Evaluation of Lactobacillus Fermentum CECT5716 on the Incidence of Mastitis

Not Applicable

Completed

• Conditions: Mastitis
• Interventions: Dietary Supplement: Maltodextrin; Dietary Supplement: Lactobacillus fermentum CECT5716

• Registration Number: NCT02203877
• Lead Sponsor: Biosearch S.A.

Brief Summary

To evaluate the effect of the consumption of Lactobacillus fermentum CECT5716 on mastitis incidence.

Detailed Description

Previous studies have demonstrated that L. fermentum CECT5716, a probiotic strain previously isolated from breast milk, can be used as an effective treatment of mastitis and painful breastfeeding by reducing pathogen counts in breast milk. This is a randomized double blinded controlled study to evaluate the effect of L.fermentum CECT5716 on mastitis incidence and Staphylococcus load in breast milk. Women will be recruited 1-6 days after child birth and distributed into two groups: Probiotic group receiving 1 capsule/day containing L.fermentum 3x109cfu; Control group receiving 1 placebo capsule/day containing maltodextrin. The intervention period is 16 weeks.

Study Timeline

• Study Start: 2013-08
• Status Verified: 2014-07
• Study First Submitted: 2014-07-29
• Study First Submitted QC: 2014-07-29
• Study First Posted: 2014-07-30
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Last Update Submitted: 2016-08-11
• Last Update Posted: 2016-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 625

Inclusion Criteria

• Healthy women between 18 and 40 years with development of normal pregnancy Birth between 37 and 42 weeks of gestation. Women who have received antibiotic treatment between 48 hours before and 48 hours after childbirth (one dose is sufficient for inclusion regardless of the type of antibiotic).

Childbirth took place 1-7 days prior to recruitment.. With firm intention to breast-feed their children for at least 16 weeks..

Exclusion Criteria

• • Mammary pathologies that hinder or preclude breastfeeding.
• Low expectation of adherence to the study protocol.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Maltodextrin	Maltodextrin	1 capsule/day for 16 weeks
Lactobacillus fermentum CECT5716	Lactobacillus fermentum CECT5716	L.fermentum 3,00E+09cfu/day. 1 capsule/day for 16 weeks

Primary Outcome Measures

Name	Time	Method
incidence of mastitis	up to 16 weeks	mastitis was defined as at least two out of the three breast symptoms (pain, redness, lump) and at least one of fever or flu-like symptoms (shivering, hot sweats or aches)

Secondary Outcome Measures

Name	Time	Method
evaluation of breast pain	at times 0, 4, 8, 12 and 16 weeks	For pain evaluation a score from 1 (no pain) to 10 (extremely pain)

Trial Locations

Locations (1)

Hospital Virgen de las Nieves; 🇪🇸 Granada, Spain