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OpenTrials
Completed

NCT Number: NCT01124448

Global Effects of a Probiotic Strain on Lactating Women

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.

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Key information

Conditions

Mastitis Breast Diseases Female Urogenital Diseases and Pregnancy Complications Pregnancy Complications Puerperal Disorders Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Dpt. Nutricion, Bromatologia y Tecnologia de los Alimentos

Madrid, 28040, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lactobacillus salivarius PS2

Biological

9.5 log10 (colony-forming units), freeze-dried powder, daily for 21 days

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Universidad Complutense de Madrid

Other

Collaborators

  • Danone Global Research & Innovation Center
  • National Research Council, Spain
  • University of Valencia

Registry information

Official study title

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

Acronym: PROBIOLAC

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
May 17, 2010
Registry last updated
Aug 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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