Global Effects of a Probiotic Strain on Lactating Women

Not Applicable

Completed

• Conditions: Mastitis
• Interventions: Biological: Lactobacillus salivarius PS2

• Registration Number: NCT01124448
• Lead Sponsor: Universidad Complutense de Madrid

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-05-14
• Study First Submitted QC: 2010-05-14
• Study First Posted: 2010-05-17
• Study Start: 2011-03
• Primary Completion: 2013-09
• Study Completion: 2013-12
• Results First Submitted: 2014-07-03
• Status Verified: 2014-08
• Results First Submitted QC: 2014-08-19
• Last Update Submitted: 2014-08-19
• Results First Posted: 2014-08-20
• Last Update Posted: 2014-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lactobacillus salivarius PS2B	Lactobacillus salivarius PS2	Lactating women without mastitis (n=15)
Lactobacillus salivarius PS2	Lactobacillus salivarius PS2	Women with mastitis (n=25) receiving Lactobacillus salivarius PS2 (9.5 log per day, 21 days)

Primary Outcome Measures

Name	Time	Method
Evidence of Clinically Definite Mastitis Confirmed by Microbiological Cultures and Somatic Cell Counts	one week	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

Secondary Outcome Measures

Name	Time	Method
Evidence of Changes in Gene Expression of Somatic Cells Obtained From Milk Samples	one year
Evidence of Changes in the Immunological Profile of Milk	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

Trial Locations

Locations (1)

Dpt. Nutricion, Bromatologia y Tecnologia de los Alimentos; 🇪🇸 Madrid, Spain