Evaluation of Lactobacillus Fermentum CECT5716 on the Incidence of Mastitis
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|ClinicalTrials.gov Identifier: NCT02203877|
Recruitment Status : Completed
First Posted : July 30, 2014
Last Update Posted : August 12, 2016
|Condition or disease||Intervention/treatment||Phase|
|Mastitis||Dietary Supplement: Lactobacillus fermentum CECT5716 Dietary Supplement: Maltodextrin||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||625 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Nutritional Intervention Study, Randomized, Double-blind, Parallel Group to Evaluate the Effect of Lactobacillus Fermentum CECT5716 Consumption on the Incidence of Mastitis|
|Study Start Date :||August 2013|
|Actual Primary Completion Date :||August 2015|
|Actual Study Completion Date :||August 2015|
Placebo Comparator: Maltodextrin
1 capsule/day for 16 weeks
Dietary Supplement: Maltodextrin
Intervention with a daily capsule containing maltodextrin as placebo
Experimental: Lactobacillus fermentum CECT5716
L.fermentum 3,00E+09cfu/day. 1 capsule/day for 16 weeks
Dietary Supplement: Lactobacillus fermentum CECT5716
Intervention with a probiotic strain in form of a daily capsule containing 3x109cfu/capsule.
- incidence of mastitis [ Time Frame: 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)
- evaluation of breast pain [ Time Frame: at times 0, 4, 8, 12 and 16 weeks ]For pain evaluation a score from 1 (no pain) to 10 (extremely pain)
- microbiota breast milk [ Time Frame: at time 0 and 16 weeks ]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.
- fecal microbiota of infants [ Time Frame: at 0 and 16 weeks ]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.
- growth of infants [ Time Frame: at 0 and 16 weeeks ]Weight, length and head circumference will be measured in infants at the beginning and at 16 weeks
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02203877
|Hospital Virgen de las Nieves|
|Study Chair:||Juristo Fonollá, PhD||Biosearch S.A.|