A Probiotic Based Intervention in Pregnancies Complicated by GDM

Overview

This study is a single center randomized control trial of a probiotic based intervention in pregnancies complicated by gestational diabetes. A healthy gut microbiome is now recognized as a key component of human health and dysbiosis of the gut microbiome, including lack of diversity, is believed to contribute to the development of many diseases and alter glucose control. The study aims to explore whether this probiotic intervention will improve glucose control and change the gut microbiome. Participants may be enrolled and randomized after diagnosis of gestational diabetes between 24 and 31 weeks gestation. 115 participants will be randomized in a ratio of 2 in the probiotic intervention group to 1 in the placebo group. Participants will stop taking the intervention at 6 weeks postpartum. At this time, they will be unblinded and offered the option of participating in an open-label extension of the intervention until 6 months postpartum.

The chosen study design is a single-center, randomized, double-blind, parallel-group, placebo-controlled trial. Participants will be randomized by 2:1 to probiotic intervention or placebo. This is an exploratory study examining the impact of the intervention on glucose control among pregnant persons diagnosed with gestational diabetes. Participants may be enrolled and randomized after diagnosis of GDM between 240 and 316 weeks gestation. Participants will stop taking the intervention at 6 weeks postpartum. At this time, they will be unblinded and offered the option of participating in an open-label extension of the intervention until 6 months postpartum. Participants will be seen for up to 4 study visits: 3 mandatory visits in the main study and 1 in the optional extension. Brief visit outlines are below. Visit 1 at 24-31 weeks gestation: * eligibility confirmation * consent * randomization * weight, height, blood pressure, method of glucose control from chart * dispense investigational product * baseline survey * pregnancy history questionnaire * Diet Screening for Adults in Canada (D-SAC) * Automated Self-Administered 24-Hour Dietary Recall (ASA) x2 * Libre2 1 week of monitoring data * concommitant medication log * maternal rectal swab Visit 2 at 37 weeks gestation: * weight, height, blood pressure, method of glucose control from chart * dispense and reconcile investigational product * D-SAC * ASA x2 * Libre2 1 week of monitoring data * concommitant medication log * maternal rectal swab * adverse event log Delivery: * infant consent * weight, height, blood pressure, method of glucose control from chart * delivery chart review * Libre2 1 week of monitoring data * weigh placenta * concommitant medication log * adverse event log Visit 3 at 6 weeks postpartum: * reconcile investigational product * unblind * postpartum survey * D-SAC * ASA x2 * concommitant medication log * maternal rectal swab * infant fecal swab * adverse event log * study completion form Optional Open Label Extension - At 6 weeks postpartum, once all study components are complete, participants will be unblinded and invited to participate in an open label, single arm extension of the intervention till 6 months postpartum. Participants who agree to participate in the extension of the intervention will be provided with additional open-label product until 6 months postpartum. Visit E1 (open label extension, visit done with V3) * enroll in extension if desired * dispense open label product * maternal and infant consent Visit E2 at 6 months postpartum: * Chart review * D-SAC * ASA x2 * concommitant medication log * maternal rectal swab * infant fecal swab * adverse event log * study completion form