Breast PainNCT02093338
L.Fermentum CECT5716 in Treatment of Breast Pain
A study testing Lactobacillus fermentum CECT5716 in people with Breast Pain, run by Biosearch S.A. at 1 site in Spain.
Trial summary
The main objective of this intervention study is to evaluate the efficacy of Lactobacillus fermentum CECT5716 to reduce the presence in the milk of genera Staphylococcus and Streptococcus as risk factors for mastitis in women with breast pain Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Breast Pain
- What is being tested?
- Lactobacillus fermentum CECT5716
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 127 participants
- Where
- 1 siteSpain
- Study dates
- Jul 2011to Apr 2013
- 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
- No healthy volunteers
- Adult
Who may be able to join
- breast-feeding women
- Swelling and / or warmth in the chest
- Chest pain
- total bacteria count in milk greater than or equal to 3 log10 colony forming units (CFU) / mL,
Who cannot join
- breast abscesses, Raynaud syndrome,
- Antibiotic treatment
- Allergic to antibiotics
- Low expectation of compliance with the study protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Intervention Nutritional, Multicenter, Randomized, Blind, Parallel Group to Evaluate the Efficacy of Lactobacillus Fermentum CECT5716 to Reduce the Load Bacterial in Potential Pathogens in Milk of Mothers With Breast Pain
The main objective of this intervention study is to evaluate the efficacy of Lactobacillus fermentum CECT5716 to reduce the presence in the milk of genera Staphylococcus and Streptococcus as risk factors for mastitis in women with breast pain
Read the detailed description
- Type of study Nutritional intervention study, multicenter, randomized, blinded, parallel group included 25 women per group
- Group 1: 3x109 cfu / day (n = 25)
- Group 2: 6x109 cfu / day (n = 25)
- Group 3: 9x109 cfu / day (n = 25)
- Group 4: placebo (n = 25)
- Statistical calculation of sample size. The calculation of sample size was calculated by the company SEPLIN Solutions Statistics. The primary endpoint was the bacterial count of in milk. The sample size obtained to observe a difference of 1 log10, with a power of 0.80 and a significance level of 0.05 was 20 volunteers per group.
- Randomization Randomization was performed using a list of random numbers generated by computer. Subjects will be randomized in a strictly sequential. If a subject is removed from the test, the number that was assigned randomization not be reused again.
- Overall design and outline of the study At visit 1 we require the informed consent of the patient. It will take the milk sample, we will review the implementation of the inclusion and exclusion criteria. Be randomized and explain the treatment guidelines to be followed, the data to be collected and medical appointments that must go (2 and 3 weeks). It will complete the pain assessment questionnaire (MQP) and nutrition survey. On visits 2, 3 and 4 corresponding to 1, 2 and 3 weeks of intervention will collect milk sample pain assessment survey and nutrition survey. Milk samples (5 mL) were collected aseptically in sterile tubes to be frozen immediately until analysis to be carried out within seven days.
- Intervention duration The intervention will last three weeks.
- Conditions
- Breast Pain
- Being tested
- Lactobacillus fermentum CECT5716, Placebo Comparator: maltodextrin
- Keywords
- breast pain, probiotic, mastitis, lactobacillus fermentun, Staphylococcus
- Medical subject headings
- Mastodynia, Mastitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus fermentum CECT5716Dietary supplement
Placebo Comparator: maltodextrinOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| fermentum 3x | Experimental | Lactobacillus fermentum CECT5716 at 3x10e9 cfu/day Receives: Dietary Supplement: Lactobacillus fermentum CECT5716 |
| fermentum 6x | Experimental | Lactobacillus fermentum CECT5716 at 6x10e9cfu/day Receives: Dietary Supplement: Lactobacillus fermentum CECT5716 |
| fermentum 9x | Experimental | Lactobacillus fermentum CECT5716 at 9x10e9cfu/day Receives: Dietary Supplement: Lactobacillus fermentum CECT5716 |
| maltodextrin | Placebo comparator | maltodextrin Receives: Other: Placebo Comparator: maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Staphylococcus count at 3 weeks
Counts of Staphylococcus in breast milk
Measured: 0, 3 weeks
Secondary outcomes (2)
Change from baseline Streptococcus counts at 3 weeks
Streptococcus counts in breast milk
Measured: 0, 3 weeks
Change from Breast pain score at 3 weeks
evaluation of breast pain
Measured: 0, 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2014 (estimated)
- Study startJul 2011
- Primary completionApr 2013
- Study completionApr 2013
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 Breast PainStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biosearch S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Junta de Andalucia, Statistical analysis: SEPLIN Soluciones Estadísticas
- Responsible party
- Sponsor
- Investigators
- Dr. Miguel A Díaz López, Doctor, Principal investigator, Gynecology Service of Virgen de las Nieves Hospital, Granada (Spain)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02093338
- Sponsor's protocol ID
- P025
- Status last verified
- Mar 2014
- First submitted
- 18 Jul 2013
- Last updated
- 21 Mar 2014
- Results posted
- No
- Data monitoring committee
- 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 21 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Intervention Nutritional, Multicenter, Randomized, Blind, Parallel Group to Evaluate the Efficacy of Lactobacillus Fermentum CECT5716 to Reduce the Load Bacterial in Potential Pathogens in Milk of Mothers With Breast Pain
- ClinicalTrials.gov ID
- NCT02093338
- Acronym / sponsor ID
- P025
- Conditions
- Breast Pain
- Keywords
- breast pain, probiotic, mastitis, lactobacillus fermentun, Staphylococcus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Biosearch S.A.Industry (pharma, biotech, devices)
- Collaborators
- Junta de Andalucia, Statistical analysis: SEPLIN Soluciones Estadísticas
- Study start
- Jul 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 21 Mar 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.
