Probiotic Supplement for Heart Failure

Overseen By Michael M Aljadah, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medical College of Wisconsin

Must not be taking: Steroids, Anti-inflammatories, Antibiotics, Probiotics

Disqualifiers: Severe valve disease, Cancer, Lung disease, others

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how the probiotic supplement Lactobacillus Plantarum 299v might benefit individuals with heart failure. Researchers aim to determine if taking this supplement for 12 weeks can enhance exercise ability, improve heart health markers, and boost overall quality of life compared to a placebo. Participants should have heart failure with either reduced or preserved heart function and exhibit signs of inflammation, identified by a specific blood test. This double-blind study ensures that neither participants nor researchers know who receives the probiotic or placebo until the study concludes. As an unphased trial, participants have the chance to contribute to groundbreaking research that could provide new insights into heart failure management.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications, but you cannot participate if you are currently taking steroids, anti-inflammatory treatments, antibiotics, or a Lactobacillus-based probiotic. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Lactobacillus plantarum 299v (Lp299v) is generally safe for use. This probiotic has undergone extensive study and is considered safe. One study found that Lp299v improved blood vessel function and reduced inflammation in people with heart disease, without major side effects.

These findings suggest that Lp299v is well-tolerated, with no serious negative effects reported in past research. This makes it a promising option for those considering participation in a clinical trial involving this probiotic. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for heart failure, which typically involve medications like ACE inhibitors, beta-blockers, or diuretics, the Lactobacillus Plantarum 299v (Lp299v) freeze-dried capsule offers a novel approach by using probiotics. Researchers are excited about this treatment because it harnesses beneficial bacteria to potentially improve heart health. Most heart failure treatments focus on managing symptoms and reducing strain on the heart, but Lp299v may work differently by targeting gut health and inflammation, potentially offering a new avenue to support heart function. This probiotic approach is particularly intriguing as it represents a non-invasive, natural supplement option, which could complement existing therapies and improve patient outcomes.

What evidence suggests that this probiotic supplement might be an effective treatment for heart failure?

Research has shown that Lactobacillus plantarum 299v (Lp299v), which participants in this trial may receive, can reduce inflammation and improve heart and blood vessel function. In some individuals with coronary artery disease, Lp299v enhanced blood vessel function and reduced inflammation without affecting other risk factors. Another study found that it lowered systolic blood pressure, leptin (a hormone related to fat storage), and fibrinogen (a protein involved in blood clotting). These benefits suggest that Lp299v might aid people with heart failure by reducing inflammation and supporting heart and blood vessel health. ^{2 4 5 6 7}

Who Is on the Research Team?

Michael E Widlansky

Principal Investigator

Medical College of Wisconsin

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

You must be between 21 and 89 years old.

You have heart failure symptoms and a specific level of heart function, as shown by a heart ultrasound.

You have signs of widespread inflammation in your body when you are screened for the trial.

Exclusion Criteria

You have severe heart problems caused by certain valve diseases.

You have a gastrointestinal illness that affects how your body absorbs probiotics.

You have chronic kidney disease with a very low eGFR level.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Lp299v or placebo supplementation for 12 weeks to assess impact on exercise capacity, cardiac biomarkers, and vascular function

12 weeks

Weekly visits (in-person) for monitoring and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Freeze Dried Potato Starch Capsule
• Lactobacillus Plantarum 299v Freeze Dried Capsule

Trial Overview 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.

How Is the Trial Designed?

Group I: Lp299v Experimental Treatment 1 Intervention

Subjects will consume 20 billion colony forming units of Lp299v (2 capsules) once daily for 12 weeks.

Group II: Placebo Control Placebo Group 1 Intervention

Subjects will consume potato starch (2 capsules) once daily for 12 weeks.

Lactobacillus Plantarum 299v Freeze Dried Capsule is already approved in European Union, United States for the following indications:

Approved in European Union as Lactiplantibacillus plantarum 299v for:

• Digestive health
• Iron absorption
• Irritable bowel syndrome

Approved in United States as Lactiplantibacillus plantarum 299v for:

• Digestive health
• Iron absorption
• Irritable bowel syndrome

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+

Advancing a Healthier Wisconsin

Collaborator

Trials

2

Recruited

110+

Published Research Related to This Trial

A rare case of endocarditis caused by Lactobacillus plantarum was reported in a patient with a bioprosthetic aortic valve, highlighting the unusual nature of this infection.

