MastitisPhase 1/2PROBIOPREGNCT01505361
Study of a Probiotic Strain to Prevent Mastitis and to Eradicate GBS Colonization
A Phase 1/2 study testing Lactobacillus salivarius PS2 and Excipient (milk powder) in people with Mastitis, run by Universidad Complutense de Madrid at 1 site in Spain.
Trial summary
In previous studies, the investigators have seen that carefully-selected Lactobacillus strains are a good alternative to antibiotics for the treatment of lactational mastitis. The objective of this new study is to check if they can also have a preventive role when administered to women with a history of mastitis with… Read more about this study
- Who is it for?
- Ages 25 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mastitis
- What is being tested?
- Lactobacillus salivarius PS2 and Excipient (milk powder)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2011to Jun 2012
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 25 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normal pregnancy
- Healthy women
- Lactational mastitis in, at least, a previous lactation period
- No symptomatic vaginal infections
Who cannot join
- Any kind of health problems related to pregnancy
- Symptomatic vaginal infections
- Allergy to cow's milk protein
- Intolerance to lactose
- Antibiotic treatment
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Public Primary Health Care Centers network
Madrid, Madrid, 28040
Juan M Rodriguez, PhD
Leonides Fernández, PhD
About this study
Official title: Oral Administration of a Probiotic Strain to Pregnant Women: Effects on the Prevention of Lactational Mastitis and on the Eradication of GBS Colonization
In previous studies, the investigators have seen that carefully-selected Lactobacillus strains are a good alternative to antibiotics for the treatment of lactational mastitis. The objective of this new study is to check if they can also have a preventive role when administered to women with a history of mastitis with one or more previous infants. Since the investigators have also realized that peripartum antibiotherapy (mainly GBS-targeting intrapartum prophylaxis)is a predisposing factor for mastitis (because of the selection of resistant bacteria), the investigators would also like to test if administration of the strains to GBS-colonized pregnant women may lead to GBS eradication. Therefore, a mastitis-predisposing factor would de avoid.
- Conditions
- Mastitis
- Being tested
- Lactobacillus salivarius PS2, Excipient (milk powder)
- Keywords
- probiotic, Lactobacillus salivarius, mastitis, prevention, group B streptococci, intrapartum prophylaxis
- 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 log10 (colony-forming units), freeze-dried powder, daily for 30 week of pregnancy until birth
Excipient (milk powder)Biological
100 mg/once a day from 30 week of pregnancy until birth
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | Pregnant women at 30 week of pregnancy(n=50) receiving Lactobacillus salivarius PS2(9 log per day, until birth) Receives: Biological: Lactobacillus salivarius PS2 |
| Placebo | Placebo comparator | Pregnant women at 30 week of pregnancy(n=50) receiving the excipient (once a day, until birth) Receives: Biological: Excipient (milk powder) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of clinical mastitis confirmed by microbiological cultures and somatic cell counts
Measured: Weekly during the first 6 months after birth
Secondary outcomes (1)
Evidence of eradication og GBS colonization as confirmed by microbiological analysis of vaginal exudate and rectal swab
Measured: At weeks 30, 35, 40 of pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2012 (estimated)
- Study startNov 2011
- Primary completionMar 2012 (estimated)
- Study completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan M. Rodríguez, Universidad Complutense de Madrid
- Investigators
- Juan M Rodriguez, PhD, Principal investigator, Complutense University of Madrid, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01505361
- Sponsor's protocol ID
- PROBIOPREG
- Acronym
- PROBIOPREG
- Status last verified
- Jan 2012
- First submitted
- 4 Jan 2012
- Last updated
- 12 Jan 2012
- Results posted
- No
- 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 18539795Crepinsek MA, Taylor EA, Michener K, Stewart F. Interventions for preventing mastitis after childbirth. Cochrane Database Syst Rev. 2020 Sep 29;9(9):CD007239. doi: 10.1002/14651858.CD007239.pub4.
