Pilot Study Lp299v Supplementation in Chronic Heart Failure

Phase

N/A

Condition

Hyponatremia

Chest Pain

Congestive Heart Failure

Treatment

Lactobacillus Plantarum 299v Freeze Dried Capsule

Freeze Dried Potato Starch Capsule

Clinical Study ID

NCT05752760

45284

Ages 21-89
All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Age between 21-89 years old
Clinical diagnosis of Congestive Heart Failure (CHF) in the six months prior toenrollment along with an echocardiogram documenting systolic dysfunction withejection fraction ≤40%
Clinical diagnosis of CHF in the six months prior to enrollment along with anechocardiogram documenting diastolic dysfunction with an ejection fraction ≥50%, anda H2FpEFF score of ≥6
New York Heart Association (NYHA) Class II-IIID heart failure symptoms with eitherischemic or non-ischemic etiology OR similar diagnosis with congestive heart failure (CHF) along with an echocardiogram documenting an LV ejection fraction of 50% ormore 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 thetime of screening)

Exclusion

Exclusion Criteria:

Heart failure due to severe valve disease such as Aortic Stenosis, MitralRegurgitation, or Mitral Stenosis
Cancer besides non-melanoma skin carcinomas or localized prostate and breast cancerat the time of enrollment with life expectancy <1 year
Lung disease such as Chronic Obstructive Pulmonary Disease (COPD), emphysema, orPulmonary 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-inflammatorytreatments (excluding non-steroidal anti-inflammatory medications or steroids usedsolely 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 bealtered
Anticipated need for cardiac surgery during the projected study period for thesubject
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 ofenrollment
Patients who are unable to walk on treadmill or use a bicycle to participate inexercise testing
Allergy to Lp299v probiotic supplement

Study Design

Lactobacillus Plantarum 299v Freeze Dried Capsule

February 20, 2023

March 01, 2026

Study Description

Heart failure (HF) has significant morbidity and mortality and is one of the leading causes of hospital admissions in the United States. In 2017, almost 1 million people were affected and responsible for 1.2 million hospitalizations in the United States alone. Prognosis is poor for patients with HF despite significant medical therapy regimens and device therapy. Worldwide, mortality is as high as 17% during initial hospitalization, as high as 45% within one year of admission, and greater than 50% within five years. According to the Wisconsin Department of Health Services, mortality rates for HF have been increasing in the state since 1980. Wisconsin also consistently had higher rates of HF compared to the remaining states.

Emerging data suggest targeting the gut microbiota in HF could be a safe and effective alternative for mitigating inflammation. HF patients have increased systemic circulating endotoxins and lipopolysaccharides due to impaired gut-barrier function, secondary to gut congestion and reduced cardiac output, which drives systemic inflammation. The gut flora of patients with HF also includes more pathogenic bacteria species (candida, campylobacter, shigella, and yersinia) compared to patients with normal heart function.

Previous studies by the lab showed that supplementation of 20 billion cfu/day of Lactobacillus plantarum 299v (Lp299v) probiotic decreases systemic inflammation in men with stable coronary artery disease (CAD), and also improves vascular endothelial function (measured by endothelium-dependent vasodilation in the brachial artery and by nitric-oxide dependent vasodilation of resistance arterioles from CAD patients). The investigators have shown that there are significantly decreased levels of IL-8, IL-12 and Leptin in Lp299v-supplemented patients with CAD. Leptin is known to increase IL-6 (which drives increased C-reactive protein expression), IL-8, IL-12 and TNF-α levels, all which activate pro-inflammatory immune responses leading to vasoconstriction and vascular stiffness. Further, our data suggests Lp299v has a significant, favorable anti-inflammatory effect on signaling pathways (NLRP3, IL-6, IL-1β) shown to be important to chronic inflammation in heart failure.

Therefore, the investigators plan to perform a pilot study targeting the gut microbiota of patients with HF with oral supplementation with 20 billion cfu/day of Lp299 and determine if Lp299v improves peak oxygen consumption (measured by VO2 max testing), endothelial function (measured by brachial artery flow-mediated dilation), and vascular stiffness (measured by peak wave velocity). We plan to test the hypothesis that Lp299v will improve these measures in the setting of a randomized, double-blind, placebo-controlled clinical trial of 20 subjects. The investigators will additionally test if Lp299v supplementation improves circulating biomarkers of inflammation and cardiac remodeling in chronic heart failure, as well as if it improves the quality of life in patients using the Minnesota Living with Heart Failure Questionnaire and the Kansas City Cardiomyopathy Questionnaire.

Connect with a study center

Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United States
Active - Recruiting

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