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Completed

NCT Number: NCT02203877

Evaluation of Lactobacillus Fermentum CECT5716 on the Incidence of Mastitis

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

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Key information

Conditions

Mastitis Breast Diseases Female Urogenital Diseases and Pregnancy Complications Pregnancy Complications Puerperal Disorders Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Virgen de las Nieves

Granada, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lactobacillus fermentum CECT5716

Dietary Supplement

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

Maltodextrin

Dietary Supplement

Intervention with a daily capsule containing maltodextrin as placebo

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

Other outcomes

  1. 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.

  2. 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.

  3. 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

Sponsors and collaborators

Lead sponsor

Biosearch S.A.

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jul 30, 2014
Registry last updated
Aug 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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