Probiotics for Cardiovascular Health

(OPEDNPN Trial)

Overseen By Jeanie Baird, MPA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University

Must not be taking: Anticoagulants, Antiplatelets

Disqualifiers: Autoimmune diseases, Pregnancy, others

Compensation: Varies

Number of Visits: 2

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether the probiotic Herbiotics Oral + Ent Probiotic affects the body's ability to produce nitric oxide (NO), a molecule crucial for healthy blood flow. By examining how this probiotic interacts with the natural process of converting food into NO, researchers aim to understand its impact on heart health. Participants will take either the probiotic or a placebo (a harmless sugar pill) for a week and consume beetroot juice to measure changes in NO production. Healthy adults without dry mouth or recent dental issues may be suitable for this trial. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research on heart health.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on anti-coagulant or anti-platelet therapy like aspirin or Coumadin.

What prior data suggests that this probiotic is safe for cardiovascular health?

Research has shown that probiotics, such as Herbiotics Oral + Ent Probiotic, are generally safe and easy to tolerate. These probiotics support gut and mouth health and are safe for both adults and children when used as directed.

The trial under consideration does not focus on treating a disease. Instead, it examines how the probiotic affects the body's natural process of converting dietary nitrate (found in foods like leafy greens) into nitrite and then into nitric oxide, which is important for heart health. Studies have not reported any major side effects with this probiotic, indicating it is well-tolerated.

However, since individual reactions can vary, consulting a healthcare provider before joining any trial is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Herbiotics Oral + Ent Probiotic for cardiovascular health because it offers a unique approach compared to traditional treatments like statins or beta-blockers. Unlike these medications, which directly alter cholesterol levels or blood pressure, this probiotic aims to improve heart health by promoting a balanced gut microbiome, which is increasingly recognized for its role in cardiovascular wellness. Additionally, the probiotic is administered as a lozenge, offering a convenient and potentially more pleasant delivery method than pills or injections. This innovative approach could complement existing therapies and provide a natural alternative for maintaining heart health.

What evidence suggests that this probiotic could affect cardiovascular health?

Research suggests that probiotics, such as Herbiotics Oral + Ent Probiotic, which participants in this trial may receive, might aid heart health. Some studies have found that probiotics could improve heart health by reducing the size of a heart attack. They may also support better blood flow by enhancing the body's process involving nitrates and nitrites, crucial for heart health. However, this probiotic might affect the body's conversion of dietary nitrate to nitrite, potentially influencing its effectiveness. More research is needed to fully understand how these probiotics impact heart health. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 18-70 who may be interested in how a probiotic affects heart health. It's not for treating any disease but to understand the body's production of an important molecule, Nitric Oxide (NO), from dietary sources.

Inclusion Criteria

I am a healthy adult between 18 and 70 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline

Participants provide baseline saliva, tongue, and blood samples before consuming beetroot juice. They are then given either a probiotic or placebo for 7 days.

1 week

1 visit (in-person)

Follow-up

Participants return for follow-up to provide saliva, tongue, and blood samples after 7 days of probiotic or placebo consumption.

1 day

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Herbiotics Oral + Ent Probiotic

Trial Overview The study tests if taking a specific oral probiotic changes how well the body converts dietary nitrate (found in veggies like beetroot) into nitrite and then NO, which is crucial for blood flow and cardiovascular health.

How Is the Trial Designed?

Group I: Probiotic Active Control 1 Intervention

Participants will take the commercially available oral probiotic (Herbiotics Oral + Ent Probiotic) twice a day for 7 days as instructed by the manufacturer. This entails one lozenge twice a day taken by mouth and slowly chewed or allowed to melt in the mouth.

Group II: Placebo Placebo Group 2 Interventions

Participants will take the commercially available Honest Placebo Pills by Zeebo twice a day for 7 days. This entails one tablet twice a day taken by mouth and slowly chewed or allowed to melt in the mouth.

Who Is Running the Clinical Trial?

Wake Forest University

Lead Sponsor

Trials

193

Recruited

151,000+

University of South Florida

Collaborator

Trials

433

Recruited

198,000+

Published Research Related to This Trial

Probiotics, including Lactobacilli and bifidobacteria, are generally considered safe for human consumption, with rare cases of serious infections like bacteremia reported but no significant increase in risk observed in the general population.

Controlled clinical trials have shown that probiotics can be used safely, and it is recommended that their use in trials be monitored by a data-safety board to ensure participant safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety of probiotics. Snydman, DR.[2022]

Probiotics are widely used, with over 20 billion doses taken annually, and are generally considered safe with very few serious side effects reported.

There is a need for standardized criteria to define what qualifies as a 'probiotic' to ensure products meet safety and efficacy standards, especially as new products enter the market.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safe and efficacious probiotics: what are they? Reid, G.[2007]

Probiotic supplementation significantly reduced systolic blood pressure (SBP) by 2.05 mmHg and diastolic blood pressure (DBP) by 1.26 mmHg in patients with hypertension, based on a meta-analysis of 14 studies involving 846 participants.

