Effect of Probiotic Supplementation on Glycemic Control Among GDM − Study Protocol for a Randomized Clinical Trial

Abstract

Background: Diabetes is the ninth leading cause of death among women globally causing 2.1 million deaths per year. Pregnancy complicated with gestational diabetes mellitus (GDM) causes physiological resistance to insulin that predisposes to maternal (pregnancy-induced hypertension, macrosomia, and obstructed labor due to shoulder dystocia) and fetal (macrosomia, birth injuries, hypoglycemia, respiratory distress) complications associated with the GDM. Given the complications associated with GDM in South India, the study hypothesized that a novel idea of probiotics supplementation as adjunct therapy with comprehensive intervention would show considerable improvement in maternal glycemic control among GDM. Methods/Design: It is a single-center, double-blind randomized controlled trial. Study population: Expectant women with GDM in their second trimester were randomized to control and intervention group. Intervention: The package included supplementation with probiotics (probiotic capsules with routine care), while the control group: received a placebo capsule (placebo capsule with routine care) to GDM women. The study participants were followed up till delivery. Outcome measures: Maternal blood glucose levels as fasting and postprandial blood glucose levels are measured at the 20th, 32nd, and 40th weeks of gestational age. Secondary outcome measures: Maternal parameters are monitored at their regular follow-up visits, and neonatal parameters are measured after delivery. Statistical analysis: Descriptive and inferential analyses were performed that satisfied the per protocol compliance using the recent version of Statistical Package for the Social Sciences. Conclusion: Probiotic supplementation is one of the emerging trends that shows a significant impact on maternal blood glucose levels, which will in turn have beneficial effects on maternal and neonatal morbidity and mortality. In a developing country like India, with the growing burden of diabetes and GDM, developing an innovative effective intervention that promotes glycemic health that can easily be replicated across various settings will become a priority. If the intervention is concluded to be effective, this study would become a guideline model to reinforce probiotics as an intervention to treat GDM and contribute to improved maternal and neonatal health in South India.