Oral Lactobacillus fermentum CECT5716 in the patients with lactational abscess treated by needle aspiration: The late follow-up of a randomized controlled trial

Abstract

Background: Lactational mastitis and breast abscess cause trouble for women. It has been shown that oral probiotics can improve breast microecology, thus alleviating inflammatory responses. Our study aims to understand the long-term effect of Lactobacillus fermentum CECT5716 on patients with lactational breast abscess after needle aspiration. Methods: Data continued in a randomized controlled study of 101 subjects with lactational abscess from 12 hospitals were included. They were randomly divided into an experimental group and a control group. After needle aspiration treatment, the experimental group was orally administrated with L fermentum CECT5716 for 4 consecutive weeks, while the control group was treated with maltodextrin in the same way). In the third month after randomized controlled trial, the subjects were followed up by an online questionnaire investigation. The observation indexes included the relief of breast pain, recurrence of mastitis from the end of oral administration to the follow-up, and the effect on continuing breastfeeding. Results: A total of 101 patients were enrolled and 83 valid questionnaires were received during follow-up, including 40 in the experimental group and 43 in the control group. The rate of stop breastfeeding due to recurrence of mastitis was 2.5% (1/40) in the experimental group and 18.6% (8/43) in the control group, with a statistically significant difference (odds ratio = 0.112, 95% confidence interval: 0.013-0.942, P