Lp299v supplementation for chronic heart failure
Impact of Lactobacillus Plantarum 299v Probiotic Supplementation on Vascular Function and Exercise Capacity in Chronic Heart Failure With Reduced and Preserved Ejection Fraction.
This study is testing if taking Lp299v for 12 weeks can help people with heart failure improve their exercise ability, heart health, and overall quality of life compared to a placebo.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 21 Years to 89 Years |
| Sex | All |
| Sponsor | Medical College of Wisconsin Academic / other |
| Locations | 1 site (Milwaukee, Wisconsin) |
| Trial ID | NCT05752760 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effects of 12 weeks of Lp299v supplementation compared to a placebo on exercise capacity, cardiac biomarkers, quality of life, and vascular function in patients with heart failure. It focuses on individuals with either reduced or preserved ejection fraction who exhibit signs of inflammation. The study employs a randomized, double-blind, placebo-controlled design to ensure the reliability of results.
Who should consider this trial
Good fit: Ideal candidates include adults aged 21-89 with a clinical diagnosis of chronic heart failure and evidence of systemic inflammation.
Not a fit: Patients with heart failure due to severe valve disease or those with certain types of cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel approach to reducing inflammation and improving heart function in patients with chronic heart failure.
How similar studies have performed: Previous studies have shown promising results with similar probiotic interventions in related conditions, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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) Exclusion Criteria: * 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
Where this trial is running
Milwaukee, Wisconsin
- Medical College of Wisconsin — Milwaukee, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Michael E Widlansky, MD — Medical College of Wisconsin
- Study coordinator: Michael E Widlansky, MD
- Email: mwidlans@mcw.edu
- Phone: 414-955-6759
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.