Effect of the probiotic Lactobacillus reuteri on breast inflammation and lactational mastitis – a food supplement trial

Sahlgrenska University Hospital0 个研究点目标入组 52 人开始时间: 2016年4月5日最近更新: 2017年10月2日

适应症

试验速览

暂无简介。

•1. Women seeking help for breast inflammation and mastitis symptoms and who are counseled to home care without antibiotic treatment by health care professionals at the Department of obstetrics at Sahlgrenska University hospital. According to the hospital’s routine women are recommended home care without antibiotic treatment if other not-breast-related diagnosis have been excluded, if the woman’s general condition is stable and symptoms started no longer than 2-3 days before. Women with longer time since symptom debut will be offered a visit to the hospital. If the care giver after taking anamneses and examination decides that both general condition and local status allow home care without antibiotic treatment, the woman is still eligible for the study.
•2. Breast inflammation/Mastitis symptoms defined as fever start = 38°C before 4 hours or longer and at least 1 point for erythema and 1 point for breast tension on the Kvist-scale” according to the research midwife’s evaluation
•3. Age =18 years
•4. Capable of giving informed consent
•5. Willing to comply with treatment application
•6. Capable of understanding and complying with study protocol requirements
•7. That the baby is considered healthy according to the routine check ups
•8. Exclusive breastfeeding

•1. Judged by a health care professional to be in need of antibiotic treatment for her breast symptoms as described above
•2. Current breast injury, trauma, abscesses or other mammary pathology
•3. History of/current breast cancer
•4. Breast surgery in the past month
•5. New pregnancy
•6. Premature baby, born <37 weeks of gestational age
•7. Autoimmune disease (both mother and child)
•8. Known or suspected allergies to any of the components of the study product (both mother and child)
•9. Participation in another investigational drug study within 30 days prior to treatment start
•10. Use of any other probiotic (oral or local)
•11. Ongoing antibiotic treatment

发起方

Sahlgrenska University Hospital