drugset / Trial / NCT00716183
Use of Probiotic Lactobacilli for the Treatment of Lactational Mastitis
Non-randomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2008-07
- Primary completion
- 2008-07
- Completion
- 2009-05
Publications
- 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.
- Background 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Amoxicillin | Other / unclassified | 500 mg | Oral |
| Comparator | Amoxicillin | Other / unclassified | 750 mg | Oral |
| Subject | Lactobacillus fermentum LC40 | Other / unclassified | 9 unknown | Oral |
| Subject | Lactobacillus reuteri CR20 | Other / unclassified | 9 unknown | Oral |
| Subject | Lactobacillus salivarius HN6 | Other / unclassified | 9 unknown | Oral |
| Comparator | amoxicillin/clavulanic acid | Other / unclassified | 500 mg | Oral |
| Comparator | amoxicillin/clavulanic acid | Other / unclassified | 750 mg | Oral |
| Comparator | cloxacillin | Other / unclassified | 500 mg | Oral |
| Comparator | cloxacillin | Other / unclassified | 750 mg | Oral |