Enav Yefet, Department of Obstetrics and Gynecology, Tzafon Medical Center, Poriya, Israel, and colleagues aimed to examine the effect of a mixture of probiotic strains on maternal glycemic parameters, particularly pregnancy outcomes and pre-prandial and postprandial glucose values among women with gestational diabetes in a multicenter, randomized, double-blind, placebo-controlled trial.
They found that the oral probiotic product tested in this study did not affect the glycemic control of women with GDM. They reported that compared with placebo, probiotics did not improve glycemic control and did not reduce the need for pharmacotherapy for glycemic control following two weeks of treatment and throughout the study.
The researchers noted that gestational diabetes mellitus should be treated adequately to avoid maternal hyperglycemia-related complications. Previously, probiotic supplements were indicated to improve fasting blood glucose in women with GDM. However, a major limitation of previous studies was that pre-prandial and especially post-prandial glucose values, which are important predictors of pregnancy outcomes, were not studied.
The research conducted a multicenter prospective randomized, double-blind, placebo-controlled trial including women newly diagnosed with GDM. They were randomly allocated into a research group, receiving two capsules of oral probiotic formula containing Bifidobacterium bifidum, Bifidobacterium lactis, Lactobacillus (L) acidophilus, L. rhamnosus, L. paracasei, and Streptococcus thermophilus (>6 × 109/capsule), and a control group, receiving a placebo (two capsules/day) until delivery.
Daily glucose charts were used to evaluate glycemic control. Pharmacotherapy was started after two weeks in case of poor glycemic control. The primary outcomes were determined as the rate of women requiring medications for glycemic control and mean daily glucose charts after two weeks of treatment with the study products. Forty-one and 44 women were evaluated in the treatment and placebo cohorts, respectively.
The study led to the following findings:
- During the first two weeks, mean daily glucose in the probiotics and placebo groups was 99.7±7.9 and 98.0±9.3 mg/dL, respectively.
- The rate of women needing pharmacotherapy due to poor glycemic control after two weeks of treatment in the probiotics and placebo groups was 59% and 41%, respectively.
- Mean, pre-prandial and post-prandial glucose levels throughout the study period were similar between the groups.
- There were no differences in maternal and neonatal outcomes including birth weight and adverse effect profile between the groups.
"The oral probiotic product tested in this study has no impact on glycemic control of women with gestational diabetes," the researchers concluded.
Nachum Z, Perlitz Y, Shavit LY, Magril G, Vitner D, Zipori Y, Weiner E, Alon AS, Ganor-Paz Y, Nezer M, Harel N, Soltsman S, Yefet E. The effect of oral probiotics on glycemic control of women with gestational diabetes mellitus - multicenter, randomized, double blind, placebo controlled trial. Am J Obstet Gynecol MFM. 2023 Nov 11:101224. doi: 10.1016/j.ajogmf.2023.101224. Epub ahead of print. PMID: 37956906.