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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
Age between 21-89 years old
Clinical diagnosis of CHF in the six months prior to enrollment along with an echocardiogram documenting diastolic dysfunction with an ejection fraction ≥50%, and a H2FpEFF score of ≥6
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You must be between 21 and 89 years old.
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You have been diagnosed with heart failure in the past six months, and tests show specific heart function issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Brachial Artery Flow Mediated Dilation (FMD%)
Carotid-Femoral Pulse Wave Velocity (cfPWV)
Maximal Oxygen Consumption (VO2Max)
Secondary outcome measures
Brachial Artery Absolute Flow Mediated Dilation (FMDmm)
Change in Galectin-3
Change in serum Soluble Suppression Tumorigenesis (SST2)
+4 more

Trial 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.

Find a Location

Who is running the clinical trial?

Advancing a Healthier WisconsinUNKNOWN
1 Previous Clinical Trials
90 Total Patients Enrolled
Medical College of WisconsinLead Sponsor
608 Previous Clinical Trials
1,162,491 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

Media Library

Lactobacillus Plantarum 299v Freeze Dried Capsule (Probiotic) Clinical Trial Eligibility Overview. Trial Name: NCT05752760 — N/A
Heart Failure Research Study Groups: Lp299v, Placebo Control
Heart Failure Clinical Trial 2023: Lactobacillus Plantarum 299v Freeze Dried Capsule Highlights & Side Effects. Trial Name: NCT05752760 — N/A
Lactobacillus Plantarum 299v Freeze Dried Capsule (Probiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05752760 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial accept volunteers outside of the 35-year age bracket?

"Due to the requirements of the research, enrolment for this study is limited to persons aged 21-89."

Answered by AI

Am I eligible to participate in the research project?

"This study, which seeks to recruit 20 people in total, is open to those between 21 and 89 years old with a diagnosis of heart failure."

Answered by AI

Are there any opportunities to take part in this investigation at the moment?

"Verified. Clinicaltrials.gov has this trial listed as actively enrolling patients, with the original posting being on February 20th of 2021 and an update occurring one day later."

Answered by AI

How many subjects are enrolled in this scientific experiment?

"Affirmative. Clinicaltrials.gov denotates that this medical trial, first published on February 20th 2021 is still looking for participants. Only a total of 20 individuals are needed at one site to complete the study."

Answered by AI

What are the projected effects of this trial?

"The main objective of this research, assessed over approximately 12 weeks, is to evaluate Brachial Artery Flow Mediated Dilation (FMD%). Additional quantitative parameters comprise Resting Shear Stress of the Brachial Artery indicative of vascular rigidity, velocity at rest corresponding to vascular firmness and alteration in serum Soluble Suppression Tumorigenesis (SST2) as a marker of cardiac fibrosis."

Answered by AI
~6 spots leftby Oct 2024