Probiotics for Gestational Diabetes

(ProbioGDM Trial)

Overseen By Kira King, BHSc, MLT

Age: Any Age

Sex: Female

Trial Phase: Phase 2

Sponsor: Queen's University

Must not be taking: Antibiotics, Antifungals, Immunosuppressants

Disqualifiers: Severe hypertension, Preeclampsia, Substance use, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 7

Duration: Approximately 16-19 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a specific probiotic treatment can help manage blood sugar levels and improve gut health in pregnant women with gestational diabetes. Probiotics, which are friendly bacteria, can support a healthy gut. The study will test their effectiveness compared to a placebo. Participants must have a single pregnancy with gestational diabetes and be willing to use a glucose monitor and provide samples. The goal is to determine if these probiotics offer a natural way to improve glucose control during pregnancy. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that probiotics and prebiotics are generally safe during pregnancy and breastfeeding. Studies indicate that these products are usually well-tolerated. Some individuals have reported mild side effects, such as changes in bowel movements and increased vaginal discharge, but no major safety concerns have emerged. Overall, probiotics have undergone testing in many trials with pregnant women without major issues. This suggests that while minor side effects might occur, serious problems are unlikely. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for gestational diabetes?

Unlike the standard treatments for gestational diabetes, which often involve insulin injections or the use of oral medications like metformin, the investigational treatment in this trial uses a 5-strain probiotic combined with a prebiotic. This approach is unique because it targets gut health, potentially influencing blood sugar levels by altering the gut microbiome. Researchers are excited about this treatment because it offers a natural alternative that might improve metabolic health during pregnancy without the side effects associated with pharmaceuticals.

What evidence suggests that this probiotic treatment might be effective for gestational diabetes?

This trial will compare a 5-strain probiotic plus prebiotic natural health product with a placebo in women with gestational diabetes. Studies have shown that probiotics can help these women manage blood sugar and improve insulin use. Research suggests that probiotic supplements may lower the risk of insulin resistance, a condition where the body doesn't use insulin effectively. Some studies also indicate that probiotics can help control blood sugar levels more effectively. Specifically, one study found that probiotics could lower fasting blood sugar levels in women with gestational diabetes. While these results are promising, more research is needed to fully understand their benefits during pregnancy. ^{4 5 6 7 8}

Who Is on the Research Team?

Graeme N Smith, MD, PhD

Principal Investigator

Queen's University

Are You a Good Fit for This Trial?

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

Singleton pregnancy

Live fetus (documented positive fetal heartbeat prior to recruitment)

Willing to provide fecal swab samples

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

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Probiotic Experimental Treatment 1 Intervention

The investigational product is a 5-strain probiotic plus prebiotic natural health product.

Group II: Placebo Placebo Group 1 Intervention

Identically appearing placebo.

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+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9608451/

Probiotics in the Prevention and Treatment of Gestational ...

According to the analyzed data, probiotics have a positive influence on glycemic control and are a promising tool for lowering the frequency of GDM.

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S2666577823001272

Systematic Review The role of probiotics and synbiotics on ...

Probiotic and synbiotic supplementations reduced the risk of insulin resistance and improved glycemic control, blood lipid profiles, and inflammation

3.

withpower.com

withpower.com/trial/phase-2-gestational-diabetes-mellitus-gdm-9-2025-05585

Probiotics for Gestational Diabetes · Info for Participants

Research shows that probiotic supplements can help improve blood sugar control and insulin sensitivity in women with gestational diabetes. They also seem to ...

4.

mdpi.com

mdpi.com/2079-7737/13/3/158

Probiotics Supplementation during Pregnancy: Can They ...

Conclusion: up to the present day, there is only preliminary clinical data and not conclusive results for probiotics' healthy effects during pregnancy, and it ...

5.

bmcendocrdisord.biomedcentral.com

bmcendocrdisord.biomedcentral.com/articles/10.1186/s12902-024-01751-w

The effect of probiotics on gestational diabetes mellitus

This analysis indicated that probiotics improved glycemic indices in GDM patients. The results revealed that probiotics reduce serum FBS, FBI, ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8993604/

The effect of probiotics on gestational diabetes and its ...

This study was aimed to evaluate the effect of probiotics consumption on gestational diabetes (GD) and its complications in pregnant mother and newborn.

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8308823/

Are Probiotics and Prebiotics Safe for Use during ...

Probiotic and prebiotic products are safe for use during pregnancy and lactation. One study reported increased risk of vaginal discharge and changes in stool ...

8.

mdpi.com

mdpi.com/2304-8158/13/24/4024

The Safety of Probiotics Intended for Use in Pregnant and ...

Overall, probiotic trials involving pregnant or lactating women have shown that these products are usually well-tolerated and safe although adverse effects may ...