The main objective of this intervention study is to evaluate the efficacy of Lactobacillus fermentum CECT5716 to reduce the presence in the milk of genera Staphylococcus and Streptococcus as risk factors for mastitis in women with breast pain
Detailed description
- Type of study Nutritional intervention study, multicenter, randomized, blinded, parallel group included 25 women per group
- Group 1: 3x109 cfu / day (n = 25)
- Group 2: 6x109 cfu / day (n = 25)
- Group 3: 9x109 cfu / day (n = 25)
- Group 4: placebo (n = 25)
- Statistical calculation of sample size. The calculation of sample size was calculated by the company SEPLIN Solutions Statistics. The primary endpoint was the bacterial count of in milk. The sample size obtained to observe a difference of 1 log10, with a power of 0.80 and a significance level of 0.05 was 20 volunteers per group.
- Randomization Randomization was performed using a list of random numbers generated by computer. Subjects will be randomized in a strictly sequential. If a subject is removed from the test, the number that was assigned randomization not be reused again.
- Overall design and outline of the study At visit 1 we require the informed consent of the patient. It will take the milk sample, we will review the implementation of the inclusion and exclusion criteria. Be randomized and explain the treatment guidelines to be followed, the data to be collected and medical appointments that must go (2 and 3 weeks). It will complete the pain assessment questionnaire (MQP) and nutrition survey. On visits 2, 3 and 4 corresponding to 1, 2 and 3 weeks of intervention will collect milk sample pain assessment survey and nutrition survey. Milk samples (5 mL) were collected aseptically in sterile tubes to be frozen immediately until analysis to be carried out within seven days.
- Intervention duration The intervention will last three weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| fermentum 3x | Experimental | Dietary Supplement: Lactobacillus fermentum CECT5716Lactobacillus fermentum CECT5716 at 3x10e9 cfu/day |
| fermentum 6x | Experimental | Dietary Supplement: Lactobacillus fermentum CECT5716Lactobacillus fermentum CECT5716 at 6x10e9cfu/day |
| fermentum 9x | Experimental | Dietary Supplement: Lactobacillus fermentum CECT5716Lactobacillus fermentum CECT5716 at 9x10e9cfu/day |
| maltodextrin | Placebo comparator | Other: Placebo Comparator: maltodextrinmaltodextrin |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- breast-feeding women
- Swelling and / or warmth in the chest
- Chest pain
- total bacteria count in milk greater than or equal to 3 log10 colony forming units (CFU) / mL,
Key exclusion criteria (4 listed)
- breast abscesses, Raynaud syndrome,
- Antibiotic treatment
- Allergic to antibiotics
- Low expectation of compliance with 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 CECT5716 | Dietary supplement | fermentum 3x, fermentum 6x, fermentum 9x |
| Placebo Comparator: maltodextrinPlacebo | Other | maltodextrin |
Primary outcome
Change from baseline Staphylococcus count at 3 weeks
Time frame: 0, 3 weeks
Counts of Staphylococcus in breast milk
2 secondary outcomes
Change from baseline Streptococcus counts at 3 weeks
Time frame: 0, 3 weeks
Change from Breast pain score at 3 weeks
Time frame: 0, 3 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 21 Mar 2014.
- 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.
Related trials for Breast Pain
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Not yet recruiting
Comparison of Serratus Posterior Superior Intercostal Plane Block and Rhomboid Intercostal Block in Patients Undergoing Breast Cancer Surgery
Breast Cancer, Lymph Node Dissection
Not yet recruitingPhase 4
Evaluation of the Efficacy and Acceptability of a Phytotherapy Combining Devil's Claw, Blackcurrant and Meadowsweet for the Management of Aromatase Inhibitor-induced Arthralgia in Patients Treated for Localized Breast Cancer in the Adjuvant Setting
Hormone Therapy-induced Arthralgia, Phytotherapy
Not yet recruiting
Effect of Adding Ultrasound-Guided PECS II Block to Standard Multimodal Analgesia in Breast Augmentation Surgery
Postoperative Pain After Breast Augmentation Surgery, Postoperative Analgesia
Not yet recruiting
The Effect of Music Play and Stress Ball Application on Placental Separation Time, Episious Pain and Breastfeeding Success
Primiparity (First-Time Mothers), Breastfeeding
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.
Dr. Miguel A Díaz López, Doctor principal investigator
Gynecology Service of Virgen de las Nieves Hospital, Granada (Spain)
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 in people with Breast Pain, 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 4 inclusion and 4 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 21 Mar 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. 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?
Change from baseline Staphylococcus count at 3 weeks (time frame: 0, 3 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 NCT02093338, 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 21 Mar 2014.