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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Maltodextrin | Placebo Comparator | 1 capsule/day for 16 weeks |
|
| Lactobacillus fermentum CECT5716 | Experimental | L.fermentum 3,00E+09cfu/day. 1 capsule/day for 16 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus fermentum CECT5716 | Dietary Supplement | Intervention with a probiotic strain in form of a daily capsule containing 3x109cfu/capsule. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| fecal microbiota of infants |
Inclusion Criteria:
Childbirth took place 1-7 days prior to recruitment.. With firm intention to breast-feed their children for at least 16 weeks..
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juristo FonollĆ”, PhD | Biosearch S.A. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Virgen de las Nieves | Granada | Granada | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32987448 | Derived | Crepinsek MA, Taylor EA, Michener K, Stewart F. Interventions for preventing mastitis after childbirth. Cochrane Database Syst Rev. 2020 Sep 29;9(9):CD007239. doi: 10.1002/14651858.CD007239.pub4. | |
| 32216468 | Derived | Pastor-Villaescusa B, Hurtado JA, Gil-Campos M, Uberos J, Maldonado-Lobon JA, Diaz-Ropero MP, Banuelos O, Fonolla J, Olivares M; PROLAC Group. Effects of Lactobacillus fermentum CECT5716 Lc40 on infant growth and health: a randomised clinical trial in nursing women. Benef Microbes. 2020 May 11;11(3):235-244. doi: 10.3920/BM2019.0180. Epub 2020 Mar 27. |
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| ID | Term |
|---|---|
| D008413 | Mastitis |
| ID | Term |
|---|---|
| D011644 | Puerperal Disorders |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| C008315 | maltodextrin |
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| Maltodextrin | Dietary Supplement | Intervention with a daily capsule containing maltodextrin as placebo |
|
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 |
| 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 |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |