MastitisNCT02203877
Evaluation of Lactobacillus Fermentum CECT5716 on the Incidence of Mastitis
A study testing Lactobacillus fermentum CECT5716 and Maltodextrin in people with Mastitis, run by Biosearch S.A. at 1 site in Spain.
Trial summary
To evaluate the effect of the consumption of Lactobacillus fermentum CECT5716 on mastitis incidence. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mastitis
- What is being tested?
- Lactobacillus fermentum CECT5716 and Maltodextrin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 625 participants
- Where
- 1 siteSpain
- Study dates
- Aug 2013to Aug 2015
- Phase
- Interventional
- 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy women between 18 and 40 years with development of normal pregnancy Birth between 37 and 42 weeks of gestation. Women who have received antibiotic treatment between 48 hours before and 48 hours after childbirth (one dose is sufficient for inclusion regardless of the type of antibiotic).
- Childbirth took place 1-7 days prior to recruitment.. With firm intention to breast-feed their children for at least 16 weeks..
Who cannot join
- - Mammary pathologies that hinder or preclude breastfeeding.
- Low expectation of adherence to the study protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nutritional Intervention Study, Randomized, Double-blind, Parallel Group to Evaluate the Effect of Lactobacillus Fermentum CECT5716 Consumption on the Incidence of Mastitis
To evaluate the effect of the consumption of Lactobacillus fermentum CECT5716 on mastitis incidence.
Read the detailed description
Previous studies have demonstrated that L. fermentum CECT5716, a probiotic strain previously isolated from breast milk, can be used as an effective treatment of mastitis and painful breastfeeding by reducing pathogen counts in breast milk. This is a randomized double blinded controlled study to evaluate the effect of L.fermentum CECT5716 on mastitis incidence and Staphylococcus load in breast milk. Women will be recruited 1-6 days after child birth and distributed into two groups: Probiotic group receiving 1 capsule/day containing L.fermentum 3x109cfu; Control group receiving 1 placebo capsule/day containing maltodextrin. The intervention period is 16 weeks.
- Conditions
- Mastitis
- Being tested
- Lactobacillus fermentum CECT5716, Maltodextrin
- Medical subject headings
- Mastitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus fermentum CECT5716Dietary supplement
Intervention with a probiotic strain in form of a daily capsule containing 3x109cfu/capsule.
MaltodextrinDietary supplement
Intervention with a daily capsule containing maltodextrin as placebo
| Study group | Role | What they receive |
|---|---|---|
| Maltodextrin | Placebo comparator | 1 capsule/day for 16 weeks Receives: Dietary Supplement: Maltodextrin |
| Lactobacillus fermentum CECT5716 | Experimental | L.fermentum 3,00E+09cfu/day. 1 capsule/day for 16 weeks Receives: Dietary Supplement: Lactobacillus fermentum CECT5716 |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of mastitis
mastitis was defined as at least two out of the three breast symptoms (pain, redness, lump) and at least one of fever or flu-like symptoms (shivering, hot sweats or aches)
Measured: up to 16 weeks
Secondary outcomes (1)
evaluation of breast pain
For pain evaluation a score from 1 (no pain) to 10 (extremely pain)
Measured: at times 0, 4, 8, 12 and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2014 (estimated)
- Study startAug 2013
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MastitisStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 625 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biosearch S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Juristo Fonollá, PhD, Study chair, Biosearch S.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02203877
- Sponsor's protocol ID
- P032
- Status last verified
- Jul 2014
- First submitted
- 29 Jul 2014
- Last updated
- 12 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Crepinsek 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 32987448Pastor-Villaescusa B, Hurtado JA, Gil-Campos M, Uberos J, Maldonado-Lobon JA, Diaz-Ropero MP, Banuelos O, Fonolla J, Olivares M; PROLAC Group. Effects of Lactobacillus fermentum CECT5716 Lc40 on infant growth and health: a randomised clinical trial in nursing women. Benef Microbes. 2020 May 11;11(3):235-244. doi: 10.3920/BM2019.0180. Epub 2020 Mar 27.
PubMed 32216468
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Intervention Study, Randomized, Double-blind, Parallel Group to Evaluate the Effect of Lactobacillus Fermentum CECT5716 Consumption on the Incidence of Mastitis
- ClinicalTrials.gov ID
- NCT02203877
- Acronym / sponsor ID
- P032
- Conditions
- Mastitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 625 participants (actual)
- Lead sponsor
- Biosearch S.A.Industry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 30 Jul 2014 (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.
To evaluate the effect of the consumption of Lactobacillus fermentum CECT5716 on mastitis incidence.
Detailed description
Previous studies have demonstrated that L. fermentum CECT5716, a probiotic strain previously isolated from breast milk, can be used as an effective treatment of mastitis and painful breastfeeding by reducing pathogen counts in breast milk. This is a randomized double blinded controlled study to evaluate the effect of L.fermentum CECT5716 on mastitis incidence and Staphylococcus load in breast milk. Women will be recruited 1-6 days after child birth and distributed into two groups: Probiotic group receiving 1 capsule/day containing L.fermentum 3x109cfu; Control group receiving 1 placebo capsule/day containing maltodextrin. The intervention period is 16 weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maltodextrin | Placebo comparator | Dietary Supplement: Maltodextrin1 capsule/day for 16 weeks |
| Lactobacillus fermentum CECT5716 | Experimental | Dietary Supplement: Lactobacillus fermentum CECT5716L.fermentum 3,00E+09cfu/day. 1 capsule/day for 16 weeks |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy women between 18 and 40 years with development of normal pregnancy Birth between 37 and 42 weeks of gestation. Women who have received antibiotic treatment between 48 hours before and 48 hours after childbirth (one dose is sufficient for inclusion regardless of the type of antibiotic).
- Childbirth took place 1-7 days prior to recruitment.. With firm intention to breast-feed their children for at least 16 weeks..
Key exclusion criteria (2 listed)
- - Mammary pathologies that hinder or preclude breastfeeding.
- Low expectation of adherence to the study protocol.
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 fermentum CECT5716Intervention with a probiotic strain in form of a daily capsule containing 3x109cfu/capsule. | Dietary supplement | Lactobacillus fermentum CECT5716 |
| MaltodextrinIntervention with a daily capsule containing maltodextrin as placebo | Dietary supplement | Maltodextrin |
Primary outcome
incidence of mastitis
Time frame: up to 16 weeks
mastitis was defined as at least two out of the three breast symptoms (pain, redness, lump) and at least one of fever or flu-like symptoms (shivering, hot sweats or aches)
1 secondary outcome
evaluation of breast pain
Time frame: at times 0, 4, 8, 12 and 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2016.
- 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 32216468Pastor-Villaescusa B, Hurtado JA, Gil-Campos M, Uberos J, Maldonado-Lobon JA, Diaz-Ropero MP, Banuelos O, Fonolla J, Olivares M; PROLAC Group. Effects of Lactobacillus fermentum CECT5716 Lc40 on infant growth and health: a randomised clinical trial in nursing women. Benef Microbes. 2020 May 11;11(3):235-244. doi: 10.3920/BM2019.0180. Epub 2020 Mar 27.
- Individual participant dataSharing planned: No
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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.
Juristo Fonollá, PhD study chair
Biosearch S.A.
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 fermentum CECT5716 and Maltodextrin in people with Mastitis, run by Biosearch S.A. 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 2 inclusion and 2 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 12 Aug 2016. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
incidence of mastitis (time frame: up to 16 weeks). 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 NCT02203877, which also lists 2 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 Aug 2016.