The Effects of Synbiotic Supplementation on Pregnancy Outcomes in Gestational Diabetes (Publication with Expression of Concern)

Synbiotics are known to exert multiple beneficial effects, including anti-inflammatory and antioxidative actions. This study was designed to evaluate the effects of synbiotic administration on biomarkers of inflammation, oxidative stress, and pregnancy outcomes among gestational diabetic (GDM) women. This randomized, double-blind, placebo-controlled clinical trial was carried out among 60 subjects with GDM who were not on oral hypoglycemic agents. Patients were randomly assigned to consume either one synbiotic capsule containing Lactobacillus acidophilus strain T16 (IBRCM10785), L. casei strain T2 (IBRC-M10783), and Bifidobacterium bifidum strain T16 (IBRC-M10771) (2 x 10(9) CFU/g each) plus 800 mg inulin (HPX) (n = 30) or placebo (n = 30) for 6 weeks. Compared with the placebo, synbiotic supplementation significantly decreased serum high-sensitivity C-reactive protein (hs-CRP) (- 1.9 +/- 4.2 vs. + 1.1 +/- 3.5 mg/L, P = 0.004), plasma malondialdehyde (MDA) (- 0.1 +/- 0.6 vs. + 0.3 +/- 0.7 mu mol/L, P = 0.02), and significantly increased total antioxidant capacity (TAC) (+ 70.1 +/- 130.9 vs. - 19.7 +/- 124.6 mmol/L, P = 0.009) and total glutathione (GSH) levels (+ 28.7 +/- 61.5 vs. - 14.9 +/- 85.3 mu mol/L, P = 0.02). Supplementation with synbiotic had a significant decrease in cesarean section rate (16.7 vs. 40.0%, P = 0.04), lower incidence of hyperbilirubinemic newborns (3.3 vs. 30.0%, P = 0.006), and newborns' hospitalization ( 3.3 vs. 30.0%, P = 0.006) compared with the placebo. Synbiotic supplementation did not affect plasma nitric oxide (NO) levels and other pregnancy outcomes. Overall, synbiotic supplementation among GDM women for 6 weeks had beneficial effects on serum hs-CRP, plasma TAC, GSH, and MDA; cesarean section; incidence of newborn's hyperbilirubinemia; and newborns' hospitalization but did not affect plasma NO levels and other pregnancy outcomes.