Clinical Trial: Evaluation of Lactobacillus Fermentum CECT5716 on the Incidence of Mastitis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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

Detailed Summary: 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.
Sponsor: Biosearch S.A.

Current Primary Outcome: incidence of mastitis [ Time Frame: up to 16 weeks ]

mastitis was defined as at least two out of the three breast symptoms (pain, redness, lump) and at least one of fever or flu-like symptoms (shivering, hot sweats or aches)


Original Primary Outcome: incidence of mastitis [ Time Frame: up to 16 weeks ]

Current Secondary Outcome: evaluation of breast pain [ Time Frame: at times 0, 4, 8, 12 and 16 weeks ]

For pain evaluation a score from 1 (no pain) to 10 (extremely pain)


Original Secondary Outcome: evaluation of breast pain [ Time Frame: at times 0, 4, 8, 12 and 16 weeks ]

Information By: Biosearch S.A.

Dates:
Date Received: July 29, 2014
Date Started: August 2013
Date Completion:
Last Updated: August 11, 2016
Last Verified: July 2014