NCT00716183

Brief Summary

A total of 300 women with lactational infectious mastitis will daily ingest 9 log10 cfu of Lactobacillus salivarius HN6, Lactobacillus reuteri CR20 or Lactobacillus fermentum LC40 for 4 weeks. The three lactobacilli strains were originally isolated from milk of healthy women. On days 0 and 28, milk samples will be collected, and staphylococci/streptococci and lactobacilli will be counted and identified. Evolution of clinical signs will be recorded by midwifes on days 0, 7, 14 and 28.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

July 1, 2008

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

July 14, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 16, 2008

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

May 25, 2009

Status Verified

May 1, 2009

Enrollment Period

Same day

First QC Date

July 14, 2008

Last Update Submit

May 22, 2009

Conditions

Mastitis

Keywords

mastitisStaphylococcusStreptococcuslactationbreastfeeding

Outcome Measures

Primary Outcomes (1)

  • Staphylococcal and/or streptococcal count in milk

    0 and 28 days

Secondary Outcomes (1)

  • Assessment of local and systemic symptoms associated to mastitis

    days 0, 7, 14 and 28

Study Arms (4)

Probiotic 1

EXPERIMENTAL

Women receiving Lactobacillus salivarius HN6

Biological: Lactobacillus salivarius HN6

Probiotic 2

EXPERIMENTAL

Women receiving Lactobacillus reuteri CR20

Biological: Lactobacillus reuteri CR20

Probiotic 3

EXPERIMENTAL

Women receiving Lactobacillus fermentum LC40

Biological: Lactobacillus fermentum LC40

beta-lactam

ACTIVE COMPARATOR

The evolution of the women ascribed to the other three arms will be compared with that of 100 women suffering lactational mastitis that will follow a conventional antibiotic treatment as prescribed by the pediatrician/gynecologist

Drug: Beta-lactam antibiotic

Interventions

Lactobacillus salivarius HN6BIOLOGICAL

9 log colony-forming units, capsules, daily, four weeks

Probiotic 1
Lactobacillus reuteri CR20BIOLOGICAL

9 log colony-forming units, capsules, daily, four weeks

Probiotic 2
Lactobacillus fermentum LC40BIOLOGICAL

9 log colony-forming units, capsules, daily, four weeks

Probiotic 3
Beta-lactam antibioticDRUG

Use of amoxicillin, cloxacillin or amoxicillin/clavulanic acid(500-750 mg), orally, every 8-12 h, for 2-3 weeks (as prescribed by the physician responsible for the clinical diagnosis of lactational mastitis)

Also known as: Amoxicillin (generic), Cloxacillin (generic), Amoxicillin/clavulanic acid (generic), Clamoxyl, Orbenin, Augmentine
beta-lactam

Eligibility Criteria

Age19 Years - 38 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Clinical diagnosis of mastitis
  • Staphylococcal and/or streptococcal count higher than 3000 colony-forming units per ml of milk
  • Milk leukocyte count higher 6 log10/mL
  • Must be able to provide a milk sample without the aid of a milk pump

You may not qualify if:

  • Mammary abscesses
  • Any kind of parallel disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dpt. Nutricion, Bromatologia y Tecnologia de los Alimentos

Madrid, Madrid, 28040, Spain

Location

Related Publications (9)

  • 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

  • Martin R, Olivares M, Marin ML, Fernandez L, Xaus J, Rodriguez JM. Probiotic potential of 3 Lactobacilli strains isolated from breast milk. J Hum Lact. 2005 Feb;21(1):8-17; quiz 18-21, 41. doi: 10.1177/0890334404272393.

    PMID: 15681631BACKGROUND

  • Martin R, Langa S, Reviriego C, Jiminez E, Marin ML, Xaus J, Fernandez L, Rodriguez JM. Human milk is a source of lactic acid bacteria for the infant gut. J Pediatr. 2003 Dec;143(6):754-8. doi: 10.1016/j.jpeds.2003.09.028.

    PMID: 14657823BACKGROUND

  • Martin R, Heilig GH, Zoetendal EG, Smidt H, Rodriguez JM. Diversity of the Lactobacillus group in breast milk and vagina of healthy women and potential role in the colonization of the infant gut. J Appl Microbiol. 2007 Dec;103(6):2638-44. doi: 10.1111/j.1365-2672.2007.03497.x.

    PMID: 18045446BACKGROUND

  • Delgado S, Arroyo R, Martin R, Rodriguez JM. PCR-DGGE assessment of the bacterial diversity of breast milk in women with lactational infectious mastitis. BMC Infect Dis. 2008 Apr 18;8:51. doi: 10.1186/1471-2334-8-51.

    PMID: 18423017BACKGROUND

  • Martin R, Jimenez E, Olivares M, Marin ML, Fernandez L, Xaus J, Rodriguez JM. Lactobacillus salivarius CECT 5713, a potential probiotic strain isolated from infant feces and breast milk of a mother-child pair. Int J Food Microbiol. 2006 Oct 15;112(1):35-43. doi: 10.1016/j.ijfoodmicro.2006.06.011. Epub 2006 Jul 14.

    PMID: 16843562BACKGROUND

  • Olivares M, Diaz-Ropero MP, Martin R, Rodriguez JM, Xaus J. Antimicrobial potential of four Lactobacillus strains isolated from breast milk. J Appl Microbiol. 2006 Jul;101(1):72-9. doi: 10.1111/j.1365-2672.2006.02981.x.

    PMID: 16834593BACKGROUND

  • Vazquez-Fresno R, Llorach R, Marinic J, Tulipani S, Garcia-Aloy M, Espinosa-Martos I, Jimenez E, Rodriguez JM, Andres-Lacueva C. Urinary metabolomic fingerprinting after consumption of a probiotic strain in women with mastitis. Pharmacol Res. 2014 Sep;87:160-5. doi: 10.1016/j.phrs.2014.05.010. Epub 2014 May 29.

    PMID: 24880136DERIVED

  • 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: 20455694DERIVED

MeSH Terms

Conditions

MastitisBreast Feeding

Interventions

MonobactamsAmoxicillinDrugs, GenericCloxacillinClavulanic Acid

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

beta-LactamsLactamsAmidesOrganic ChemicalsSulfur CompoundsHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingAmpicillinPenicillin GPenicillinsPharmaceutical PreparationsOxacillinClavulanic Acids

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 14, 2008

First Posted

July 16, 2008

Study Start

July 1, 2008

Primary Completion

July 1, 2008

Study Completion

May 1, 2009

Last Updated

May 25, 2009

Record last verified: 2009-05

Locations

ES(1)