Clinical trial NCT02093338: L.Fermentum CECT5716 in Treatment of Breast Pain
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Pain
Keywords: breast pain
probiotic
mastitis
lactobacillus fermentun
Staphylococcus
Lead sponsor: Biosearch S.A.
Sponsor class: INDUSTRY
Collaborators: name: Junta de Andalucia
name: Statistical analysis: SEPLIN Soluciones Estadísticas
First posted: 2014-03-21
Enrollment: 127
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline Staphylococcus count at 3 weeks
timeFrame: 0, 3 weeks
Secondary outcomes:
measure: Change from baseline Streptococcus counts at 3 weeks
timeFrame: 0, 3 weeks
measure: Change from Breast pain score at 3 weeks
timeFrame: 0, 3 weeks
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Hospital Virgen de las Nieves
Study officials:
affiliation: Gynecology Service of Virgen de las Nieves Hospital, Granada (Spain)
name: Dr. Miguel A Díaz López, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.