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Probiotic
Probiotic Supplement for Heart Failure
N/A
Recruiting
Led By Michael E Widlansky, MD
Research Sponsored by Medical College of Wisconsin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Summary
This trial will study how a probiotic supplement affects exercise capacity, biomarkers, quality of life, and vascular function in people with HFrEF and inflammation.
Who is the study for?
This trial is for adults aged 21-89 with heart failure diagnosed in the last six months, having either reduced ejection fraction (≤40%) or preserved ejection fraction (≥50%) and inflammation indicated by high C-reactive protein levels. Excluded are those with severe valve disease, certain GI illnesses, pregnant women, recent antibiotic use, severe kidney/lung diseases, active infections or inflammatory diseases, cancer with low survival expectancy, liver failure, on blood thinners like Warfarin or taking Lactobacillus probiotics.
What is being tested?
The study tests if a probiotic called Lp299v can improve exercise capacity and quality of life over 12 weeks compared to a placebo in people with different types of heart failure. It's randomized and double-blind meaning neither participants nor researchers know who gets the real treatment versus placebo during the study.
What are the potential side effects?
Potential side effects from Lp299v may include digestive discomfort such as gas or bloating since it's a probiotic supplement. However specific side effects will be monitored throughout the trial given that this is an investigation into its safety and efficacy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Brachial Artery Flow Mediated Dilation (FMD%)
Carotid-Femoral Pulse Wave Velocity (cfPWV)
Maximal Oxygen Consumption (VO2Max)
Secondary study objectives
Brachial Artery Absolute Flow Mediated Dilation (FMDmm)
Change in Galectin-3
Change in serum Soluble Suppression Tumorigenesis (SST2)
+4 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Lp299vExperimental Treatment1 Intervention
Subjects will consume 20 billion colony forming units of Lp299v (2 capsules) once daily for 12 weeks.
Group II: Placebo ControlPlacebo Group1 Intervention
Subjects will consume potato starch (2 capsules) once daily for 12 weeks.
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Who is running the clinical trial?
Advancing a Healthier WisconsinUNKNOWN
1 Previous Clinical Trials
90 Total Patients Enrolled
Medical College of WisconsinLead Sponsor
631 Previous Clinical Trials
1,181,938 Total Patients Enrolled
2 Trials studying Heart Failure
61 Patients Enrolled for Heart Failure
Michael E Widlansky, MDPrincipal InvestigatorMedical College of Wisconsin
2 Previous Clinical Trials
41 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have severe heart problems caused by certain valve diseases.You have a gastrointestinal illness that affects how your body absorbs probiotics.You must be between 21 and 89 years old.You have chronic kidney disease with a very low eGFR level.You have heart failure symptoms and a specific level of heart function, as shown by a heart ultrasound.You have signs of widespread inflammation in your body when you are screened for the trial.You are currently taking or have taken steroids or anti-inflammatory treatments (except for certain types) in the past 14 days.Your blood doesn't have enough infection-fighting white blood cells.You have cancer other than non-melanoma skin cancer, localized prostate cancer, or localized breast cancer, and your doctor expects you to live less than one year.You have lung conditions like COPD, emphysema, or pulmonary fibrosis.You have been diagnosed with congestive heart failure and have a recent test showing that your heart is not pumping properly.You have been diagnosed with heart failure in the past six months, and tests show specific heart function issues.You have severe liver problems.You are expected to need heart surgery during the study.You are taking blood thinners like Coumadin or Warfarin.You are currently taking a Lactobacillus-based probiotic as an outpatient.You cannot walk on a treadmill or use a bicycle for exercise testing.You are allergic to the Lp299v probiotic supplement.
Research Study Groups:
This trial has the following groups:- Group 1: Lp299v
- Group 2: Placebo Control
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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