L.Fermentum CECT5716 in Treatment of Breast Pain

Not Applicable

Completed

• Conditions: Breast Pain
• Interventions: Dietary Supplement: Lactobacillus fermentum CECT5716

• Registration Number: NCT02093338
• Lead Sponsor: Biosearch S.A.

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.

Study Timeline

• Study Start: 2011-07
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Study First Submitted: 2013-07-18
• Status Verified: 2014-03
• Study First Submitted QC: 2014-03-19
• Last Update Submitted: 2014-03-19
• Study First Posted: 2014-03-21
• Last Update Posted: 2014-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 127

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
fermentum 3x	Lactobacillus fermentum CECT5716	Lactobacillus fermentum CECT5716 at 3x10e9 cfu/day
fermentum 6x	Lactobacillus fermentum CECT5716	Lactobacillus fermentum CECT5716 at 6x10e9cfu/day
fermentum 9x	Lactobacillus fermentum CECT5716	Lactobacillus fermentum CECT5716 at 9x10e9cfu/day

Primary Outcome Measures

Name	Time	Method
Change from baseline Staphylococcus count at 3 weeks	0, 3 weeks	Counts of Staphylococcus in breast milk

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hospital Virgen de las Nieves; 🇪🇸 Granada, Spain