CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 40 enrolled
Drug / intervention
Lactobacillus salivarius PS2 +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01124448
NCT01124448N/ACompleted

Oral Administration of a Probiotic to Lactating Women: Microbiological, Immunological, Transcriptomics and Metabolomics Effects

Universidad Complutense de Madrid·interventional·Posted May 17, 2010·Updated Aug 20, 2014

In Brief

A clinical study evaluating Lactobacillus salivarius PS2 for Mastitis. Completed, enrolled 40 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMastitis
CountriesSpain

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 17, 2010
Enrollment StartMar 1, 2011
Primary CompletionSep 1, 2013
Study CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 16.1 years ago

Interventions

Lactobacillus salivarius PS2biological

9.5 log10 (colony-forming units), freeze-dried powder, daily for 21 days

Lactobacillus salivarius PS2biological

9.5 log10 colony-forming units, oral route, freeze-dried powder, daily for 21 days