A Probiotic Based Intervention in Pregnancies Complicated by GDM

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.

NCT Number	NCT06794723
Lead Sponsor	Queen's University
Conditions	Gestational Diabetes Mellitus (GDM), Microbiome, Human
Enrollment	173 participants
Start Date	2025-10-01
Primary Completion	2028-09-30 (estimated)
Study Completion	2029-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-06-06