Clinical trial NCT01124448: Global Effects of a Probiotic Strain on Lactating Women
Official title: Oral Administration of a Probiotic to Lactating Women: Microbiological, Immunological, Transcriptomics and Metabolomics Effects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mastitis
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
Collaborators: name: National Research Council, Spain
name: University of Valencia
name: Danone Global Research & Innovation Center
First posted: 2010-05-17
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Allergy to cow's milk protein
* Intolerance to lactose
* Antibiotic treatment
* Breast abscess
* Raynaud syndrome
* Any parallel disease

Primary outcomes:
measure: Evidence of Clinically Definite Mastitis Confirmed by Microbiological Cultures and Somatic Cell Counts
timeFrame: one week
Secondary outcomes:
measure: Evidence of Changes in Gene Expression of Somatic Cells Obtained From Milk Samples
timeFrame: one year
measure: Evidence of Changes in the Metabolic Profile of Urine
timeFrame: One year
measure: Evidence of Changes in the Macronutrient and Electrolyte Profiles of Milk
timeFrame: One year
measure: Evidence of Changes in the Immunological Profile of Milk
timeFrame: one year
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Dpt. Nutricion, Bromatologia y Tecnologia de los Alimentos
Study officials:
affiliation: Universidad Complutense de Madrid
name: Juan M Rodríguez, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Jimenez 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.
citation: Vazquez-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.