The effect of probiotics on glycemic control of women with gestational diabetes mellitus-multicenter, randomized, double blind, placebo controlled-trial

Abstract

Uncontrolled gestational diabetes mellitus (GDM) is associated with severe maternal and neonatal morbidities. Probiotic supplements were shown to modulate the gut microbiome. Promising effects on glycemic control and insulin resistance in non-pregnant diabetic patients were reported. However, the effect of probiotics on glycemic control in GDM has not been elucidated. We aimed to examine the effect of a mixture of probiotic strains given daily on maternal glycemic parameters, and pregnancy outcomes among women with GDM. A multicenter prospective randomized, double blind, placebo controlled trial was conducted at five medical centers between January 2020 and June 2021. Women newly diagnosed with GDM were divided into a research group, receiving 2 capsules of oral probiotic formula containing Bifidobacterium bifidum, Bifidobacterium lactis, Lactobacillus (L) acidophilus, L. paracasei, L. rhamnosus and Streptococcus thermophilus ( >6X109/capsule), and a control group, receiving a placebo (2 capsules/day) until delivery. Glycemic control was evaluated by daily glucose charts. After 2 weeks, pharmacotherapy was started in case of poor glycemic control defined as either mean daily glucose >100 mg/dL or more than 20% abnormal glucose values. The primary outcomes were the rate of women requiring medications for glycemic control and mean daily glucose charts after 2 weeks of treatment with the study products. In order to show a reduction of the need for pharmacotherapy for GDM from 60% to 30%, 84 women were required (5% two tailed alpha, 80% power). This sample size was sufficient to demonstrate a mean difference of 6±10 mg/dL in the mean daily glucose charts after 2 weeks of treatment with the study products. Forty one and 44 women were analyzed in the treatment and placebo cohorts, respectively. Baseline characteristics were comparable between the groups (table 1). There was no difference in glycemic control between the groups (table 2). The oral probiotic product tested in this study did not affect glycemic control of women with GDM.View Large Image Figure ViewerDownload Hi-res image Download (PPT)