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Dietary Supplement

Probiotics for Diabetic Cardiomyopathy and Heart Failure

N/A
Waitlist Available
Research Sponsored by Mahavir Singh, DVM, MS, PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diabetic subjects with high blood glucose levels
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will show that ketone bodies can help Type 1 Diabetes patients and prevent cardiac problems that may arise from the condition.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects aren't listed, probiotics generally may cause digestive discomfort such as gas or bloating, especially when first starting them. They're usually considered safe but can pose risks for those with weakened immune systems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am diabetic with high blood sugar levels.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Measure-I
Measure-II
Secondary study objectives
Measure-I

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Diabetic SubjectsExperimental Treatment1 Intervention
Diabetic subjects: 10 subjects: No intervention (placebo). 10 subjects: Intervention (probiotic)
Group II: Control subjects (non-diabetic).Experimental Treatment1 Intervention
Control subjects (non-diabetic): 10 subjects: No intervention (placebo). 10 subjects: Intervention (probiotic)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Probiotic
2013
Completed Phase 4
~3570

Find a Location

Who is running the clinical trial?

Mahavir Singh, DVM, MS, PhDLead Sponsor
National Institutes of Health (NIH)NIH
2,810 Previous Clinical Trials
8,159,592 Total Patients Enrolled
4 Trials studying Cardiomyopathy
1,537 Patients Enrolled for Cardiomyopathy

Media Library

Probiotic (Dietary Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT05571865 — N/A
Cardiomyopathy Research Study Groups: Control subjects (non-diabetic)., Diabetic Subjects
Cardiomyopathy Clinical Trial 2023: Probiotic Highlights & Side Effects. Trial Name: NCT05571865 — N/A
Probiotic (Dietary Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05571865 — N/A
~21 spots leftby Jun 2026
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