NCT05752760Completed
Pilot Study Lp299v Supplementation in 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.
Source: ClinicalTrials.gov · Last updated 1 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 10 (actual)
- First submitted
- 21 Feb 2023
- Start date
- 20 Feb 2023
- Primary completion date
- 31 Mar 2025
- Lead sponsor
- Medical College of Wisconsin
- Diseases
- Heart failure
- NCT number
- NCT05752760
What you commit to
- Study type: Interventional
- Participants enrolled: 10
- From 20 Feb 2023 to the primary completion date, 31 Mar 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who are receiving Vitamin K antagonists such as Coumadin or Warfarin
- Currently taking a Lactobacillus based probiotic as an outpatient at the time of enrollment
Other illness
- 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)
- 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
- Allergy to Lp299v probiotic supplement
Lab values
- Chronic Kidney Disease with eGFR ≤ 30 mL/min
- Neutropenia (Absolute Neutrophil Count (ANC) \< 1800/mm3)
Other
- Pregnancy
- Inability to give informed consent or follow the study protocol
- On antibiotics at the time of enrollment or within one month of enrollment
- Patients who are unable to walk on treadmill or use a bicycle to participate in exercise testing
Who the study is looking for
- 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)
Age in the registry: 21 years to 89 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical College of Wisconsin Coordinator of this site? Confirm its status | Milwaukee | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.