Evaluation of Lactobacillus Fermentum CECT5716 on the Incidence of Mastitis

August 11, 2016 updated by: Biosearch S.A.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

625

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Granada, Spain
        • Hospital Virgen de las Nieves

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
up to 16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
at times 0, 4, 8, 12 and 16 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
microbiota breast milk
Time Frame: at time 0 and 16 weeks
DNA will be extracted from breast milk samples. Staphylococcus genus, Streptococcus and Lactobacillus will be evaluated by qPCR with specific probes designed to quantify these bacterial genus.
at time 0 and 16 weeks
fecal microbiota of infants
Time Frame: at 0 and 16 weeks
DNA will be extracted from infant´s feces samples. Lactobacillus, bifidobacterium, clostridium, bacteroides will be evaluated by qPCR with specific probes designed to quantify these bacterial genus.
at 0 and 16 weeks
growth of infants
Time Frame: at 0 and 16 weeeks
Weight, length and head circumference will be measured in infants at the beginning and at 16 weeks
at 0 and 16 weeeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biosearch S.A.

Investigators

  • Study Chair: Juristo Fonollá, PhD, Biosearch S.A.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

July 29, 2014

First Submitted That Met QC Criteria

July 29, 2014

First Posted (Estimate)

July 30, 2014

Study Record Updates

Last Update Posted (Estimate)

August 12, 2016

Last Update Submitted That Met QC Criteria

August 11, 2016

Last Verified

July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P032

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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