Global Effects of a Probiotic Strain on Lactating Women

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01124448
• Date of registration: 14/05/2010
• Primary sponsor: Universidad Complutense de Madrid
• Public title: Global Effects of a Probiotic Strain on Lactating Women PROBIOLAC
• Scientific title: Oral Administration of a Probiotic to Lactating Women: Microbiological, Immunological, Transcriptomics and Metabolomics Effects
• Date of first enrolment: March 2011
• Target sample size: 60
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01124448
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Countries of recruitment

Spain

Contacts

• Name: Juan M Rodriguez, PhD

• Name: Juan M Rodríguez, PhD

• Name: Juan M Rodríguez, PhD
• Affiliation: Universidad Complutense de Madrid

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Mastitis

Intervention(s)

Biological: Lactobacillus salivarius PS2

Biological: Milk powder

Primary Outcome(s)

Evidence of clinically definite mastitis confirmed by microbiological cultures and somatic cell counts [Time Frame: one week]

Secondary Outcome(s)

Evidence of changes in gene expression of mononuclear cells obtained from blood samples [Time Frame: one year]

Evidence of changes in the metabolic profile of feces [Time Frame: One year]

Evidence of changes in the metabolic profile of milk [Time Frame: One year]

Evidence of changes in the metabolic profile of plasma [Time Frame: One year]

Evidence of changes in the metabolic profile of urine [Time Frame: One year]

Secondary ID(s)

PROBIOLAC

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Research Council, Spain