Use of Probiotic Lactobacilli for the Treatment of Lactational Mastitis
NCT ID: NCT00716183
Last Updated: 2009-05-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
300 participants
INTERVENTIONAL
2008-07-31
2009-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Probiotic 1
Women receiving Lactobacillus salivarius HN6
Lactobacillus salivarius HN6
9 log colony-forming units, capsules, daily, four weeks
Probiotic 2
Women receiving Lactobacillus reuteri CR20
Lactobacillus reuteri CR20
9 log colony-forming units, capsules, daily, four weeks
Probiotic 3
Women receiving Lactobacillus fermentum LC40
Lactobacillus fermentum LC40
9 log colony-forming units, capsules, daily, four weeks
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
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)
Interventions
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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
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Any kind of parallel disease
19 Years
38 Years
FEMALE
No
Sponsors
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Universidad Complutense de Madrid
OTHER
Responsible Party
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Universidad Complutense de Madrid
Locations
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Dpt. Nutricion, Bromatologia y Tecnologia de los Alimentos
Madrid, Madrid, Spain
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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Promast08
Identifier Type: -
Identifier Source: org_study_id
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