MastitisPROBIOLACNCT01124448
Global Effects of a Probiotic Strain on Lactating Women
A study testing Lactobacillus salivarius PS2 in people with Mastitis, run by Universidad Complutense de Madrid at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mastitis
- What is being tested?
- Lactobacillus salivarius PS2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2011to Dec 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normal term pregnancy
- Lactating women
- Healthy breastfed infant
- Women with mastitis:
- Clinical symptoms of mastitis
- Painful breastfeeding
Show all 13Show fewer
- 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
Who cannot join
- Allergy to cow's milk protein
- Intolerance to lactose
- Antibiotic treatment
- Breast abscess
- Raynaud syndrome
- Any parallel disease
Trial locations and contacts
1 site in 1 country.
Spain1 site
Dpt. Nutricion, Bromatologia y Tecnologia de los Alimentos
Madrid, Madrid, 28040
About this study
Official title: Oral Administration of a Probiotic to Lactating Women: Microbiological, Immunological, Transcriptomics and Metabolomics Effects
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.
- Conditions
- Mastitis
- Being tested
- Lactobacillus salivarius PS2
- Medical subject headings
- Mastitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus salivarius PS2Biological
9.5 log10 (colony-forming units), freeze-dried powder, daily for 21 days
Lactobacillus salivarius PS2Biological
9.5 log10 colony-forming units, oral route, freeze-dried powder, daily for 21 days
| Study group | Role | What they receive |
|---|---|---|
| Lactobacillus salivarius PS2 | Experimental | Women with mastitis (n=25) receiving Lactobacillus salivarius PS2 (9.5 log per day, 21 days) Receives: Biological: Lactobacillus salivarius PS2 |
| Lactobacillus salivarius PS2B | Active comparator | Lactating women without mastitis (n=15) Receives: Biological: Lactobacillus salivarius PS2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of Clinically Definite Mastitis Confirmed by Microbiological Cultures and Somatic Cell Counts
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
Measured: one week
Secondary outcomes (4)
Evidence of Changes in Gene Expression of Somatic Cells Obtained From Milk Samples
Measured: one year
Evidence of Changes in the Metabolic Profile of Urine
Measured: One year
Evidence of Changes in the Macronutrient and Electrolyte Profiles of Milk
Measured: One year
Evidence of Changes in the Immunological Profile of Milk
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2010 (estimated)
- Study startMar 2011
- Primary completionSep 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for MastitisStudies of the same condition, open and under way.
- More trials run by Universidad Complutense de MadridThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Council, Spain, University of Valencia, Danone Global Research & Innovation Center
- Responsible party
- Principal investigator, Juan M. Rodríguez, Universidad Complutense de Madrid
- Investigators
- Juan M Rodríguez, PhD, Study director, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01124448
- Sponsor's protocol ID
- PROBIOLAC
- Acronym
- PROBIOLAC
- Status last verified
- Aug 2014
- First submitted
- 14 May 2010
- Last updated
- 20 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Arroyo R, Martin V, Maldonado A, Jimenez E, Fernandez L, Rodriguez JM. Treatment of infectious mastitis during lactation: antibiotics versus oral administration of Lactobacilli isolated from breast milk. Clin Infect Dis. 2010 Jun 15;50(12):1551-8. doi: 10.1086/652763.
PubMed 20455694Jimenez E, Fernandez L, Maldonado A, Martin R, Olivares M, Xaus J, Rodriguez JM. Oral administration of Lactobacillus strains isolated from breast milk as an alternative for the treatment of infectious mastitis during lactation. Appl Environ Microbiol. 2008 Aug;74(15):4650-5. doi: 10.1128/AEM.02599-07. Epub 2008 Jun 6.
PubMed 18539795Vazquez-Fresno R, Llorach R, Marinic J, Tulipani S, Garcia-Aloy M, Espinosa-Martos I, Jimenez E, Rodriguez JM, Andres-Lacueva C. Urinary metabolomic fingerprinting after consumption of a probiotic strain in women with mastitis. Pharmacol Res. 2014 Sep;87:160-5. doi: 10.1016/j.phrs.2014.05.010. Epub 2014 May 29.
PubMed 24880136
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Administration of a Probiotic to Lactating Women: Microbiological, Immunological, Transcriptomics and Metabolomics Effects
- ClinicalTrials.gov ID
- NCT01124448
- Acronym / sponsor ID
- PROBIOLAC / PROBIOLAC
- Conditions
- Mastitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Collaborators
- National Research Council, Spain, University of Valencia, Danone Global Research & Innovation Center
- Study start
- Mar 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 17 May 2010 (estimated)
- Results
- Posted 20 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactobacillus salivarius PS2 | Experimental | Biological: Lactobacillus salivarius PS2Women with mastitis (n=25) receiving Lactobacillus salivarius PS2 (9.5 log per day, 21 days) |
| Lactobacillus salivarius PS2B | Active comparator | Biological: Lactobacillus salivarius PS2Lactating women without mastitis (n=15) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Normal term pregnancy
- Lactating women
- Healthy breastfed infant
- Clinical symptoms of mastitis
- Painful breastfeeding
Key exclusion criteria (6 listed)
- Allergy to cow's milk protein
- Intolerance to lactose
- Antibiotic treatment
- Breast abscess
- Raynaud syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactobacillus salivarius PS29.5 log10 (colony-forming units), freeze-dried powder, daily for 21 days | Biological | Lactobacillus salivarius PS2 |
| Lactobacillus salivarius PS29.5 log10 colony-forming units, oral route, freeze-dried powder, daily for 21 days | Biological | Lactobacillus salivarius PS2B |
Primary outcome
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
4 secondary outcomes
Evidence of Changes in Gene Expression of Somatic Cells Obtained From Milk Samples
Time frame: one year
Evidence of Changes in the Metabolic Profile of Urine
Time frame: One year
Evidence of Changes in the Macronutrient and Electrolyte Profiles of Milk
Time frame: One year
Evidence of Changes in the Immunological Profile of Milk
Time frame: one year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20455694Arroyo R, Martin V, Maldonado A, Jimenez E, Fernandez L, Rodriguez JM. Treatment of infectious mastitis during lactation: antibiotics versus oral administration of Lactobacilli isolated from breast milk. Clin Infect Dis. 2010 Jun 15;50(12):1551-8. doi: 10.1086/652763.
- Background: PubMed 18539795Jimenez E, Fernandez L, Maldonado A, Martin R, Olivares M, Xaus J, Rodriguez JM. Oral administration of Lactobacillus strains isolated from breast milk as an alternative for the treatment of infectious mastitis during lactation. Appl Environ Microbiol. 2008 Aug;74(15):4650-5. doi: 10.1128/AEM.02599-07. Epub 2008 Jun 6.
- Results publication: PubMed 24880136Vazquez-Fresno R, Llorach R, Marinic J, Tulipani S, Garcia-Aloy M, Espinosa-Martos I, Jimenez E, Rodriguez JM, Andres-Lacueva C. Urinary metabolomic fingerprinting after consumption of a probiotic strain in women with mastitis. Pharmacol Res. 2014 Sep;87:160-5. doi: 10.1016/j.phrs.2014.05.010. Epub 2014 May 29.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan M Rodríguez, PhD study director
Universidad Complutense de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus salivarius PS2 in people with Mastitis, run by Universidad Complutense de Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence of Clinically Definite Mastitis Confirmed by Microbiological Cultures and Somatic Cell Counts (time frame: one week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01124448, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2014.