Probiotics for Gestational Diabetes
(ProbioGDM Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it mentions that certain prescription medications, especially those related to gastric function or immunosuppressants, might affect the study results. It's best to discuss your current medications with the study team to see if they might interfere with the trial.
What evidence supports the effectiveness of the probiotic treatment for gestational diabetes?
Is the probiotic treatment safe for humans?
The studies on probiotics for gestational diabetes suggest that they are generally safe for humans, as they have been used in trials without significant safety concerns. Probiotics have shown beneficial effects on blood sugar levels and inflammation, which are important for managing gestational diabetes.34567
How is the 5-strain probiotic plus prebiotic treatment different from other treatments for gestational diabetes?
This treatment is unique because it uses a combination of probiotics (beneficial bacteria) and prebiotics (food for these bacteria) to improve gut health, which may help manage blood sugar levels in gestational diabetes. Unlike traditional treatments that focus on diet and insulin, this approach aims to restore the balance of gut bacteria, potentially offering a natural way to support metabolic health during pregnancy.138910
What is the purpose of this trial?
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.
Research Team
Graeme N Smith, MD, PhD
Principal Investigator
Queen's University
Eligibility Criteria
This trial is for pregnant individuals diagnosed with gestational diabetes between 24 and 31 weeks of gestation. Participants will be accepted into the study if they meet specific health criteria, but details on these are not provided.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the probiotic or placebo intervention from 24-31 weeks gestation until 6 weeks postpartum
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension (optional)
Participants may opt into continuation of treatment long-term until 6 months postpartum
Treatment Details
Interventions
- 5-strain probiotic plus prebiotic natural health product
Find a Clinic Near You
Who Is Running the Clinical Trial?
Queen's University
Lead Sponsor
Kingston Health Sciences Centre
Lead Sponsor
Queen's University
Lead Sponsor