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

BACKGROUND: Gestational diabetes mellitus (GDM) should be treated adequately in order to avoid maternal hyperglycemia-related complications. Previously, probiotic supplements were suggested to improve fasting blood glucose in women with GDM. Yet, 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.

OBJECTIVE: To examine the effect of a mixture of probiotic strains on maternal glycemic parameters, particularly pre-prandial and postprandial glucose values and pregnancy outcomes among women with GDM.

STUDY DESIGN: A multicenter prospective randomized, double blind, placebo controlled trial was conducted. Women newly diagnosed with GDM were randomly allocated into a research group, receiving two capsules of oral probiotic formula containing Bifidobacterium bifidum, Bifidobacterium lactis, Lactobacillus (L) acidophilus, L. paracasei, L. rhamnosus and Streptococcus thermophilus (>6 × 109 /capsule), and a control group, receiving a placebo (two capsules/day) until delivery. Glycemic control was evaluated by daily glucose charts. After two weeks, pharmacotherapy was started in case of poor glycemic control. The primary outcomes were the rate of women requiring medications for glycemic control and mean daily glucose charts after two weeks of treatment with the study products.

RESULTS: Forty one and 44 women were analyzed in the treatment and placebo cohorts, respectively. Mean daily glucose during the first two weeks in the probiotics and placebo groups was 99.7±7.9 and 98.0±9.3 mg/dL, respectively; P=0.35. The rate of women needing pharmacotherapy due to poor glycemic control after two weeks of treatment in the probiotics and placebo groups was 24 (59%) and 18 (41%), respectively; P=0.10. Mean, pre-prandial and post-prandial glucose levels throughout the study period were similar between the groups (P>0.05). There were no differences in maternal and neonatal outcomes including birth weight and adverse effect profile between the groups.

CONCLUSION: The oral probiotic product tested in this study did not affect glycemic control of women with GDM.