PubMed 32987448Fernandez L, Cardenas N, Arroyo R, Manzano S, Jimenez E, Martin V, Rodriguez JM. Prevention of Infectious Mastitis by Oral Administration of Lactobacillus salivarius PS2 During Late Pregnancy. Clin Infect Dis. 2016 Mar 1;62(5):568-573. doi: 10.1093/cid/civ974. Epub 2015 Nov 26.
PubMed 26611780
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Administration of a Probiotic Strain to Pregnant Women: Effects on the Prevention of Lactational Mastitis and on the Eradication of GBS Colonization
- ClinicalTrials.gov ID
- NCT01505361
- Acronym / sponsor ID
- PROBIOPREG / PROBIOPREG
- Conditions
- Mastitis
- Keywords
- probiotic, Lactobacillus salivarius, mastitis, prevention, group B streptococci, intrapartum prophylaxis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Mar 2012 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 6 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In previous studies, the investigators have seen that carefully-selected Lactobacillus strains are a good alternative to antibiotics for the treatment of lactational mastitis. The objective of this new study is to check if they can also have a preventive role when administered to women with a history of mastitis with one or more previous infants. Since the investigators have also realized that peripartum antibiotherapy (mainly GBS-targeting intrapartum prophylaxis)is a predisposing factor for mastitis (because of the selection of resistant bacteria), the investigators would also like to test if administration of the strains to GBS-colonized pregnant women may lead to GBS eradication. Therefore, a mastitis-predisposing factor would de avoid.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Biological: Lactobacillus salivarius PS2Pregnant women at 30 week of pregnancy(n=50) receiving Lactobacillus salivarius PS2(9 log per day, until birth) |
| Placebo | Placebo comparator | Biological: Excipient (milk powder)Pregnant women at 30 week of pregnancy(n=50) receiving the excipient (once a day, until birth) |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Normal pregnancy
- Healthy women
- Lactational mastitis in, at least, a previous lactation period
- No symptomatic vaginal infections
Key exclusion criteria (5 listed)
- Any kind of health problems related to pregnancy
- Symptomatic vaginal infections
- Allergy to cow's milk protein
- Intolerance to lactose
- Antibiotic treatment
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 log10 (colony-forming units), freeze-dried powder, daily for 30 week of pregnancy until birth | Biological | Probiotic |
| Excipient (milk powder)100 mg/once a day from 30 week of pregnancy until birth | Biological | Placebo |
Primary outcome
Evidence of clinical mastitis confirmed by microbiological cultures and somatic cell counts
Time frame: Weekly during the first 6 months after birth
1 secondary outcome
Evidence of eradication og GBS colonization as confirmed by microbiological analysis of vaginal exudate and rectal swab
Time frame: At weeks 30, 35, 40 of pregnancy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2012.
- 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.
- Derived from this study: PubMed 32987448Crepinsek MA, Taylor EA, Michener K, Stewart F. Interventions for preventing mastitis after childbirth. Cochrane Database Syst Rev. 2020 Sep 29;9(9):CD007239. doi: 10.1002/14651858.CD007239.pub4.
- Derived from this study: PubMed 26611780Fernandez L, Cardenas N, Arroyo R, Manzano S, Jimenez E, Martin V, Rodriguez JM. Prevention of Infectious Mastitis by Oral Administration of Lactobacillus salivarius PS2 During Late Pregnancy. Clin Infect Dis. 2016 Mar 1;62(5):568-573. doi: 10.1093/cid/civ974. Epub 2015 Nov 26.
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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 Rodriguez, PhD principal investigator
Complutense University of Madrid, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Lactobacillus salivarius PS2 and Excipient (milk powder) 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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 12 Jan 2012. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juan M Rodríguez, PhD (34913943837, jmrodrig@vet.ucm.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence of clinical mastitis confirmed by microbiological cultures and somatic cell counts (time frame: Weekly during the first 6 months after birth). 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 NCT01505361, which also lists 4 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 12 Jan 2012.