The patient responded well to both medical and surgical treatments, and the use of transesophageal echocardiography was crucial in monitoring the progression of the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Progression of Lactobacillus plantarum prosthetic valve endocarditis followed by transesophageal echocardiogram. Tavernese, A., Stelitano, M., Mauceri, A., et al.[2020]

In a 12-week clinical trial involving 100 overweight participants, the probiotic Lactobacillus plantarum strain LMT1-48 significantly reduced body weight and abdominal visceral fat compared to a placebo, indicating its potential effectiveness in weight management.

The treatment with LMT1-48 also improved metabolic markers, such as lowering insulin resistance and leptin levels, suggesting that this probiotic may help combat obesity-related health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Lactobacillus plantarum LMT1-48 on Body Fat in Overweight Subjects: A Randomized, Double-Blind, Placebo-Controlled Trial. Sohn, M., Jung, H., Lee, WS., et al.[2023]

In a study of 35 cancer patients receiving home enteral nutrition, Lactobacillus plantarum 299v (Lp299v) significantly increased serum albumin levels compared to a placebo, indicating potential benefits for nutritional status.

Lp299v also reduced gastrointestinal symptoms like vomiting and flatulence after 4 weeks, suggesting it may help alleviate discomfort associated with enteral nutrition, although it did not significantly improve overall quality of life compared to the placebo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of 4 weeks of Lactobacillus plantarum 299v supplementation on nutritional status, enteral nutrition tolerance, and quality of life in cancer patients receiving home enteral nutrition - a double-blind, randomized, and placebo-controlled trial. Kaźmierczak-Siedlecka, K., Folwarski, M., Ruszkowski, J., et al.[2021]

In a study using a rat model of colitis, Lactobacillus plantarum species 299 (LP299) did not improve the severity of colitis or gut permeability compared to untreated controls, indicating it may not be effective in this context.

The experiment involved 48 rats with induced colitis and assessed outcomes like colon macroscopic scoring and gut permeability, but LP299 treatment did not show any beneficial effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Probiotic therapy fails to improve gut permeability in a hapten model of colitis. Kennedy, RJ., Hoper, M., Deodhar, K., et al.[2019]

Lactobacillus plantarum 299v has been shown to improve gut health by increasing anti-inflammatory cytokines, which can enhance cancer treatment efficacy and reduce gastrointestinal side effects.

This probiotic also benefits patients with irritable bowel syndrome (IBS) by normalizing stool and alleviating abdominal pain, and it helps prevent Clostridium difficile-associated diarrhea in those undergoing antibiotic treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of Lactobacillus plantarum 299v in supporting treatment of selected diseases. Kaźmierczak-Siedlecka, K., Daca, A., Folwarski, M., et al.[2021]

Regular use of the probiotic Lactobacillus plantarum Tensia DSM 21380, as part of a dietary treatment, positively affects cardiovascular health by modulating intestinal microflora and improving blood pressure levels.

This research specifically targets patients with obesity and arterial hypertension, suggesting that incorporating this probiotic into their diet may enhance clinical and metabolic outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Influence of a low-calorie diet with inclusion of probiotic product containing bacterias Lactobacillus plantarum Tensia DSM 21380 on clinical and metabolic characteristics in patients with obesity and arterial hypertension]. Sharafetdinov, KhKh., Plotnikova, OA., Alekseeva, RI., et al.[2012]

In a study involving 49 adults with normal to mildly high cholesterol, the probiotic Lactobacillus plantarum ECGC 13110402 significantly reduced LDL cholesterol by 13.9% in those with baseline total cholesterol under 5mM and by 37.6% in those with baseline cholesterol over 6mM, indicating its potential efficacy in lowering cardiovascular risk.

The probiotic also led to a 6.6% reduction in systolic blood pressure and was well-tolerated with no gastrointestinal side effects reported, suggesting it could be a safe alternative or supplement to traditional cholesterol-lowering treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An in vivo assessment of the cholesterol-lowering efficacy of Lactobacillus plantarum ECGC 13110402 in normal to mildly hypercholesterolaemic adults. Costabile, A., Buttarazzi, I., Kolida, S., et al.[2020]

In a study involving 60 hypercholesterolaemic patients, supplementation with a mixture of three Lactobacillus plantarum strains led to a significant 13.6% reduction in total cholesterol levels after 12 weeks compared to a placebo.

