Evaluation of Lactobacillus Fermentum CECT5716 on the Incidence of Mastitis

N/ACompletedNCT02203877

Biosearch S.A.625 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

625

Conditions

Mastitis

Interventions

Lactobacillus fermentum CECT5716DIETARY_SUPPLEMENT

Intervention with a probiotic strain in form of a daily capsule containing 3x109cfu/capsule.

MaltodextrinDIETARY_SUPPLEMENT

Intervention with a daily capsule containing maltodextrin as placebo

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy women between 18 and 40 years with development of normal pregnancy Birth between 37 and 42 weeks of gestation. Women who have received antibiotic treatment between 48 hours before and 48 hours after childbirth (one dose is sufficient for inclusion regardless of the type of antibiotic). Childbirth took place 1-7 days prior to recruitment.. With firm intention to breast-feed their children for at least 16 weeks.. Exclusion Criteria: * \- Mammary pathologies that hinder or preclude breastfeeding. * Low expectation of adherence to the study protocol.

Locations (1)

Hospital Virgen de las Nieves

Granada, Granada, Spain

Outcomes

Primary Outcomes

incidence of mastitis

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)

Time frame: up to 16 weeks

Secondary Outcomes

evaluation of breast pain

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

Time frame: at times 0, 4, 8, 12 and 16 weeks

Data from ClinicalTrials.gov

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