Clinical trial NCT02203877: Evaluation of Lactobacillus Fermentum CECT5716 on the Incidence of Mastitis
Official title: Nutritional Intervention Study, Randomized, Double-blind, Parallel Group to Evaluate the Effect of Lactobacillus Fermentum CECT5716 Consumption on the Incidence of Mastitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mastitis
Lead sponsor: Biosearch S.A.
Sponsor class: INDUSTRY
First posted: 2014-07-30
Enrollment: 625
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: incidence of mastitis
timeFrame: up to 16 weeks
Secondary outcomes:
measure: evaluation of breast pain
timeFrame: at times 0, 4, 8, 12 and 16 weeks
Other outcomes:
measure: microbiota breast milk
timeFrame: at time 0 and 16 weeks
measure: fecal microbiota of infants
timeFrame: at 0 and 16 weeks
measure: growth of infants
timeFrame: at 0 and 16 weeeks
Locations:
city: Granada
country: Spain
facility: Hospital Virgen de las Nieves
Study officials:
affiliation: Biosearch S.A.
name: Juristo Fonollá, PhD
role: STUDY_CHAIR
References:
citation: Crepinsek MA, Taylor EA, Michener K, Stewart F. Interventions for preventing mastitis after childbirth. Cochrane Database Syst Rev. 2020 Sep 29;9(9):CD007239. doi: 10.1002/14651858.CD007239.pub4.
citation: Pastor-Villaescusa B, Hurtado JA, Gil-Campos M, Uberos J, Maldonado-Lobon JA, Diaz-Ropero MP, Banuelos O, Fonolla J, Olivares M; PROLAC Group. Effects of Lactobacillus fermentum CECT5716 Lc40 on infant growth and health: a randomised clinical trial in nursing women. Benef Microbes. 2020 May 11;11(3):235-244. doi: 10.3920/BM2019.0180. Epub 2020 Mar 27.