Use of Probiotic Lactobacilli for the Treatment of Lactational Mastitis

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ClinicalTrials.gov Identifier: NCT00716183

Recruitment Status : Completed

First Posted : July 16, 2008

Last Update Posted : May 25, 2009

Sponsor:

Information provided by:

Universidad Complutense de Madrid

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Mastitis	Biological: Lactobacillus salivarius HN6 Biological: Lactobacillus reuteri CR20 Biological: Lactobacillus fermentum LC40 Drug: Beta-lactam antibiotic	Phase 2 Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	300 participants
Allocation:	Non-Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Phase 2/3 Evaluation of Three Lactobacilli Strains Isolated From Human Milk for the Treatment of Infectious Mastitis During the Lactation Period
Study Start Date :	July 2008
Actual Primary Completion Date :	July 2008
Actual Study Completion Date :	May 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Diseases

Drug Information available for: Lactobacillus

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Probiotic 1 Women receiving Lactobacillus salivarius HN6	Biological: Lactobacillus salivarius HN6 9 log colony-forming units, capsules, daily, four weeks
Experimental: Probiotic 2 Women receiving Lactobacillus reuteri CR20	Biological: Lactobacillus reuteri CR20 9 log colony-forming units, capsules, daily, four weeks
Experimental: Probiotic 3 Women receiving Lactobacillus fermentum LC40	Biological: Lactobacillus fermentum LC40 9 log colony-forming units, capsules, daily, four weeks
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 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 Name: Amoxicillin (generic), Cloxacillin (generic), Amoxicillin/clavulanic acid (generic), Clamoxyl, Orbenin, Augmentine

Outcome Measures

Primary Outcome Measures :

Staphylococcal and/or streptococcal count in milk [ Time Frame: 0 and 28 days ]

Secondary Outcome Measures :

Assessment of local and systemic symptoms associated to mastitis [ Time Frame: days 0, 7, 14 and 28 ]

Eligibility Criteria

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Ages Eligible for Study:	19 Years to 38 Years (Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00716183

Locations

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Spain
Dpt. Nutricion, Bromatologia y Tecnologia de los Alimentos
Madrid, Spain, 28040

Sponsors and Collaborators

Universidad Complutense de Madrid

More Information

Publications:

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.

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.

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.

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.

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.

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Vázquez-Fresno R, Llorach R, Marinic J, Tulipani S, Garcia-Aloy M, Espinosa-Martos I, Jiménez E, Rodríguez 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.

Arroyo R, Martín V, Maldonado A, Jiménez E, Fernández L, Rodríguez 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.

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Responsible Party:	Juan M. Rodríguez, Universidad Complutense de Madrid
ClinicalTrials.gov Identifier:	NCT00716183
Other Study ID Numbers:	Promast08
First Posted:	July 16, 2008 Key Record Dates
Last Update Posted:	May 25, 2009
Last Verified:	May 2009

Keywords provided by Universidad Complutense de Madrid:


mastitis Staphylococcus Streptococcus lactation breastfeeding

Additional relevant MeSH terms:

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Mastitis Puerperal Disorders Pregnancy Complications Breast Diseases Skin Diseases Anti-Bacterial Agents Amoxicillin Clavulanic Acids	Clavulanic Acid Lactams beta-Lactams Cloxacillin Anti-Infective Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action beta-Lactamase Inhibitors

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