The effectiveness of the Lactobacillus treatment was greater in patients with higher initial cholesterol levels, showing reductions in total cholesterol, LDL-cholesterol, and oxidised LDL-C, indicating that the probiotic's benefits may be more pronounced in those at greater cardiovascular risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cholesterol-lowering efficacy of Lactobacillus plantarum CECT 7527, 7528 and 7529 in hypercholesterolaemic adults. Fuentes, MC., Lajo, T., Carrión, JM., et al.[2013]

Lactiplantibacillus plantarum 299v (L. plantarum 299v) is a well-researched probiotic strain with over 170 publications, including more than 60 clinical studies, demonstrating its safety and efficacy in improving gastrointestinal health, particularly in reducing symptoms of irritable bowel syndrome (IBS).

This strain not only enhances iron absorption and status but also survives the harsh conditions of the gastrointestinal tract, making it suitable for various food applications and dietary supplements, with a stable shelf-life in freeze-dried formats.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lactiplantibacillus plantarum 299v (LP299V®): three decades of research. Nordström, EA., Teixeira, C., Montelius, C., et al.[2021]

Lactiplantibacillus plantarum (Lb. plantarum) has shown potential in reducing the risk of cardiovascular disease (CVD) by regulating metabolism, lowering blood glucose and lipids, and managing blood pressure.

The review emphasizes the importance of incorporating Lb. plantarum through fermented foods into daily diets, which could help alleviate CVD symptoms and improve overall health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Mechanisms of the Potential Probiotic Lactiplantibacillus plantarum against Cardiovascular Disease and the Recent Developments in its Fermented Foods. Wang, Z., Wu, J., Tian, Z., et al.[2022]

In a randomized clinical trial involving 218 adult ICU patients, the use of the probiotic Lactobacillus plantarum 299v did not significantly increase the number of days alive and out of the hospital compared to a placebo, indicating no improvement in patient outcomes.

The study found that the incidence of nosocomial infections was similar between the probiotic and placebo groups, and there were no serious adverse events associated with the probiotic, suggesting it is safe for use in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early and sustained Lactobacillus plantarum probiotic therapy in critical illness: the randomised, placebo-controlled, restoration of gut microflora in critical illness trial (ROCIT). Litton, E., Anstey, M., Broadhurst, D., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05752760

Pilot Study Lp299v Supplementation in Chronic Heart Failure Previous studies by the lab showed that supplementation of 20 billion cfu/day of Lactobacillus plantarum 299v (Lp299v) probiotic decreases systemic inflammation ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6205737/

Lactobacillus Plantarum 299v Supplementation Improves ... Lp299v improved vascular endothelial function and decreased systemic inflammation in men with CAD, independent of changes in traditional risk factors and TMAO.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/12450890/

Effect of Lactobacillus plantarum 299v on cardiovascular ... Results: Significant decreases in systolic blood pressure (P < 0.000), leptin (P < 0.000), and fibrinogen (P < 0.001) were recorded in the experimental group.

4. sciencedirect.com sciencedirect.com/topics/medicine-and-dentistry/lactobacillus-plantarum

Lactobacillus plantarum - an overview Studies have shown that oral Lp299v administration can improve vascular endothelial function and reduce the systemic inflammatory response in patients with ...

5. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/393203

Pilot Study Lp299v Supplementation in Chronic Heart Failure The goal of this study is to determine the impact of 12 weeks of Lp299v supplementation (20 million cfu/day vs. placebo) on exercise ...

6. fda.gov fda.gov/files/food/published/GRAS-Notice-000685---Lactobacillus-plantarum-strain-299v.pdf

GRAS Notice 685, Lactobacillus plantarum strain 299v The subject of this Generally Recognized as Safe (GRAS) determination is a strain ofthe probiotic bacterium Lactobacillus plantarum designated ...

7. webmd.com webmd.com/vitamins/ai/ingredientmono-1672/lactiplantibacillus-plantarum

Lactiplantibacillus Plantarum - Uses, Side Effects, and More Lactiplantibacillus plantarum (L. plantarum) is a type of probiotic ("good" bacteria) found in the mouth and gut. It's also found in fermented foods.