In addition to lowering blood pressure, probiotics also led to a reduction in body mass index (BMI) by 1.03 and blood glucose levels by 0.18 mmol/L, indicating their potential benefits for overall metabolic health, especially in individuals with diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Probiotics on Patients with Hypertension: a Systematic Review and Meta-Analysis. Chi, C., Li, C., Wu, D., et al.[2022]

Certain probiotic bacteria, especially Lactobacillus and Bifidobacterium, may help improve oral health by inhibiting harmful bacteria like cariogenic streptococci and Candida, based on recent studies and trials.

Probiotics work through mechanisms such as immune modulation and the production of antimicrobial substances, but more research is needed to fully understand their effects in the oral cavity and their potential role in combating antimicrobial resistance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Probiotics: do they have a role in oral medicine and dentistry? Meurman, JH.[2022]

Probiotics, defined as live microorganisms that provide health benefits when consumed in adequate amounts, have been traditionally used in fermented dairy products and show potential for medical nutrition therapy.

A comprehensive literature review identified various medical conditions, such as diarrhea, irritable bowel syndrome, and inflammatory bowel disease, that may benefit from probiotic treatment, highlighting the need for further research on their efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Probiotics and medical nutrition therapy. Brown, AC., Valiere, A.[2022]

In a rat model of systemic inflammatory response syndrome (SIRS), probiotics Lactobacillus acidophilus (LA-5) and Bifidobacterium animalis subsp. lactis (BB-12) significantly reduced myocardial infarction size, suggesting a protective effect against ischemic-reperfusion injury.

The treatment with these probiotics also normalized various inflammatory and immune parameters, indicating their potential to improve cardiovascular health in the context of metabolic and inflammatory disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Probiotic Strains on Myocardial Infarction Size, Biochemical and Immunological Parameters in Rats with Systemic Inflammatory Response Syndrome and Polymorbidity. Borshchev, YY., Sonin, DL., Burovenko, IY., et al.[2023]

Probiotics, while generally considered safe, can pose significant risks including systemic infections, gastrointestinal issues, and immune system stimulation, particularly in vulnerable populations such as infants, the elderly, and immunocompromised individuals.

The review highlights the need for careful evaluation of the risk-benefit ratio of probiotics before recommending their use, given the variety of adverse effects reported across different studies and case reports.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reappraisal of probiotics' safety in human. Sotoudegan, F., Daniali, M., Hassani, S., et al.[2019]

Atherosclerosis is a major cause of cardiovascular diseases and global mortality, and current treatments primarily targeting dyslipidemia have significant limitations and side effects.

Recent interest in probiotics as nutraceuticals suggests they may help prevent atherosclerosis and could be used alongside existing medications, with ongoing research into their anti-atherogenic effects and mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Potential of Probiotics in the Prevention and Treatment of Atherosclerosis. O'Morain, VL., Ramji, DP.[2021]

Probiotic bacteria can provide health benefits when consumed in adequate amounts, and their effects vary based on specific strains, which can lead to different health claims.

An international expert group has identified key areas for probiotic application, including metabolism, intestinal disorders, infections, and allergies, and emphasized the need for standardized guidelines to assess their efficacy and characteristics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guidance for substantiating the evidence for beneficial effects of probiotics: current status and recommendations for future research. Rijkers, GT., Bengmark, S., Enck, P., et al.[2023]

Probiotics, which are live microorganisms that can provide health benefits when consumed in adequate amounts, have shown effectiveness in preventing and treating various health conditions, including lactose intolerance, diarrhea (from different causes), and infections like Clostridium difficile.

Recent studies indicate that probiotics may also play a role in managing irritable bowel syndrome, inflammatory bowel diseases, and even in preventing allergic diseases and respiratory infections, highlighting their potential as a versatile therapeutic option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Probiotics. A review]. Giorgi, PL.[2020]

Citations

1. withpower.com withpower.com/trial/probiotics-for-cardiovascular-health-4474c

Probiotics for Cardiovascular Health (OPEDNPN Trial) Research suggests that probiotics, including strains like Lactobacillus and Bifidobacterium, may help reduce heart attack size and improve heart health in ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06375694

Probiotic Effect on Dietary Nitrate to Plasma Nitrite ... The primary hypothesis of this study is that participants that consume the probiotic will have lower nitrate to nitrite conversion at follow-up compared to ...

3. herobiotics.com herobiotics.com/

Herobiotics: Your Partner for Dental Probiotics & Oral Wellness While more studies are still needed to uncover the exact link between oral health and heart health, we believe that taking Herobiotics Oral + ENT Probiotic ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12231435/

The beneficial effects of probiotics on patients with ... Probiotics, particularly monotherapy for LDL and combination therapy for HDL, exhibited potential to improve lipid profiles in CHD patients.

5. sciencedirect.com sciencedirect.com/science/article/pii/S1756464620302097

A critical appraisal of the effects of probiotics on oral health Recent studies including clinical trials strongly suggest the active role of probiotics in prevention and treatment of oral infections.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40093880/

Association of probiotic supplementation and ... Our study reinforces the beneficial association between probiotic ingestion and cardiovascular health in patients with existing atherosclerotic disease.

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06375694/probiotic-effect-on-dietary-nitrate-to-plasma-nitrite-production-opednpn

Probiotic Effect on Dietary Nitrate to Plasma Nitrite ... Emerging studies suggest that the Nitrate-Nitrite-NO cycle may contribute to cardiovascular health. In addition, there have been many studies ...