Global Effects of a Probiotic Strain on Lactating Women

Mastitis Clinical Trial

— PROBIOLAC  

Official title:

Oral Administration of a Probiotic to Lactating Women: Microbiological, Immunological, Transcriptomics and Metabolomics Effects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01124448
• Other study ID #: PROBIOLAC
• Status: Completed
• Phase: N/A
• First received: May 14, 2010
• Last updated: August 19, 2014
• Start date: March 2011
• Est. completion date: December 2013

Study information

• Verified date: August 2014
• Source: Universidad Complutense de Madrid
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Mastitis

Intervention

Biological:
• Lactobacillus salivarius PS2
9.5 log10 (colony-forming units), freeze-dried powder, daily for 21 days
• Lactobacillus salivarius PS2
9.5 log10 colony-forming units, oral route, freeze-dried powder, daily for 21 days

Locations

Country	Name	City	State
Spain	Dpt. Nutricion, Bromatologia y Tecnologia de los Alimentos	Madrid

Sponsors (4)

Lead Sponsor	Collaborator
Universidad Complutense de Madrid	Danone Research, National Research Council, Spain, University of Valencia

Country where clinical trial is conducted

Spain, 

References & Publications (3)

Arroyo R, Martín V, Maldonado A, Jiménez E, Fernández L, Rodríguez 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. — View Citation

Jiménez E, Fernández L, Maldonado A, Martín R, Olivares M, Xaus J, Rodríguez 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. — View Citation

Vázquez-Fresno R, Llorach R, Marinic J, Tulipani S, Garcia-Aloy M, Espinosa-Martos I, Jiménez E, Rodríguez JM, Andres-Lacueva C. Urinary metabolomic fingerprinting after consumption of a probiotic strain in women with mastitis. Pharmacol Res. 2014 Sep;87: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Evidence of Changes in Gene Expression of Somatic Cells Obtained From Milk Samples		one year	No
Secondary	Evidence of Changes in the Metabolic Profile of Urine		One year	No
Secondary	Evidence of Changes in the Macronutrient and Electrolyte Profiles of Milk		One year	No
Secondary	Evidence of Changes in the Immunological Profile of Milk		one year	No

External Links

•   website of the research group