An interventional study of Lactobacillus fermentum CECT5716 and Maltodextrin in Mastitis, sponsored by Biosearch S.A.. Completed at 1 site in Spain. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-08-12.
Sponsored by Biosearch S.A. (part of Kerry Group plc) · Not applicable, Interventional, and Prevention
To evaluate the effect of the consumption of Lactobacillus fermentum CECT5716 on mastitis incidence.
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.
31 studies on the registry are indexed under Mastitis; 7 are open to participants now.
This study's enrollment of 625 is above the median of 114 across 16 interventional studies indexed under Mastitis.
Browse Mastitis studies →Biosearch S.A. is the lead sponsor of 23 studies on the registry; none are open to participants now.
First submitted before Biosearch S.A. became part of Kerry Group plc.
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Childbirth took place 1-7 days prior to recruitment.. With firm intention to breast-feed their children for at least 16 weeks..
Exclusion Criteria:
1 capsule/day for 16 weeks
Dietary Supplement: Maltodextrin
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.
Intervention with a daily capsule containing maltodextrin as placebo
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)
Time frame: up to 16 weeks
evaluation of breast pain
For pain evaluation a score from 1 (no pain) to 10 (extremely pain)
Time frame: at times 0, 4, 8, 12 and 16 weeks
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.
Time frame: at time 0 and 16 weeks
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.
Time frame: at 0 and 16 weeks
growth of infants
Weight, length and head circumference will be measured in infants at the beginning and at 16 weeks
Time frame: at 0 and 16 weeeks
Plan to share: No
This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.
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