NCT01505361: PROBIOPREG

Oral Administration of a Probiotic Strain to Pregnant Women: Effects on the Prevention of Lactational Mastitis and on the Eradication of GBS Colonization

Status unknown Phase 1/Phase 2 Last updated 11 January 2012

What this trial tests

Phase 1/Phase 2 trial testing Lactobacillus salivarius PS2 in Mastitis in 100 participants. Status unknown.

Timeline

1 November 2011

Primary endpoint
1 March 2012

1 June 2012

Quick facts

Lead sponsor	Universidad Complutense de Madrid
Phase	Phase 1/Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	100
Start date	1 November 2011
Primary completion	1 March 2012
Estimated completion	1 June 2012
Sites	1 location across Spain

Drugs / interventions tested

• Lactobacillus salivarius PS2 — full drug profile →
• Excipient (milk powder) — full drug profile →

Conditions studied

• Mastitis — all drugs for Mastitis →

Sponsor

Universidad Complutense de Madrid — full company profile →

Who can join

Adults 25 to 35, 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 clinical mastitis confirmed by microbiological cultures and somatic cell counts
  Time frame: Weekly during the first 6 months after birth

Sponsor's own description

In previous studies, the investigators have seen that carefully-selected Lactobacillus strains are a good alternative to antibiotics for the treatment of lactational mastitis. The objective of this new study is to check if they can also have a preventive role when administered to women with a history of mastitis with one or more previous infants. Since the investigators have also realized that peripartum antibiotherapy (mainly GBS-targeting intrapartum prophylaxis)is a predisposing factor for mastitis (because of the selection of resistant bacteria), the investigators would also like to test if administration of the strains to GBS-colonized pregnant women may lead to GBS eradication. Therefore, a mastitis-predisposing factor would de avoid.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Prevention of Infectious Mastitis by Oral Administration of Lactobacillus salivarius PS2 During Late Pregnancy.
   Fernández L, Cárdenas N, Arroyo R, Manzano S, et al · · 2016 · cited 106× · PMID 26611780 · DOI 10.1093/cid/civ974
2. Maternal probiotic supplementation for prevention of morbidity and mortality in preterm infants.
   Grev J, Berg M, Soll R. · · 2018 · cited 34× · PMID 30548483 · DOI 10.1002/14651858.cd012519.pub2
3. Reporting of Perinatal Outcomes in Probiotic Randomized Controlled Trials. A Systematic Review and Meta-Analysis.
   Pérez-Castillo ÍM, Fernández-Castillo R, Lasserrot-Cuadrado A, Gallo-Vallejo JL, et al · · 2021 · cited 14× · PMID 33477352 · DOI 10.3390/nu13010256