173 Participants Needed

Probiotics for Gestational Diabetes

(ProbioGDM Trial)

JP
KK
Overseen ByKira King, BHSc, MLT
Prior Safety DataThis treatment has passed at least one previous human 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?

Research shows that probiotic supplements can help improve blood sugar control and insulin sensitivity in women with gestational diabetes. They also seem to positively affect gut health, which may play a role in managing this condition.12345

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

GN

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

I am 16 years old or older.
Plan to reside in the study area at least until delivery and to deliver at Kingston Health Sciences Center (KHSC)
Singleton pregnancy
See 9 more

Exclusion Criteria

I am currently experiencing severe pregnancy complications.
Pill swallowing phobia or inability to swallow pills
Not taking any other probiotic supplements during the study intervention period
See 9 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
1 visit (in-person)

Treatment

Participants receive the probiotic or placebo intervention from 24-31 weeks gestation until 6 weeks postpartum

Approximately 16-19 weeks
3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks postpartum
1 visit (in-person)

Open-label extension (optional)

Participants may opt into continuation of treatment long-term until 6 months postpartum

4.5 months
2 visits (in-person)

Treatment Details

Interventions

  • 5-strain probiotic plus prebiotic natural health product
Trial Overview The study tests a probiotic plus prebiotic product against a placebo to see if it improves glucose control and alters the gut microbiome in pregnancies affected by gestational diabetes. It's a randomized trial where twice as many participants receive the real treatment compared to the placebo.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ProbioticExperimental Treatment1 Intervention
The investigational product is a 5-strain probiotic plus prebiotic natural health product.
Group II: PlaceboPlacebo Group1 Intervention
Identically appearing placebo.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Queen's University

Lead Sponsor

Kingston Health Sciences Centre

Lead Sponsor

Trials
312
Recruited
112,000+

Queen's University

Lead Sponsor

Trials
382
Recruited
122,000+

References

Probiotic supplements alleviate gestational diabetes mellitus by restoring the diversity of gut microbiota: a study based on 16S rRNA sequencing. [2021]
Effect of probiotic yoghurt on plasma glucose in overweight and obese pregnant women: a randomized controlled clinical trial. [2020]
Effects of probiotic supplements on insulin resistance in gestational diabetes mellitus: A double-blind randomized controlled trial. [2023]
The effect of probiotic and synbiotic use on glycemic control in women with gestational diabetes: A systematic review and meta-analysis. [2022]
The Effects of Probiotic Supplementation on Genetic and Metabolic Profiles in Patients with Gestational Diabetes Mellitus: a Randomized, Double-Blind, Placebo-Controlled Trial. [2022]
Probiotics for the Prevention of Gestational Diabetes Mellitus in Overweight and Obese Women: Findings From the SPRING Double-Blind Randomized Controlled Trial. [2019]
Effects of probiotics on blood glucose, biomarkers of inflammation and oxidative stress in pregnant women with gestational diabetes mellitus: A meta-analysis of randomized controlled trials. [2021]
Effect of probiotic yogurt on gestational diabetes mellitus: A systematic review and meta-analysis. [2023]
Association between Probiotic Yogurt Intake and Gestational Diabetes Mellitus: A Case-Control Study. [2022]
Probiotic Supplement for the Prevention of Gestational Diabetes: A Meta-Analysis of Randomized Controlled Trials. [2023]
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