L.Fermentum CECT5716 in Treatment of Breast Pain

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02093338

Enrollment

127

Registered

2014-03-21

Start date

2011-07-31

Completion date

2013-04-30

Last updated

2014-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Pain

Keywords

breast pain, probiotic, mastitis, lactobacillus fermentun, Staphylococcus

Brief 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

Detailed description

1. 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) 2. 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. 3. 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. 4. 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. 5. Intervention duration The intervention will last three weeks.

Interventions

DIETARY_SUPPLEMENTLactobacillus fermentum CECT5716

OTHERPlacebo Comparator: maltodextrin

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

Inclusion criteria

· 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,

Exclusion criteria

* breast abscesses, Raynaud syndrome, * Antibiotic treatment * Allergic to antibiotics * Low expectation of compliance with the study protocol.

Design outcomes

Primary

Measure	Time frame	Description
Change from baseline Staphylococcus count at 3 weeks	0, 3 weeks	Counts of Staphylococcus in breast milk

Secondary

Measure	Time frame	Description
Change from baseline Streptococcus counts at 3 weeks	0, 3 weeks	Streptococcus counts in breast milk
Change from Breast pain score at 3 weeks	0, 3 weeks	evaluation of breast pain

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026