L.Fermentum CECT5716 in Treatment of Breast Pain

Breast Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02093338
• Other study ID #: P025
• Status: Completed
• Phase: N/A
• First received: July 18, 2013
• Last updated: March 19, 2014
• Start date: July 2011
• Est. completion date: April 2013

Study information

• Verified date: March 2014
• Source: Biosearch S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Pain
• Mastodynia

Intervention

Dietary Supplement:
• Lactobacillus fermentum CECT5716

Other:
• Placebo Comparator: maltodextrin
Placebo

Locations

Country	Name	City	State
Spain	Hospital Virgen de las Nieves	Granada

Sponsors (3)

Lead Sponsor	Collaborator
Biosearch S.A.	Funding: The Agency of Innovation and Development of Andalusia, Statistical analysis: SEPLIN Soluciones Estadísticas

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline Staphylococcus count at 3 weeks	Counts of Staphylococcus in breast milk	0, 3 weeks	No
Secondary	Change from baseline Streptococcus counts at 3 weeks	Streptococcus counts in breast milk	0, 3 weeks	No
Secondary	Change from Breast pain score at 3 weeks	evaluation of breast pain	0, 3 weeks	No