Pilot Study Lp299v Supplementation in Chronic Heart Failure

Description

The goal of this study is to determine the impact of 12 weeks of Lp299v supplementation (20 million cfu/day vs. placebo) on exercise capacity, circulating biomarkers of cardiac remodeling, quality of life, and vascular endothelial function in humans with heart failure and reduced ejection fraction (HFrEF) and heart failure with preserved ejection fraction (HFpEF) who have evidence of residual inflammation based on an elevated C-reactive protein level. This will be done in the setting of a randomized, double-blind, placebo-controlled trial.

Conditions

Heart Failure, Heart Failure with Reduced Ejection Fraction, Heart Failure, Systolic, Heart Failure with Preserved Ejection Fraction, Heart Failure, Diastolic

Study Overview

Study Details

Study overview

The goal of this study is to determine the impact of 12 weeks of Lp299v supplementation (20 million cfu/day vs. placebo) on exercise capacity, circulating biomarkers of cardiac remodeling, quality of life, and vascular endothelial function in humans with heart failure and reduced ejection fraction (HFrEF) and heart failure with preserved ejection fraction (HFpEF) who have evidence of residual inflammation based on an elevated C-reactive protein level. This will be done in the setting of a randomized, double-blind, placebo-controlled trial.

Impact of Lactobacillus Plantarum 299v Probiotic Supplementation on Vascular Function and Exercise Capacity in Chronic Heart Failure with Reduced and Preserved Ejection Fraction.

Pilot Study Lp299v Supplementation in Chronic Heart Failure

Condition
Heart Failure
Intervention / Treatment

-

Contacts and Locations

Milwaukee

Medical College of Wisconsin, Milwaukee, Wisconsin, United States, 53226

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Age between 21-89 years old
  • * Clinical diagnosis of Congestive Heart Failure (CHF) in the six months prior to enrollment along with an echocardiogram documenting systolic dysfunction with ejection fraction ≤40%
  • * 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
  • * New York Heart Association (NYHA) Class II-IIID heart failure symptoms with either ischemic or non-ischemic etiology OR similar diagnosis with congestive heart failure (CHF) along with an echocardiogram documenting an LV ejection fraction of 50% or more with similar NYHA classification as those with LVEF of 40% or less
  • * Evidence of systemic inflammation at baseline (C-reactive protein ≥ 2 mg/L at the time of screening)
  • * Heart failure due to severe valve disease such as Aortic Stenosis, Mitral Regurgitation, or Mitral Stenosis
  • * Cancer besides non-melanoma skin carcinomas or localized prostate and breast cancer at the time of enrollment with life expectancy \<1 year
  • * Lung disease such as Chronic Obstructive Pulmonary Disease (COPD), emphysema, or Pulmonary fibrosis
  • * Active inflammatory disease or infectious disease at the time of enrollment
  • * Current treatment (or use within the past 14 days) of steroids or anti-inflammatory treatments (excluding non-steroidal anti-inflammatory medications or steroids used solely for IV contrast dye allergy)
  • * Chronic Kidney Disease with eGFR ≤ 30 mL/min
  • * Hepatic Failure (Child's Class B or C)
  • * Patients with Gastrointestinal (GI) tract illness such as short gut syndrome, inflammatory bowel disease, or an ileostomy, such that probiotic absorption would be altered
  • * Anticipated need for cardiac surgery during the projected study period for the subject
  • * Pregnancy
  • * Patients who are receiving Vitamin K antagonists such as Coumadin or Warfarin
  • * Neutropenia (Absolute Neutrophil Count (ANC) \< 1800/mm3)
  • * Inability to give informed consent or follow the study protocol
  • * On antibiotics at the time of enrollment or within one month of enrollment
  • * Currently taking a Lactobacillus based probiotic as an outpatient at the time of enrollment
  • * Patients who are unable to walk on treadmill or use a bicycle to participate in exercise testing
  • * Allergy to Lp299v probiotic supplement

Ages Eligible for Study

21 Years to 89 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Medical College of Wisconsin,

Michael E Widlansky, MD, PRINCIPAL_INVESTIGATOR, Medical College of Wisconsin

Study Record Dates

2026-03-01