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CompletedNCT00716183Updated May 25, 2009

Use of Probiotic Lactobacilli for the Treatment of Lactational Mastitis

A Phase 2/3 interventional study of Lactobacillus salivarius HN6 and Lactobacillus reuteri CR20 in Mastitis, sponsored by Universidad Complutense de Madrid. Completed at 1 site in Spain. Open to female participants aged 19 Years to 38 Years. Per ClinicalTrials.gov, last updated 2009-05-25.

Sponsored by Universidad Complutense de Madrid · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
300
Allocation
Non-randomized
Ages
19 Years to 38 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Mastitis

Keywords

  • mastitis
  • Staphylococcus
  • Streptococcus
  • lactation
  • breastfeeding
03

In context

Mastitis

31 studies on the registry are indexed under Mastitis; 7 are open to participants now.

This study's enrollment of 300 is above the median of 114 across 16 interventional studies indexed under Mastitis.

Browse Mastitis studies →

Lead sponsor

Universidad Complutense de Madrid is the lead sponsor of 206 studies on the registry; 64 are open to participants now.

Browse Universidad Complutense de Madrid studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 38 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Mammary abscesses
  • Any kind of parallel disease
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
300 participants (actual)

Study arms

  • Experimental
    Probiotic 1

    Women receiving Lactobacillus salivarius HN6

    Biological: Lactobacillus salivarius HN6

  • Experimental
    Probiotic 2

    Women receiving Lactobacillus reuteri CR20

    Biological: Lactobacillus reuteri CR20

  • Experimental
    Probiotic 3

    Women receiving Lactobacillus fermentum LC40

    Biological: Lactobacillus fermentum LC40

  • Active comparator
    beta-lactam

    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

  • BiologicalLactobacillus salivarius HN6

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

  • BiologicalLactobacillus reuteri CR20

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

  • BiologicalLactobacillus fermentum LC40

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

  • DrugBeta-lactam antibiotic

    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

06

What researchers measure

Primary outcomes

  1. Staphylococcal and/or streptococcal count in milk

    Time frame: 0 and 28 days

Secondary outcomes

  1. Assessment of local and systemic symptoms associated to mastitis

    Time frame: days 0, 7, 14 and 28

07

Study locations

1 site
  • Dpt. Nutricion, Bromatologia y Tecnologia de los Alimentos
    Madrid, 28040, Spain
08

References and documents

Publications

  • 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. PubMed 18539795 ↗
  • 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. PubMed 15681631 ↗
  • 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. PubMed 14657823 ↗
  • 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. PubMed 18045446 ↗
  • 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. PubMed 18423017 ↗
  • 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. PubMed 16843562 ↗
  • 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. PubMed 16834593 ↗
  • 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. PubMed 24880136 ↗
  • 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. PubMed 20455694 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jul 2008, a primary completion of Jul 2008 and a completion of May 2009. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 14, 2008
First posted
Jul 16, 2008
Start
Jul 2008
Primary completionActual
Jul 2008
CompletionActual
May 2009
Last update
May 25, 2009
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 25, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00716183
Lead sponsor
Universidad Complutense de Madrid
First posted
Jul 16, 2008
Start date
Jul 2008
Primary completion
Jul 2008
Completion
May 2009
Last update
May 25, 2009

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2009. You cannot join it, but the record below documents what was studied.

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