Global Effects of a Probiotic Strain on Lactating Women (PROBIOLAC)
This study is currently recruiting participants.
Verified January 2012 by Universidad Complutense de Madrid
Sponsor:
Universidad Complutense de Madrid
Collaborator:
National Research Council, Spain
Information provided by (Responsible Party):
Juan M. Rodríguez, Universidad Complutense de Madrid
ClinicalTrials.gov Identifier:
NCT01124448
First received: May 14, 2010
Last updated: January 4, 2012
Last verified: January 2012
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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, proteomic 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 Biological: Milk powder |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) 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:
MedlinePlus related topics:
Breast Diseases
Drug Information available for:
Lactobacillus
U.S. FDA Resources
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 ]
Secondary Outcome Measures:
- Evidence of changes in gene expression of mononuclear cells obtained from blood samples [ Time Frame: one year ] [ Designated as safety issue: No ]
- Evidence of changes in the metabolic profile of plasma [ 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 metabolic profile of milk [ Time Frame: One year ] [ Designated as safety issue: No ]
- Evidence of changes in the metabolic profile of feces [ Time Frame: One year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | March 2012 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Lactobacillus salivarius PS2
Women with mastitis (n=20) receiving Lactobacillus salivarius PS2(9 log per day, 21 days)
|
Biological: Lactobacillus salivarius PS2
9 log10 (colony-forming units), freeze-dried powder, daily for 21 days
|
|
Active Comparator: Lactobacillus salivarius PS2B
Lactating women without mastitis (n=20)
|
Biological: Lactobacillus salivarius PS2
9 log10 colony-forming units, oral route, freeze-dried powder, daily for 21 days
|
|
Placebo Comparator: Milk powder
Lactating women without mastitis (n=20)
|
Biological: Milk powder
200 g, oral route, 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01124448
Contacts
| Contact: Juan M Rodríguez, PhD | 34913943837 | jmrodrig@vet.ucm.es |
Locations
| Spain | |
| Dpt. Nutricion, Bromatologia y Tecnologia de los Alimentos | Recruiting |
| Madrid, Spain, 28040 | |
| Contact: Juan M Rodriguez, PhD 34-91-3943837 jmrodrig@vet.ucm.es | |
| Principal Investigator: Juan M Rodriguez, PhD | |
| Sub-Investigator: Leonides Fernandez, PhD | |
Sponsors and Collaborators
Universidad Complutense de Madrid
National Research Council, Spain
Investigators
| Study Director: | Juan M Rodríguez, PhD | Universidad Complutense de Madrid |
More Information
Additional Information:
Publications:
| Responsible Party: | Juan M. Rodríguez, Professor, PhD, Universidad Complutense de Madrid |
| ClinicalTrials.gov Identifier: | NCT01124448 History of Changes |
| Other Study ID Numbers: | PROBIOLAC |
| Study First Received: | May 14, 2010 |
| Last Updated: | January 4, 2012 |
| Health Authority: | Spain: Comité Ético de Investigación Clínica |
Additional relevant MeSH terms:
|
Mastitis Puerperal Disorders Pregnancy Complications Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on May 23, 2013