MastitisNCT04032899
Effect of Probiotics Consumed During Pregnancy on the Incidence of Mastitis
A study testing Lactobacillus fermentum CECT5716 and Maltodextrin in people with Mastitis and Breast Milk, run by Biosearch S.A. at 3 sites in Spain.
Trial summary
The aim of the present study is to evaluate the effect of consumption during pregnancy and the lactation period of the probiotic L. fermentum CECT5716 on the incidence of 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, Breast Milk, Lactation
- 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
- 480 participants
- Where
- 3 sitesSpain
- Study dates
- 15 Apr 2019to 31 May 2024
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normal development of pregnancy
- Single fetus pregnancy
- Be in week 28-32 of pregnancy
- Intention to breastfeed the child for 16 weeks
Who cannot join
- Having a breast disease that hinders or prevents breastfeeding
- Have been taking probiotic supplements 2 weeks before starting the study
- Have a low expectation of adherence to the study protocol
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Hospital Campus de la Salud
Granada, Grabada, 18007
Hospital Virgen de las Nieves
Granada, Granada, 18014
Hospital Costa del Sol
Marbella, Andalusia, 29603
About this study
Official title: Multicenter, Randomized, Double-blind, Controlled Parallel Nutritional Intervention Study to Evaluate the Effect of Consumption During Pregnancy and the Lactation Period of Lactobacillus Fermentum CECT5716 on the Incidence of Mastitis
The aim of the present study is to evaluate the effect of consumption during pregnancy and the lactation period of the probiotic L. fermentum CECT5716 on the incidence of mastitis.
Bacterial load and immunological parameters in breast milk, parameters related to breastfeeding as well as health parameters of the mother and baby will also be evaluated.
Read the detailed description
Pregnancy and lactation are important moments for the child that will determine their development and future health. One of the key processes is when the microbiota is established in the baby. Contamination during delivery with the mother's vaginal flora, as well as bacteria from the microbiota of breast milk, are important sources for intestinal colonization. However, the mother's microbiota can suffer alterations that affect the health of the mother and can also have an effect on the baby.
Mastitis is a condition of the mammary gland that can affect between 3-30% of women during the period of lactation and is the first cause of abandonment of it. It is associated with a dysbiosis with the proliferation of microorganisms in milk such as Staphylococcus and Streptococcus.
Previous studies carried out with the strain L. fermentum CECT5716 have demonstrated a powerful regulating activity of the microbiota of breast milk that translates into a preventive and curative effect on mastitis. The highest incidence of mastitis occurs during the first weeks after delivery, so the investigator's working hypothesis is that the modulation of the maternal microbiota before delivery would improve the effectiveness of the probiotic strain consumption.
- Conditions
- Mastitis, Breast Milk, Lactation, Women's Health, Infant Health
- Being tested
- Lactobacillus fermentum CECT5716, Maltodextrin
- Keywords
- Probiotics, Gestation, Lactation, Mastitis
- Medical subject headings
- Mastitis, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus fermentum CECT5716Dietary supplement
Each participant will consume 1 capsule per day in one of the main meals without any restriction in the diet or in their life habits.
MaltodextrinDietary supplement
Each participant will consume 1 capsule per day in one of the main meals without any restriction in the diet or in their life habits.
