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Use of Probiotic Lactobacilli for the Treatment of Lactational Mastitis
This study has been completed.
Sponsor:
Universidad Complutense de Madrid
Information provided by:
Universidad Complutense de Madrid
ClinicalTrials.gov Identifier:
NCT00716183
First received: July 14, 2008
Last updated: May 22, 2009
Last verified: May 2009
| Tracking Information | |||
|---|---|---|---|
| First Received Date ICMJE | July 14, 2008 | ||
| Last Updated Date | May 22, 2009 | ||
| Start Date ICMJE | July 2008 | ||
| Primary Completion Date | July 2008 (Final data collection date for primary outcome measure) | ||
| Current Primary Outcome Measures ICMJE |
Staphylococcal and/or streptococcal count in milk [ Time Frame: 0 and 28 days ] | ||
| Original Primary Outcome Measures ICMJE | Same as current | ||
| Change History | Complete list of historical versions of study NCT00716183 on ClinicalTrials.gov Archive Site | ||
| Current Secondary Outcome Measures ICMJE |
Assessment of local and systemic symptoms associated to mastitis [ Time Frame: days 0, 7, 14 and 28 ] | ||
| Original Secondary Outcome Measures ICMJE | Same as current | ||
| Current Other Outcome Measures ICMJE | Not Provided | ||
| Original Other Outcome Measures ICMJE | Not Provided | ||
| Descriptive Information | |||
| Brief Title ICMJE | Use of Probiotic Lactobacilli for the Treatment of Lactational Mastitis | ||
| Official Title ICMJE | Phase 2/3 Evaluation of Three Lactobacilli Strains Isolated From Human Milk for the Treatment of Infectious Mastitis During the Lactation Period | ||
| 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. | ||
| Detailed Description | Not Provided | ||
| Study Type ICMJE | Interventional | ||
| Study Phase | Phase 2 Phase 3 |
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| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Mastitis | ||
| Intervention ICMJE |
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| Study Arms |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||
| Recruitment Status ICMJE | Completed | ||
| Enrollment ICMJE | 300 | ||
| Completion Date | May 2009 | ||
| Primary Completion Date | July 2008 (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 19 Years to 38 Years (Adult) | ||
| Accepts Healthy Volunteers | No | ||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
| Listed Location Countries ICMJE | Spain | ||
| Removed Location Countries | |||
| Administrative Information | |||
| NCT Number ICMJE | NCT00716183 | ||
| Other Study ID Numbers ICMJE | Promast08 | ||
| Has Data Monitoring Committee | Yes | ||
| U.S. FDA-regulated Product | Not Provided | ||
| IPD Sharing Statement | Not Provided | ||
| Responsible Party | Juan M. Rodríguez, Universidad Complutense de Madrid | ||
| Study Sponsor ICMJE | Universidad Complutense de Madrid | ||
| Collaborators ICMJE | Not Provided | ||
| Investigators ICMJE | Not Provided | ||
| PRS Account | Universidad Complutense de Madrid | ||
| Verification Date | May 2009 | ||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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