Global Effects of a Probiotic Strain on Lactating Women
PROBIOLAC
Oral Administration of a Probiotic to Lactating Women: Microbiological, Immunological, Transcriptomics and Metabolomics Effects
1 other identifier
interventional
40
1 country
1
Brief Summary
In this study, the investigators will try to confirm if application of probiotic strains isolated from breast milk actually have a beneficial effect on women suffering lactational mastitis. This project has been design to offer an integrated vision of the effects of probiotherapy (Lactobacillus salivarius PS2) on the human host. Therefore, the investigators propose a multidisciplinary approach involving the application of microbiological, immunological, genomic, metagenomic, transcriptomic and metabolomic techniques. The hypothesis is that probiotherapy will cause different effects on the host, and the objective is the finding of markers that may support the beneficial effect of the strain in such condition.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2011
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
First Submitted
Initial submission to the registry
May 14, 2010
CompletedFirst Posted
Study publicly available on registry
May 17, 2010
CompletedStudy Start
First participant enrolled
March 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedResults Posted
Study results publicly available
August 20, 2014
CompletedAugust 20, 2014
August 1, 2014
2.5 years
May 14, 2010
July 3, 2014
August 19, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Evidence of Clinically Definite Mastitis Confirmed by Microbiological Cultures and Somatic Cell Counts
Total milk bacterial count at the end of the study (after probiotic administration for 21 days), measured as log10 of the number of colony-forming units per mL of milk
one week
Secondary Outcomes (4)
Evidence of Changes in Gene Expression of Somatic Cells Obtained From Milk Samples
one year
Evidence of Changes in the Metabolic Profile of Urine
One year
Evidence of Changes in the Macronutrient and Electrolyte Profiles of Milk
One year
Evidence of Changes in the Immunological Profile of Milk
one year
Study Arms (2)
Lactobacillus salivarius PS2
EXPERIMENTALWomen with mastitis (n=25) receiving Lactobacillus salivarius PS2 (9.5 log per day, 21 days)
Lactobacillus salivarius PS2B
ACTIVE COMPARATORLactating women without mastitis (n=15)
Interventions
9.5 log10 (colony-forming units), freeze-dried powder, daily for 21 days
Eligibility Criteria
You may qualify if:
- Normal term pregnancy
- Lactating women
- Healthy breastfed infant
- Women with mastitis:
- Clinical symptoms of mastitis
- Painful breastfeeding
- Count of staphylococci, streptococci and/or corynebacteria in milk higher than 3,000 colony-forming units/mL
- Leukocyte count in milk higher 6 log10/mL
- Women without mastitis:
- No clinical symptoms of mastitis
- No painful breastfeeding
- Count of staphylococci, streptococci and/or corynebacteria in milk lower than 500 colony-forming units/mL
- Leukocyte count in milk lower 5 log10/mL
You may not qualify if:
- Allergy to cow's milk protein
- Intolerance to lactose
- Antibiotic treatment
- Breast abscess
- Raynaud syndrome
- Any parallel disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Universidad Complutense de Madridlead
- National Research Council, Spaincollaborator
- University of Valenciacollaborator
- Danone Global Research & Innovation Centercollaborator
Study Sites (1)
Dpt. Nutricion, Bromatologia y Tecnologia de los Alimentos
Madrid, Madrid, 28040, Spain
Related Publications (3)
Arroyo R, Martin V, Maldonado A, Jimenez E, Fernandez L, Rodriguez JM. Treatment of infectious mastitis during lactation: antibiotics versus oral administration of Lactobacilli isolated from breast milk. Clin Infect Dis. 2010 Jun 15;50(12):1551-8. doi: 10.1086/652763.
PMID: 20455694BACKGROUNDJimenez E, Fernandez L, Maldonado A, Martin R, Olivares M, Xaus J, Rodriguez JM. Oral administration of Lactobacillus strains isolated from breast milk as an alternative for the treatment of infectious mastitis during lactation. Appl Environ Microbiol. 2008 Aug;74(15):4650-5. doi: 10.1128/AEM.02599-07. Epub 2008 Jun 6.
PMID: 18539795BACKGROUNDVazquez-Fresno R, Llorach R, Marinic J, Tulipani S, Garcia-Aloy M, Espinosa-Martos I, Jimenez E, Rodriguez JM, Andres-Lacueva C. Urinary metabolomic fingerprinting after consumption of a probiotic strain in women with mastitis. Pharmacol Res. 2014 Sep;87:160-5. doi: 10.1016/j.phrs.2014.05.010. Epub 2014 May 29.
PMID: 24880136RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Juan M Rodríguez
- Organization
- Complutense University Madrid
Study Officials
- STUDY DIRECTOR
Juan M Rodríguez, PhD
Universidad Complutense de Madrid
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, PhD
Study Record Dates
First Submitted
May 14, 2010
First Posted
May 17, 2010
Study Start
March 1, 2011
Primary Completion
September 1, 2013
Study Completion
December 1, 2013
Last Updated
August 20, 2014
Results First Posted
August 20, 2014
Record last verified: 2014-08