense de Madrid
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Juan M Rodriguez, PhD Complutense University of Madrid, Spain
PRS Account Universidad Complutense de Madrid
Verification Date January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP