NCT01505361

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2011

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 6, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

January 12, 2012

Status Verified

January 1, 2012

Enrollment Period

4 months

First QC Date

January 4, 2012

Last Update Submit

January 11, 2012

Conditions

Mastitis

Keywords

probioticLactobacillus salivariusmastitispreventiongroup B streptococciintrapartum prophylaxis

Outcome Measures

Primary Outcomes (1)

  • Evidence of clinical mastitis confirmed by microbiological cultures and somatic cell counts

    Weekly during the first 6 months after birth

Secondary Outcomes (1)

  • Evidence of eradication og GBS colonization as confirmed by microbiological analysis of vaginal exudate and rectal swab

    At weeks 30, 35, 40 of pregnancy

Study Arms (2)

Probiotic

EXPERIMENTAL

Pregnant women at 30 week of pregnancy(n=50) receiving Lactobacillus salivarius PS2(9 log per day, until birth)

Biological: Lactobacillus salivarius PS2

Placebo

PLACEBO COMPARATOR

Pregnant women at 30 week of pregnancy(n=50) receiving the excipient (once a day, until birth)

Biological: Excipient (milk powder)

Interventions

Lactobacillus salivarius PS2BIOLOGICAL

9 log10 (colony-forming units), freeze-dried powder, daily for 30 week of pregnancy until birth

Probiotic
Excipient (milk powder)BIOLOGICAL

100 mg/once a day from 30 week of pregnancy until birth

Placebo

Eligibility Criteria

Age25 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Public Primary Health Care Centers network

Madrid, Madrid, 28040, Spain

RECRUITING

Related Publications (4)

  • Arroyo R, Martin V, Maldonado A, Jimenez E, Fernandez L, Rodriguez JM. Treatment of infectious mastitis during lactation: antibiotics versus oral administration of Lactobacilli isolated from breast milk. Clin Infect Dis. 2010 Jun 15;50(12):1551-8. doi: 10.1086/652763.

    PMID: 20455694BACKGROUND

  • Jimenez E, Fernandez L, Maldonado A, Martin R, Olivares M, Xaus J, Rodriguez JM. Oral administration of Lactobacillus strains isolated from breast milk as an alternative for the treatment of infectious mastitis during lactation. Appl Environ Microbiol. 2008 Aug;74(15):4650-5. doi: 10.1128/AEM.02599-07. Epub 2008 Jun 6.

    PMID: 18539795BACKGROUND

  • Crepinsek MA, Taylor EA, Michener K, Stewart F. Interventions for preventing mastitis after childbirth. Cochrane Database Syst Rev. 2020 Sep 29;9(9):CD007239. doi: 10.1002/14651858.CD007239.pub4.

    PMID: 32987448DERIVED

  • Fernandez L, Cardenas N, Arroyo R, Manzano S, Jimenez E, Martin V, Rodriguez JM. Prevention of Infectious Mastitis by Oral Administration of Lactobacillus salivarius PS2 During Late Pregnancy. Clin Infect Dis. 2016 Mar 1;62(5):568-573. doi: 10.1093/cid/civ974. Epub 2015 Nov 26.

    PMID: 26611780DERIVED

MeSH Terms

Conditions

Mastitis

Interventions

Excipients

Condition Hierarchy (Ancestors)

Puerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical VehiclesPharmaceutic AidsPharmaceutical PreparationsSpecialty Uses of ChemicalsChemical Actions and Uses

Study Officials

  • Juan M Rodriguez, PhD

    Complutense University of Madrid, Spain

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Juan M Rodríguez, PhD

CONTACT

34913943837jmrodrig@vet.ucm.es

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, PhD

Study Record Dates

First Submitted

January 4, 2012

First Posted

January 6, 2012

Study Start

November 1, 2011

Primary Completion

March 1, 2012

Study Completion

June 1, 2012

Last Updated

January 12, 2012

Record last verified: 2012-01

Locations

ES(1)