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Global Effects of a Probiotic Strain on Lactating Women (PROBIOLAC)

This study has been completed.
Sponsor:
Collaborators:
National Research Council, Spain
University of Valencia
Danone Research
Information provided by (Responsible Party):
Juan M. Rodríguez, Universidad Complutense de Madrid
ClinicalTrials.gov Identifier:
NCT01124448
First received: May 14, 2010
Last updated: August 19, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Mastitis
Biological: Lactobacillus salivarius PS2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Oral Administration of a Probiotic to Lactating Women: Microbiological, Immunological, Transcriptomics and Metabolomics Effects

Resource links provided by NLM:


Further study details as provided by Universidad Complutense de Madrid:

Primary Outcome Measures:
  • Evidence of Clinically Definite Mastitis Confirmed by Microbiological Cultures and Somatic Cell Counts [ Time Frame: one week ] [ Designated as safety issue: No ]
    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:
  • Evidence of Changes in Gene Expression of Somatic Cells Obtained From Milk Samples [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Evidence of Changes in the Metabolic Profile of Urine [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Evidence of Changes in the Macronutrient and Electrolyte Profiles of Milk [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Evidence of Changes in the Immunological Profile of Milk [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: March 2011
Study Completion Date: December 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lactobacillus salivarius PS2
Women with mastitis (n=25) receiving Lactobacillus salivarius PS2 (9.5 log per day, 21 days)
Biological: Lactobacillus salivarius PS2
9.5 log10 (colony-forming units), freeze-dried powder, daily for 21 days
Active Comparator: Lactobacillus salivarius PS2B
Lactating women without mastitis (n=15)
Biological: Lactobacillus salivarius PS2
9.5 log10 colony-forming units, oral route, freeze-dried powder, daily for 21 days

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01124448

Locations
Spain
Dpt. Nutricion, Bromatologia y Tecnologia de los Alimentos
Madrid, Spain, 28040
Sponsors and Collaborators
Universidad Complutense de Madrid
National Research Council, Spain
University of Valencia
Danone Research
Investigators
Study Director: Juan M Rodríguez, PhD Universidad Complutense de Madrid