Use of Probiotic Lactobacilli for the Treatment of Lactational Mastitis

Mastitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00716183
• Other study ID #: Promast08
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: July 14, 2008
• Last updated: May 22, 2009
• Start date: July 2008
• Est. completion date: May 2009

Study information

• Verified date: May 2009
• Source: Universidad Complutense de Madrid
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: May 2009
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 38 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mastitis

Intervention

Biological:
• Lactobacillus salivarius HN6
9 log colony-forming units, capsules, daily, four weeks
• Lactobacillus reuteri CR20
9 log colony-forming units, capsules, daily, four weeks
• Lactobacillus fermentum LC40
9 log colony-forming units, capsules, daily, four weeks

Drug:
• Beta-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)

Locations

Country	Name	City	State
Spain	Dpt. Nutricion, Bromatologia y Tecnologia de los Alimentos	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Complutense de Madrid

Country where clinical trial is conducted

Spain, 

References & Publications (7)

Delgado S, Arroyo R, Martín R, Rodríguez 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. — View Citation

Jiménez E, Fernández L, Maldonado A, Martín R, Olivares M, Xaus J, Rodríguez 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. — View Citation

Martín R, Heilig GH, Zoetendal EG, Smidt H, Rodríguez 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. — View Citation

Martín R, Jiménez E, Olivares M, Marín ML, Fernández L, Xaus J, Rodríguez 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. Epub 2006 Jul 14. — View Citation

Martín R, Langa S, Reviriego C, Jimínez E, Marín ML, Xaus J, Fernández L, Rodríguez JM. Human milk is a source of lactic acid bacteria for the infant gut. J Pediatr. 2003 Dec;143(6):754-8. — View Citation

Martín R, Olivares M, Marín ML, Fernández L, Xaus J, Rodríguez JM. Probiotic potential of 3 Lactobacilli strains isolated from breast milk. J Hum Lact. 2005 Feb;21(1):8-17; quiz 18-21, 41. — View Citation

Olivares M, Díaz-Ropero MP, Martín R, Rodríguez JM, Xaus J. Antimicrobial potential of four Lactobacillus strains isolated from breast milk. J Appl Microbiol. 2006 Jul;101(1):72-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Staphylococcal and/or streptococcal count in milk		0 and 28 days	No
Secondary	Assessment of local and systemic symptoms associated to mastitis		days 0, 7, 14 and 28	No