Study protocol: evaluation of the probiotic Lactobacillus Fermentum CECT5716 for the prevention of mastitis in breastfeeding women: a randomised controlled trial

Abstract

BackgroundMastitis and accompanying pain have been associated with the cessation of breastfeeding. Mastitis is an inflammatory condition of the breast and may be a result of decreased immunity and a lowered resistance to infection. Mastitis affects up to one in five breastfeeding women with most episodes occurring in the first 6–8 weeks postpartum. Antibiotics are often used in the treatment of mastitis, but have not been popular or proven effective as a preventative agent. The WHO has highlighted significant concerns relating to adverse harms of antibiotic use with the production of antibiotic-resistant strains of disease organisms. Increasing research suggests that specific probiotic bacteria possess significant anti-inflammatory properties and supports their potential use as immunomodulatory agents. While animal studies have shown promising results in the use of probiotics for preventing mastitis, their use in human trials has had limited investigation. The aim of this study is to evaluate the effectiveness of oral probiotics for the prevention of mastitis in breastfeeding women.MethodsAPProve (CAn Probiotics ImProve Breastfeeding Outcomes?) is a double-blind randomised controlled trial designed to assess outcomes between breastfeeding women ingesting a probiotic versus a placebo daily for 8 weeks following birth. A total of 600 women (300 to each arm) who intend to breastfeed will be randomised after the birth of a term, healthy infant. Daily and weekly surveys for 8 weeks and follow-up surveys at 2, 6 and 12 months after birth will assess the primary outcome of mastitis in the first 8 weeks following birth as well as secondary maternal outcomes of breastfeeding duration (total/partial), antibiotic use, maternal health and well-being, and treatment compliance; and infant outcomes including gastroenteritis, infant health and well-being and growth and development. The acceptability and compliance using a novel mobile phone application system will also be evaluated.DiscussionThere is an urgent need to explore safe and effective alternatives for preventing mastitis in breastfeeding women. This trial seeks to provide evidence for such an alternative in the form of probiotics, which may also increase breastfeeding duration, providing long-term health, cognitive and developmental benefits for children. Decreased antibiotic usage also benefits the community and health system.Trial registrationAustralian New Zealand Clinical Trials Registry: ACTRN12615000923561.Date of registration: 4th September, 2015, retrospectively registered.Electronic supplementary materialThe online version of this article (doi:10.1186/s12884-017-1330-8) contains supplementary material, which is available to authorized users.

Breast Milk, a Source of Beneficial Microbes and Associated Benefits for Infant Health

“…With regards to maternal health, studies have demonstrated that ingestion of human milk derived probiotic strains L. fermentum CECT5716 and L. salivarius CECT5713 resulted in significant reduction in Staphylococcus load, reduced breast pain, faster recovery, and lower reoccurrence rates of mastitis over lactation, thus suggesting an effective alternative to antibiotics for the treatment of mastitis during lactation [231,257,258]. Further investigations documented the use of L. fermentum CECT5716 as a preventative measure for mastitis [259], with positives results also being reported for the use of L. salivarius PS2 as a preventative measure for mastitis [260].…”

Comprehensive evaluation of the risk of lactational mastitis in Chinese women: combined logistic regression analysis with receiver operating characteristic curve

“…Antibiotics are often used in the treatment of mastitis, but have not been popular or proven effective as a preventative agent. Increasing research indicates that specific probiotic bacteria possess significant anti-inflammatory properties and supports their potential use as immunomodulatory agents [45]. Supplementation with lactobacilli and probiotics may eliminate the risk of mastitis in women and prevent breast infection.…”

Lactobacillus fermentum CECT5716 – prevention and treatment of lactational mastitis

“…опубликовали данные рандомизированного двойного слепого плацебо-контролируемого исследования по оценке эффективности приема Lactobacillus fermentum CECT5716 в течение 8 недель после родов кормящей женщиной [21]. Исследователи заключили, что использование данного пробиотического штамма лактобактерий увеличивает продолжительность грудного вскармливания, снижает необходимость в использовании антибактериальных препаратов, тем самым является безопасным и эффективным средством профилактики лактационного мастита [21]. Пациентки с наличием местной клинической симптоматики мастита отмечали значительное уменьшение болевых ощущений с первой недели приема препарата, содержащего Lactobacillus fermentum CECT5716 [17].…”