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

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

Study Overview

• Status: Completed
• Conditions: Breast Pain
• Intervention / Treatment: Dietary supplement: Lactobacillus fermentum CECT5716; Other: Placebo Comparator: maltodextrin

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.

• Study Type: Interventional
• Enrollment (Actual): 127
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Granada, Spain, 18012
    • Hospital Virgen de las Nieves

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: maltodextrin	Other: Placebo Comparator: maltodextrin; Placebo
Experimental: fermentum 3x; Lactobacillus fermentum CECT5716 at 3x10e9 cfu/day	Dietary supplement: Lactobacillus fermentum CECT5716
Experimental: fermentum 6x; Lactobacillus fermentum CECT5716 at 6x10e9cfu/day	Dietary supplement: Lactobacillus fermentum CECT5716
Experimental: fermentum 9x; Lactobacillus fermentum CECT5716 at 9x10e9cfu/day	Dietary supplement: Lactobacillus fermentum CECT5716

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Biosearch S.A.
• Collaborators: Funding: The Agency of Innovation and Development of Andalusia; Statistical analysis: SEPLIN Soluciones Estadísticas
• Investigators: Principal Investigator: Dr. Miguel A Díaz López, Doctor, Gynecology Service of Virgen de las Nieves Hospital, Granada (Spain)

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: July 18, 2013
• First Submitted That Met QC Criteria: March 19, 2014
• First Posted (Estimate): March 21, 2014

Study Record Updates

• Last Update Posted (Estimate): March 21, 2014
• Last Update Submitted That Met QC Criteria: March 19, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: probiotic; Staphylococcus; breast pain; mastitis; lactobacillus fermentun
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Mastodynia
• Other Study ID Numbers: P025