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

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the treatment Lactobacillus plantarum 299v for heart failure?

Research shows that Lactobacillus plantarum strains can lower cholesterol levels, which is beneficial for heart health. Additionally, Lactobacillus plantarum 299v has been shown to improve gut health and reduce inflammation, which may indirectly support heart function. ^{1 2 3 4 5}

Is Lactobacillus plantarum 299v safe for human consumption?

Lactobacillus plantarum 299v is considered safe for human consumption, as it has been studied in over 60 human clinical trials and does not confer antibiotic resistance. It is used in various food applications and dietary supplements, showing benefits primarily for gastrointestinal health. ^{4 5 6 7 8}

How is the probiotic treatment Lactobacillus Plantarum 299v unique for heart failure?

Lactobacillus Plantarum 299v is unique because it is a probiotic that may help improve heart health by regulating metabolism, lowering blood pressure, and reducing cholesterol levels, unlike traditional heart failure treatments that typically focus on medication to manage symptoms. ^{1 2 9 10 11}

Research Team

Michael E Widlansky

Principal Investigator

Medical College of Wisconsin

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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]

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]

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]

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]

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]

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]

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]

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]

References

1. Korea (South) pubmed.ncbi.nlm.nih.gov

Effect of Lactobacillus plantarum LMT1-48 on Body Fat in Overweight Subjects: A Randomized, Double-Blind, Placebo-Controlled Trial. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Cholesterol-lowering efficacy of Lactobacillus plantarum CECT 7527, 7528 and 7529 in hypercholesterolaemic adults. [2013]

3. United States 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. [2020]

4. Italy 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. [2021]

5. Poland pubmed.ncbi.nlm.nih.gov

The role of Lactobacillus plantarum 299v in supporting treatment of selected diseases. [2021]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Lactiplantibacillus plantarum 299v (LP299V®): three decades of research. [2021]

7. United States 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). [2021]

8. England pubmed.ncbi.nlm.nih.gov

Probiotic therapy fails to improve gut permeability in a hapten model of colitis. [2019]

9. Russia (Federation) 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]. [2012]

10. Canada pubmed.ncbi.nlm.nih.gov

Progression of Lactobacillus plantarum prosthetic valve endocarditis followed by transesophageal echocardiogram. [2020]

11. Switzerland pubmed.ncbi.nlm.nih.gov

The Mechanisms of the Potential Probiotic Lactiplantibacillus plantarum against Cardiovascular Disease and the Recent Developments in its Fermented Foods. [2022]