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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic 1 | Experimental | Women receiving Lactobacillus salivarius HN6 |
|
| Probiotic 2 | Experimental | Women receiving Lactobacillus reuteri CR20 |
|
| Probiotic 3 | Experimental | Women receiving Lactobacillus fermentum LC40 |
|
| beta-lactam | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus salivarius HN6 | Biological | 9 log colony-forming units, capsules, daily, four weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Staphylococcal and/or streptococcal count in milk | 0 and 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of local and systemic symptoms associated to mastitis | days 0, 7, 14 and 28 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dpt. Nutricion, Bromatologia y Tecnologia de los Alimentos | Madrid | Madrid | 28040 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18539795 | Background | 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. | |
| 15681631 |
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| ID | Term |
|---|---|
| D008413 | Mastitis |
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D011644 | Puerperal Disorders |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D008997 | Monobactams |
| D000658 | Amoxicillin |
| D016568 | Drugs, Generic |
| D003023 | Cloxacillin |
| D019818 | Clavulanic Acid |
| ID | Term |
|---|---|
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 |
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| 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) |
|
|
| 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. |
| 14657823 | Background | 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. |
| 18045446 | Background | 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. |
| 18423017 | Background | 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. |
| 16843562 | Background | 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. |
| 16834593 | Background | 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. |
| 24880136 | Derived | 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. |
| 20455694 | Derived | 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. |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
| Sulfur Compounds |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D004364 | Pharmaceutical Preparations |
| D010068 | Oxacillin |
| D002969 | Clavulanic Acids |