Evaluation of Lactobacillus Fermentum CECT5716 on the Incidence of Mastitis
Nutritional Intervention Study, Randomized, Double-blind, Parallel Group to Evaluate the Effect of Lactobacillus Fermentum CECT5716 Consumption on the Incidence of Mastitis
1 other identifier
interventional
625
1 country
1
Brief Summary
To evaluate the effect of the consumption of Lactobacillus fermentum CECT5716 on mastitis incidence.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 29, 2014
CompletedFirst Posted
Study publicly available on registry
July 30, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedAugust 12, 2016
July 1, 2014
2 years
July 29, 2014
August 11, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
evaluation of breast pain
at times 0, 4, 8, 12 and 16 weeks
Other Outcomes (3)
microbiota breast milk
at time 0 and 16 weeks
fecal microbiota of infants
at 0 and 16 weeks
growth of infants
at 0 and 16 weeeks
Study Arms (2)
Maltodextrin
PLACEBO COMPARATOR1 capsule/day for 16 weeks
Lactobacillus fermentum CECT5716
EXPERIMENTALL.fermentum 3,00E+09cfu/day. 1 capsule/day for 16 weeks
Interventions
Intervention with a probiotic strain in form of a daily capsule containing 3x109cfu/capsule.
Intervention with a daily capsule containing maltodextrin as placebo
Eligibility Criteria
You may qualify if:
- Childbirth took place 1-7 days prior to recruitment.. With firm intention to breast-feed their children for at least 16 weeks..
You may not qualify if:
- \- Mammary pathologies that hinder or preclude breastfeeding.
- Low expectation of adherence to the study protocol.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biosearch S.A.lead
Study Sites (1)
Hospital Virgen de las Nieves
Granada, Granada, Spain
Related Publications (2)
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.
PMID: 32987448DERIVEDPastor-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.
PMID: 32216468DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Juristo Fonollá, PhD
Biosearch S.A.
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 29, 2014
First Posted
July 30, 2014
Study Start
August 1, 2013
Primary Completion
August 1, 2015
Study Completion
August 1, 2015
Last Updated
August 12, 2016
Record last verified: 2014-07
Data Sharing
- IPD Sharing
- Will not share