Probiotics for Diabetic Cardiomyopathy and Heart Failure

Overseen By Mahavir Singh, DVM, MS, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Louisville

Disqualifiers: Glucose, Cardiac, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 4 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether probiotics can help people with type 1 diabetes (T1D) avoid heart problems linked to diabetes. Researchers aim to determine if these probiotics can prevent diabetic cardiomyopathy, a heart muscle disease caused by diabetes. The trial includes two groups: non-diabetic individuals and those with T1D, with each group receiving either a probiotic (beneficial bacteria) or a placebo. Individuals with high blood sugar levels due to diabetes might be suitable candidates for this trial. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research on diabetes and heart health.

Do I need to stop my current medications for this trial?

The trial information does not specify if you need to stop your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that probiotics are usually safe for most people. Studies have found that probiotics can be safe for individuals with various health conditions, including heart problems. For instance, one study found no serious side effects from probiotics in people with heart failure. Another study on individuals with metabolic syndrome (a group of conditions that increase the risk of heart disease and diabetes) showed that probiotics were safe and even improved their health.

While these studies are encouraging about the safety of probiotics, safety can differ from person to person. Overall, current evidence suggests that probiotics are safe for most people when used as directed. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using probiotics for diabetic cardiomyopathy and heart failure because of their potential to improve heart health through a natural and gut-focused approach. Unlike standard treatments like ACE inhibitors or beta-blockers, which directly target heart function, probiotics work by promoting a healthier gut microbiome. This can have a systemic effect, potentially reducing inflammation and improving metabolic health, which are key factors in diabetic heart conditions. By addressing the root causes rather than just managing symptoms, probiotics could offer a more holistic and side-effect-free alternative.

What evidence suggests that probiotics might be an effective treatment for diabetic cardiomyopathy?

This trial will evaluate the effects of probiotics on diabetic cardiomyopathy and heart failure. Research has suggested that probiotics might aid conditions like diabetes and heart disease by helping manage cholesterol levels, which benefits heart health. Some studies found that probiotics improved heart health markers in people with type 2 diabetes. However, other research did not show improvements in blood sugar control. Despite mixed results, the potential heart benefits make probiotics worth considering for heart issues related to diabetes. Participants in this trial will be divided into two groups: diabetic subjects and control subjects (non-diabetic), with each group receiving either a probiotic intervention or a placebo. ^{4 5 6 7 8}

Who Is on the Research Team?

Mahavir Singh, DVM, MS, PhD

Principal Investigator

University of Louisville School of Medicine

Are You a Good Fit for This Trial?

This trial is for people with type 1 diabetes who have high blood sugar levels and are at risk of developing heart problems like diabetic cardiomyopathy (DCM) and heart failure. It's not suitable for those with other health conditions that could affect their blood sugar or heart function.

Inclusion Criteria

I am diabetic with high blood sugar levels.

Exclusion Criteria

I have health conditions that affect my blood sugar and heart.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a placebo or probiotic intervention to assess the effects of ketone bodies on diabetic cardiomyopathy

4 years

Follow-up

Participants are monitored for safety and effectiveness after treatment, including biochemical estimation of biomarkers and cardiac function evaluation

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Probiotic

Trial Overview The study is testing the effects of a probiotic on preventing serious metabolic issues in type 1 diabetes, particularly focusing on how it might help avoid diabetic cardiomyopathy, which affects the heart muscle.

How Is the Trial Designed?

Group I: Diabetic Subjects Experimental Treatment 1 Intervention

Diabetic subjects: 10 subjects: No intervention (placebo). 10 subjects: Intervention (probiotic)

Group II: Control subjects (non-diabetic). Experimental Treatment 1 Intervention

Control subjects (non-diabetic): 10 subjects: No intervention (placebo). 10 subjects: Intervention (probiotic)

Probiotic is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Probiotics for:

• Supports gut health
• Reduces symptoms of irritable bowel syndrome (IBS)
• Supports immune system

Approved in United States as Probiotics for:

• Supports gut health
• Reduces symptoms of irritable bowel syndrome (IBS)
• Supports immune system

Approved in Canada as Probiotics for:

• Supports gut health
• Reduces symptoms of irritable bowel syndrome (IBS)
• Supports immune system

Who Is Running the Clinical Trial?

University of Louisville

Lead Sponsor

Trials

353

Recruited

76,400+

Mahavir Singh, DVM, MS, PhD

Lead Sponsor

Trials

1

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12176072/

The Promising Role of Probiotics in the Prevention ... Probiotics may offer a beneficial, non-pharmacological option to support conventional CAD therapies, particularly by targeting key modifiable risk factors.

2. frontiersin.org frontiersin.org/journals/nutrition/articles/10.3389/fnut.2025.1612021/full

The beneficial effects of probiotics on patients with ... Probiotics, particularly monotherapy for LDL and combination therapy for HDL, exhibited potential to improve lipid profiles in CHD patients.

3. mdpi.com mdpi.com/1422-0067/23/24/15898

Clinical Evidence on the Potential Beneficial Effects of ... Probiotics and prebiotics may help treat metabolic disorders such as obesity, diabetes, and cardiovascular disease, according to growing evidence. They have ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2405457725003109

Effect of probiotic supplementation on glycemic control in ... Probiotic supplementation for 12 weeks did not improve glycemic control, lipid or inflammatory markers in patients with type 2 diabetes.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9006598/

Effects of probiotic supplementation on major ... Overall, probiotic supplementation for 6 weeks led to a significant improvement in major CVD-related parameters in populations with T2DM.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8401746/

Potential Benefits of Probiotics and Prebiotics for Coronary ... The effects of probiotic supplementation on metabolic status in type 2 diabetic patients with coronary heart disease. Diabetol. Metab. Syndr. 2018;10:1–7 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10290309/

Effect of probiotic supplementation on in-hospital mortality in ... From the perspective of heart failure, studies have shown that probiotic supplementation ... outcomes in patients with chronic heart failure after ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0939475325002546

Review Efficacy and safety of probiotic and synbiotic ... MetS, a non-communicable disease, has become a global menace, frequently ... probiotic supplements to improve the health outcomes of patients with MetS.