An interventional study of Lactobacillus salivarius PS2 and Lactobacillus salivarius PS2 in Mastitis, sponsored by Universidad Complutense de Madrid. Completed at 1 site in Spain. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-08-20.
Sponsored by Universidad Complutense de Madrid · Not applicable, Interventional, and Basic science
In this study, the investigators will try to confirm if application of probiotic strains isolated from breast milk actually have a beneficial effect on women suffering lactational mastitis. This project has been design to offer an integrated vision of the effects of probiotherapy (Lactobacillus salivarius PS2) on the human host. Therefore, the investigators propose a multidisciplinary approach involving the application of microbiological, immunological, genomic, metagenomic, transcriptomic and metabolomic techniques. The hypothesis is that probiotherapy will cause different effects on the host, and the objective is the finding of markers that may support the beneficial effect of the strain in such condition.
31 studies on the registry are indexed under Mastitis; 7 are open to participants now.
This study's enrollment of 40 is below the median of 114 across 16 interventional studies indexed under Mastitis.
Browse Mastitis studies →Universidad Complutense de Madrid is the lead sponsor of 206 studies on the registry; 64 are open to participants now.
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Women with mastitis:
Women without mastitis:
Exclusion Criteria:
Women with mastitis (n=25) receiving Lactobacillus salivarius PS2 (9.5 log per day, 21 days)
Biological: Lactobacillus salivarius PS2
Lactating women without mastitis (n=15)
Biological: Lactobacillus salivarius PS2
9.5 log10 (colony-forming units), freeze-dried powder, daily for 21 days
9.5 log10 colony-forming units, oral route, freeze-dried powder, daily for 21 days
Evidence of Clinically Definite Mastitis Confirmed by Microbiological Cultures and Somatic Cell Counts
Total milk bacterial count at the end of the study (after probiotic administration for 21 days), measured as log10 of the number of colony-forming units per mL of milk
Time frame: one week
Evidence of Changes in Gene Expression of Somatic Cells Obtained From Milk Samples
Time frame: one year
Evidence of Changes in the Metabolic Profile of Urine
Time frame: One year
Evidence of Changes in the Macronutrient and Electrolyte Profiles of Milk
Time frame: One year
Evidence of Changes in the Immunological Profile of Milk
Time frame: one year
| Milestone | Lactobacillus Salivarius PS2 | Lactobacillus Salivarius PS2B |
|---|---|---|
| Started | 25 | 15 |
| Completed | 23 | 12 |
| Not completed | 2 | 3 |
| Withdrew: Lost to follow-up | 0 | 3 |
| Withdrew: Protocol violation | 2 | 0 |
Total milk bacterial count at the end of the study (after probiotic administration for 21 days), measured as log10 of the number of colony-forming units per mL of milk
| log10 CFU/mL | Lactobacillus Salivarius PS2 | Lactobacillus Salivarius PS2B |
|---|---|---|
| Evidence of Clinically Definite Mastitis Confirmed by Microbiological Cultures and Somatic Cell Counts | 3.09 (2.90 to 3.28) | 2.90 (2.12 to 3.70) |
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Lactobacillus Salivarius PS2 | — | 0/25 (0%) | 0/25 (0%) |
| Lactobacillus Salivarius PS2B | — | 0/15 (0%) | 0/15 (0%) |
This study was designed to evaluate a high number of microbiological, biochemical or immunological parameters before and after the administration of a probiotic to women with mastitis and to elucidate which of them can be useful as biomarkers in future studies. The number of participants was considered suitable for such purpose.
| Age, Continuous(years) | Lactobacillus Salivarius PS2 | Lactobacillus Salivarius PS2B | Total |
|---|---|---|---|
| Mean | 28.2 ± 7.7 | 29.0 ± 7.8 | 28.6 ± 7.7 |
| Sex: Female, Male(Participants) | Lactobacillus Salivarius PS2 | Lactobacillus Salivarius PS2B | Total |
|---|---|---|---|
| Female | 25 | 15 | 40 |
| Male | 0 | 0 | 0 |
| Region of Enrollment(participants) | Lactobacillus Salivarius PS2 | Lactobacillus Salivarius PS2B | Total |
|---|---|---|---|
| Spain | 25 | 15 | 40 |
| Total milk bacterial count (initial)(log10 CFU/mL) | Lactobacillus Salivarius PS2 | Lactobacillus Salivarius PS2B | Total |
|---|---|---|---|
| Mean | 4.08 ± 0.20 | 3.19 ± 0.59 | 3.63 ± 0.39 |
The record gives a start of Mar 2011, a primary completion of Sep 2013 and a completion of Dec 2013. It does not say whether these dates are actual or estimated.
Results were first posted in Aug 2014, 11 months after primary completion.
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This study is completed, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.
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