NCT01124448 (PROBIOLAC) is a NA clinical trial of Lactobacillus salivarius PS2 in Mastitis, sponsored by Universidad Complutense de Madrid.

Who is sponsoring NCT01124448?

NCT01124448 is sponsored by Universidad Complutense de Madrid.

What drugs are being tested in NCT01124448?

Interventions in NCT01124448: Lactobacillus salivarius PS2, Lactobacillus salivarius PS2.

Is NCT01124448 still recruiting?

NCT01124448 is currently completed. Last updated 19 August 2014.

Are results published for NCT01124448?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2014-08-19 · How we verify

NCT01124448: PROBIOLAC

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed NA Results posted Last updated 19 August 2014

What this trial tests

NA trial testing Lactobacillus salivarius PS2 in Mastitis in 40 participants. Completed in 1 December 2013.

Timeline

1 March 2011

Primary endpoint
1 September 2013

1 December 2013

Quick facts

Lead sponsor	Universidad Complutense de Madrid
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	basic science
Enrollment	40
Start date	1 March 2011
Primary completion	1 September 2013
Estimated completion	1 December 2013
Sites	1 location across Spain

Drugs / interventions tested

Lactobacillus salivarius PS2 — full drug profile →
Lactobacillus salivarius PS2 — full drug profile →

Conditions studied

Mastitis — all drugs for Mastitis →

Sponsor

Universidad Complutense de Madrid — full company profile →

Who can join

Adults 18 to 45, female only, with Mastitis. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Evidence of Clinically Definite Mastitis Confirmed by Microbiological Cultures and Somatic Cell Counts
Time frame: one week
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

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

An Exploratory Search for Potential Molecular Targets Responsive to the Probiotic <i>Lactobacillus salivarius</i> PS2 in Women With Mastitis: Gene Expression Profiling vs. Interindividual Variability.
de Andrés J, Jiménez E, Espinosa-Martos I, Rodríguez JM, et al · · 2018 · cited 22× · PMID 30271395 · DOI 10.3389/fmicb.2018.02166

Verify or expand the search:

Other Universidad Complutense de Madrid trials

Trials by the same sponsor.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01124448 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Universidad Complutense de Madrid
Last refreshed: 19 August 2014

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01124448.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing