Evaluation of Lactobacillus Fermentum CECT5716 on the Incidence of Mastitis

Mastitis Clinical Trial

Official title:

Nutritional Intervention Study, Randomized, Double-blind, Parallel Group to Evaluate the Effect of Lactobacillus Fermentum CECT5716 Consumption on the Incidence of Mastitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02203877
• Other study ID #: P032
• Status: Completed
• Phase: N/A
• First received: July 29, 2014
• Last updated: August 11, 2016
• Start date: August 2013
• Est. completion date: August 2015

Study information

• Verified date: July 2014
• Source: Biosearch S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 625
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Mastitis

Intervention

Dietary Supplement:
• Lactobacillus fermentum CECT5716
Intervention with a probiotic strain in form of a daily capsule containing 3x109cfu/capsule.
• Maltodextrin
Intervention with a daily capsule containing maltodextrin as placebo

Locations

Country	Name	City	State
Spain	Hospital Virgen de las Nieves	Granada

Sponsors (1)

Lead Sponsor	Collaborator
Biosearch S.A.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	microbiota breast milk	DNA will be extracted from breast milk samples. Staphylococcus genus, Streptococcus and Lactobacillus will be evaluated by qPCR with specific probes designed to quantify these bacterial genus.	at time 0 and 16 weeks	No
Other	fecal microbiota of infants	DNA will be extracted from infant´s feces samples. Lactobacillus, bifidobacterium, clostridium, bacteroides will be evaluated by qPCR with specific probes designed to quantify these bacterial genus.	at 0 and 16 weeks	No
Other	growth of infants	Weight, length and head circumference will be measured in infants at the beginning and at 16 weeks	at 0 and 16 weeeks	No
Primary	incidence of mastitis	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)	up to 16 weeks	No
Secondary	evaluation of breast pain	For pain evaluation a score from 1 (no pain) to 10 (extremely pain)	at times 0, 4, 8, 12 and 16 weeks	No