| Study group | Role | What they receive |
|---|---|---|
| L. fermentum CECT5716 3x109 ufc | Experimental | Volunteers will take 1 capsule per day with L. fermentum CECT5716 3x109 cfu mixed with maltodextrin from week 28-32 of gestation up to 16 weeks after delivery. Receives: Dietary Supplement: Lactobacillus fermentum CECT5716 |
| Maltodextrin | Placebo comparator | Volunteers will take 1 capsule per day with maltodextrin from week 28-32 of gestation up to 16 weeks after delivery. Receives: Dietary Supplement: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of mastitis
Total events during breastfeeding period /total number of participants
Measured: 4 months
Secondary outcomes (1)
Microbiota of breast milk
Load of Staphylococcus, S. aureus, S. epidermidis, Streptococcus, Lactobacillus and L. fermentum CECT5716 in breast milk
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2019
- Study start15 Apr 2019
- Primary completion31 May 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- 480 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biosearch S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicolás Mendoza, MD, PhD, Principal investigator, Professor of Gynecology at the Faculty of Medicine of the University of Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04032899
- Sponsor's protocol ID
- P045
- Status last verified
- Feb 2025
- First submitted
- 27 May 2019
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- 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 32987448
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Double-blind, Controlled Parallel Nutritional Intervention Study to Evaluate the Effect of Consumption During Pregnancy and the Lactation Period of Lactobacillus Fermentum CECT5716 on the Incidence of Mastitis
- ClinicalTrials.gov ID
- NCT04032899
- Acronym / sponsor ID
- P045
- Conditions
- Mastitis, Breast Milk, Lactation, Women's Health, Infant Health
- Keywords
- Probiotics, Gestation, Lactation, Mastitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- Biosearch S.A.Industry (pharma, biotech, devices)
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 25 Jul 2019 (actual)
- 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.
The aim of the present study is to evaluate the effect of consumption during pregnancy and the lactation period of the probiotic L. fermentum CECT5716 on the incidence of mastitis.
Bacterial load and immunological parameters in breast milk, parameters related to breastfeeding as well as health parameters of the mother and baby will also be evaluated.
Detailed description
Pregnancy and lactation are important moments for the child that will determine their development and future health. One of the key processes is when the microbiota is established in the baby. Contamination during delivery with the mother's vaginal flora, as well as bacteria from the microbiota of breast milk, are important sources for intestinal colonization. However, the mother's microbiota can suffer alterations that affect the health of the mother and can also have an effect on the baby.
Mastitis is a condition of the mammary gland that can affect between 3-30% of women during the period of lactation and is the first cause of abandonment of it. It is associated with a dysbiosis with the proliferation of microorganisms in milk such as Staphylococcus and Streptococcus.
Previous studies carried out with the strain L. fermentum CECT5716 have demonstrated a powerful regulating activity of the microbiota of breast milk that translates into a preventive and curative effect on mastitis. The highest incidence of mastitis occurs during the first weeks after delivery, so the investigator's working hypothesis is that the modulation of the maternal microbiota before delivery would improve the effectiveness of the probiotic strain consumption.
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 |
|---|---|---|
| L. fermentum CECT5716 3x109 ufc | Experimental | Dietary Supplement: Lactobacillus fermentum CECT5716Volunteers will take 1 capsule per day with L. fermentum CECT5716 3x109 cfu mixed with maltodextrin from week 28-32 of gestation up to 16 weeks after delivery. |
| Maltodextrin | Placebo comparator | Dietary Supplement: MaltodextrinVolunteers will take 1 capsule per day with maltodextrin from week 28-32 of gestation up to 16 weeks after delivery. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Normal development of pregnancy
- Single fetus pregnancy
- Be in week 28-32 of pregnancy
- Intention to breastfeed the child for 16 weeks
Key exclusion criteria (3 listed)
- Having a breast disease that hinders or prevents breastfeeding
- Have been taking probiotic supplements 2 weeks before starting the study
- Have a 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 CECT5716Each participant will consume 1 capsule per day in one of the main meals without any restriction in the diet or in their life habits. | Dietary supplement | L. fermentum CECT5716 3x109 ufc |
| MaltodextrinEach participant will consume 1 capsule per day in one of the main meals without any restriction in the diet or in their life habits. | Dietary supplement | Maltodextrin |
Primary outcome
Incidence of mastitis
Time frame: 4 months
Total events during breastfeeding period /total number of participants
1 secondary outcome
Microbiota of breast milk
Time frame: 4 months
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 6 Feb 2025.
- 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.
- Individual participant dataSharing planned: No
Related trials for Mastitis
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Evaluation of Non-Surgical Treatment of Breast Abscess
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Not yet recruitingPhase 1/2
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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.
Nicolás Mendoza, MD, PhD principal investigator
Professor of Gynecology at the Faculty of Medicine of the University of Granada
3 sites 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 and Breast Milk, run by Biosearch S.A. at 3 sites 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 3 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 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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: 4 months). 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 NCT04032899, which also lists 1 linked publication.
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 6 Feb 2025.