NCT02203877

Evaluation of Lactobacillus Fermentum CECT5716 on the Incidence of Mastitis

Nutritional Intervention Study, Randomized, Double-blind, Parallel Group to Evaluate the Effect of Lactobacillus Fermentum CECT5716 Consumption on the Incidence of Mastitis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 625 (actual)
• Sponsor: Biosearch S.A. · Industry
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

To evaluate the effect of the consumption of Lactobacillus fermentum CECT5716 on mastitis incidence.

Detailed description

Previous studies have demonstrated that L. fermentum CECT5716, a probiotic strain previously isolated from breast milk, can be used as an effective treatment of mastitis and painful breastfeeding by reducing pathogen counts in breast milk. This is a randomized double blinded controlled study to evaluate the effect of L.fermentum CECT5716 on mastitis incidence and Staphylococcus load in breast milk. Women will be recruited 1-6 days after child birth and distributed into two groups: Probiotic group receiving 1 capsule/day containing L.fermentum 3x109cfu; Control group receiving 1 placebo capsule/day containing maltodextrin. The intervention period is 16 weeks.

Conditions

• Mastitis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Lactobacillus fermentum CECT5716	Intervention with a probiotic strain in form of a daily capsule containing 3x109cfu/capsule.
DIETARY_SUPPLEMENT	Maltodextrin	Intervention with a daily capsule containing maltodextrin as placebo

Timeline

• Start date: 2013-08-01
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2014-07-30
• Last updated: 2016-08-12

Locations

1 site across 1 country: Spain