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OpenTrials
Completed

NCT Number: NCT00716183

Use of Probiotic Lactobacilli for the Treatment of Lactational Mastitis

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.

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Key information

Conditions

Mastitis Behavior Breast Diseases Breast Feeding Feeding Behavior Female Urogenital Diseases and Pregnancy Complications Pregnancy Complications Puerperal Disorders Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases

Age range

19 year–38 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Dpt. Nutricion, Bromatologia y Tecnologia de los Alimentos

Madrid, 28040, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • Mammary abscesses
  • Any kind of parallel disease

Treatment and study plan

Lactobacillus salivarius HN6

Biological

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

Lactobacillus reuteri CR20

Biological

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

Lactobacillus fermentum LC40

Biological

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

Beta-lactam antibiotic

Drug

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)

Other names: Amoxicillin (generic), Cloxacillin (generic), Amoxicillin/clavulanic acid (generic), Clamoxyl, Orbenin, Augmentine

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

Sponsors and collaborators

Lead sponsor

Universidad Complutense de Madrid

Other

Registry information

Official study title

Phase 2/3 Evaluation of Three Lactobacilli Strains Isolated From Human Milk for the Treatment of Infectious Mastitis During the Lactation Period

Important dates

Study start
2008
Primary completion
2008
Study completion
2009
First posted
Jul 16, 2008
Registry last updated
May 25, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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