Evaluation of Lactobacillus Fermentum CECT5716 on the Incidence of Mastitis

Biosearch Life

Status: Completed

Conditions: Mastitis

Treatments: Dietary Supplement: Maltodextrin; Dietary Supplement: Lactobacillus fermentum CECT5716

Study type: Interventional

Funder types: Industry

Identifiers

NCT02203877

P032

Details and patient eligibility

About

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

Full 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.

Enrollment: 625 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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625 participants in 2 patient groups, including a placebo group

Maltodextrin

Placebo Comparator group

Description:

1 capsule/day for 16 weeks

Treatment:

Dietary Supplement: Maltodextrin

Lactobacillus fermentum CECT5716

Experimental group

Description:

L.fermentum 3,00E+09cfu/day. 1 capsule/day for 16 weeks

Treatment:

Dietary Supplement: Lactobacillus fermentum CECT5716