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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01124448
Recruitment Status : Completed
First Posted : May 17, 2010
Results First Posted : August 20, 2014
Last Update Posted : August 20, 2014
Sponsor:
Collaborators:
National Research Council, Spain
University of Valencia
Danone Research
Information provided by (Responsible Party):
Juan M. Rodríguez, Universidad Complutense de Madrid

Study Description
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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.

Condition or disease Intervention/treatment Phase
Mastitis Biological: Lactobacillus salivarius PS2 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Oral Administration of a Probiotic to Lactating Women: Microbiological, Immunological, Transcriptomics and Metabolomics Effects
Study Start Date : March 2011
Actual Primary Completion Date : September 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Diseases

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Evidence of Clinically Definite Mastitis Confirmed by Microbiological Cultures and Somatic Cell Counts [ Time Frame: 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 :
  1. Evidence of Changes in Gene Expression of Somatic Cells Obtained From Milk Samples [ Time Frame: one year ]
  2. Evidence of Changes in the Metabolic Profile of Urine [ Time Frame: One year ]
  3. Evidence of Changes in the Macronutrient and Electrolyte Profiles of Milk [ Time Frame: One year ]
  4. Evidence of Changes in the Immunological Profile of Milk [ Time Frame: one year ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01124448


Locations
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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
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Study Director: Juan M Rodríguez, PhD Universidad Complutense de Madrid
More Information
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Additional Information:

Publications of Results:

Other Publications:

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Responsible Party: Juan M. Rodríguez, Professor, PhD, Universidad Complutense de Madrid
ClinicalTrials.gov Identifier: NCT01124448    
Other Study ID Numbers: PROBIOLAC
First Posted: May 17, 2010    Key Record Dates
Results First Posted: August 20, 2014
Last Update Posted: August 20, 2014
Last Verified: August 2014
Additional relevant MeSH terms:
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Mastitis
Puerperal Disorders
Pregnancy Complications
Breast Diseases
Skin Diseases
 TFF1 protein, human
Growth Inhibitors
Growth Substances
Physiological Effects of Drugs