Evaluation of Lactobacillus Fermentum CECT5716 on the Incidence of Mastitis

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Mastitis

Intervention / Treatment
-----------------
* Dietary Supplement: Lactobacillus fermentum CECT5716
* Dietary Supplement: Maltodextrin


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Maltodextrin<br>1 capsule/day for 16 weeks | Dietary Supplement: Maltodextrin<br>* Intervention with a daily capsule containing maltodextrin as placebo<br>|
| Experimental: Lactobacillus fermentum CECT5716<br>L.fermentum 3,00E+09cfu/day. 1 capsule/day for 16 weeks | Dietary Supplement: Lactobacillus fermentum CECT5716<br>* Intervention with a probiotic strain in form of a daily capsule containing 3x109cfu/capsule.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | up to 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluation of breast pain | For pain evaluation a score from 1 (no pain) to 10 (extremely pain) | at times 0, 4, 8, 12 and 16 weeks |