L.Fermentum CECT5716 in Treatment of Breast Pain
Study of Intervention Nutritional, Multicenter, Randomized, Blind, Parallel Group to Evaluate the Efficacy of Lactobacillus Fermentum CECT5716 to Reduce the Load Bacterial in Potential Pathogens in Milk of Mothers With Breast Pain
1 other identifier
interventional
127
1 country
1
Brief Summary
The main objective of this intervention study is to evaluate the efficacy of Lactobacillus fermentum CECT5716 to reduce the presence in the milk of genera Staphylococcus and Streptococcus as risk factors for mastitis in women with breast pain
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 18, 2013
CompletedFirst Posted
Study publicly available on registry
March 21, 2014
CompletedMarch 21, 2014
March 1, 2014
1.8 years
July 18, 2013
March 19, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline Staphylococcus count at 3 weeks
Counts of Staphylococcus in breast milk
0, 3 weeks
Secondary Outcomes (2)
Change from baseline Streptococcus counts at 3 weeks
0, 3 weeks
Change from Breast pain score at 3 weeks
0, 3 weeks
Study Arms (4)
fermentum 3x
EXPERIMENTALLactobacillus fermentum CECT5716 at 3x10e9 cfu/day
fermentum 6x
EXPERIMENTALLactobacillus fermentum CECT5716 at 6x10e9cfu/day
fermentum 9x
EXPERIMENTALLactobacillus fermentum CECT5716 at 9x10e9cfu/day
maltodextrin
PLACEBO COMPARATORmaltodextrin
Interventions
Eligibility Criteria
You may qualify if:
- · breast-feeding women
- Swelling and / or warmth in the chest
- Chest pain
- total bacteria count in milk greater than or equal to 3 log10 colony forming units (CFU) / mL,
You may not qualify if:
- breast abscesses, Raynaud syndrome,
- Antibiotic treatment
- Allergic to antibiotics
- Low expectation of compliance with the study protocol.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biosearch S.A.lead
- Junta de Andaluciacollaborator
- Statistical analysis: SEPLIN Soluciones Estadísticascollaborator
Study Sites (1)
Hospital Virgen de las Nieves
Granada, Granada, 18012, Spain
Related Publications (1)
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: 32987448DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dr. Miguel A Díaz López, Doctor
Gynecology Service of Virgen de las Nieves Hospital, Granada (Spain)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 18, 2013
First Posted
March 21, 2014
Study Start
July 1, 2011
Primary Completion
April 1, 2013
Study Completion
April 1, 2013
Last Updated
March 21, 2014
Record last verified: 2014-03