What side effects are associated with this type of intervention?

Common treatments for COVID-19 include multi-nutrient, herbal, and probiotic therapies. Probiotics like Lactobacillus plantarum 299v are generally well-tolerated but can cause mild gastrointestinal symptoms such as bloating, gas, and diarrhea. Other treatments, such as high-dose zinc, may cause nausea, a metallic taste, and gastrointestinal discomfort. It is important to consult with a healthcare provider to tailor treatments to individual needs and monitor for any adverse effects.

What prior FDA approvals exist?

The FDA has granted Emergency Use Authorization (EUA) for several treatments for COVID-19, including monoclonal antibodies like bebtelovimab, which target specific proteins of the virus to prevent its spread. Additionally, tocilizumab, an IL-6 pathway inhibitor, has been used to reduce inflammation and prevent progression to severe disease. While Lactobacillus plantarum 299v is being studied for its potential to reduce inflammation and improve vascular function by modulating the gut microbiome, similar immune-modulating treatments like corticosteroids and other anti-inflammatory agents have been part of the COVID-19 treatment landscape.

What other types of research exist?

Promising alternatives to Lactobacillus plantarum 299v for COVID-19 patients include: 1) Heat-killed Lactobacillus plantarum L-137 (HK L-137), which has shown improvements in inflammation and lipid metabolism. 2) Lactobacillus gasseri, which has demonstrated benefits in reducing clinical severity of asthma and allergic rhinitis, potentially aiding respiratory health. 3) Synbiotics combining probiotics like Bifidobacterium breve with prebiotics, which have shown efficacy in reducing inflammation and improving immune responses in allergic conditions.

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Probiotic

Probiotics for Long COVID Symptoms

N/A

Recruiting

Led By Michael E Widlansky, MD, MPH

Research Sponsored by Medical College of Wisconsin

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ages 18 to 89 years

Be older than 18 years old

Must not have

Subjects currently taking Vitamin K antagonists such as coumadin or warfarin

History of cognitive impairment/inability to follow study procedures

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks

Summary

This trial tests whether taking a probiotic called Lp299v can help people who have long-term symptoms after COVID-19. The probiotic aims to reduce inflammation and improve blood vessel function. Adults aged 18-89 with these symptoms will take the supplement for a period of time to see if it helps. Probiotics have shown benefits in a variety of diseases, including respiratory infections, and may be beneficial in the adjunctive treatment of COVID-19.

Who is the study for?

This trial is for adults aged 18-89 who have had COVID-19 and are experiencing lingering symptoms known as PASC. They must be within 30 to 180 days post-diagnosis. People with daily alcohol use, recent antibiotics, blood thinner usage like warfarin, pregnancy, cognitive issues preventing study compliance, unstable heart disease or certain chronic conditions can't participate.

What is being tested?

The trial tests if a probiotic called Lactobacillus plantarum (Lp299v) in capsule form can improve blood vessel function in those with PASC by reducing inflammation and immune system activation compared to a placebo made of potato starch capsules.

What are the potential side effects?

While the specific side effects aren't listed here, probiotics like Lp299v typically may cause digestive discomfort such as gas or bloating. Placebos generally have no active ingredients but can sometimes cause mild reactions due to psychological factors.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 89 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently taking blood thinners like coumadin or warfarin.

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I have no history of cognitive issues affecting my ability to follow study instructions.

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I have short gut syndrome, inflammatory bowel disease, or an ileostomy.

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I haven't had chronic kidney, liver diseases, or cancer treatments in the last 3 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Brachial Artery Flow Mediated Dilation (FMD%)

Secondary study objectives

Brachial Artery Resting Diameter

Carotid-Femoral Pulse Wave Velocity (cfPWV)

Cell-Free Mitochondrial DNA (cf-mtDNA)

+7 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Lp299vExperimental Treatment1 Intervention

Subjects will consume 20 billion colony forming units of Lp299v (2 capsules) once daily for 8 weeks.

Group II: Heat-killed placebo controlPlacebo Group1 Intervention

Subjects will consume potato starch (2 capsules) once daily for 8 weeks.

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for COVID-19 often target viral replication, inflammation, and immune modulation. For example, Lactobacillus plantarum 299v, a probiotic, reduces circulating cell-free mitochondrial DNA (cf-mtDNA), decreases toll-like receptor 9 (TLR9) activation, and lowers inflammation. These actions are crucial because they help mitigate the excessive inflammatory response and endothelial dysfunction associated with COVID-19, potentially improving patient outcomes and reducing complications.

A naturopathic treatment approach for mild and moderate COVID-19: A retrospective chart review.The effect of probiotics on respiratory tract infection with special emphasis on COVID-19: Systemic review 2010-20.Effects of Probiotics in Conditions or Infections Similar to COVID-19 on Health Outcomes: An Evidence Analysis Center Scoping Review.