Fermented Foods for Post-COVID Syndrome

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must not be taking: MAOIs

Disqualifiers: Dementia, Immunosuppressed, Chemotherapy, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how fermented foods can improve gut health in people with long COVID symptoms. Researchers aim to determine if these foods can increase the variety of beneficial gut bacteria, potentially alleviating symptoms like fatigue and difficulty concentrating. Participants in the treatment group will learn about and select different probiotic fermented foods, while the control group will maintain their current diet. The trial seeks individuals who have had COVID within the last year and are experiencing neurological symptoms such as fatigue and anxiety. Participants must have visited the Mayo Clinic long-COVID Clinic and own a smart device for tracking their diet. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research on dietary interventions for long COVID.

Do I have to stop taking my current medications for the trial?

The trial requires that you do not take MAOIs (a type of antidepressant) at the time of consent. Other medications are not specifically mentioned, so it's best to discuss your current medications with the trial team.

What prior data suggests that fermented foods are safe for long-COVID subjects?

Research has shown that fermented foods are generally safe to eat. Studies have found that these foods contain beneficial bacteria, like those in yogurt, kimchi, and sauerkraut, which help ensure their safety. This is important for anyone considering adding fermented foods to their diet.

People worldwide consume these foods, and they are usually well-tolerated. They have been part of many diets for a long time, indicating their general safety. While most people handle them well, some might experience mild side effects like bloating or gas. Overall, fermented foods are considered safe for most people, including those recovering from COVID-19. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using fermented foods for post-COVID syndrome because they offer a natural approach to supporting gut health, which is increasingly recognized as vital for overall well-being. Unlike conventional treatments that may involve medications targeting specific symptoms, fermented foods introduce beneficial probiotics that can help restore a balanced microbiome. This approach is appealing as it empowers individuals to make personal dietary choices based on their taste preferences while potentially alleviating various post-COVID symptoms through improved gut health.

What evidence suggests that fermented foods might be an effective treatment for post-COVID syndrome?

This trial will evaluate the effects of fermented foods on post-COVID syndrome. Studies have shown that fermented foods can improve gut health, which is crucial for people with post-COVID syndrome. Research indicates that foods like kimchi, sauerkraut, and certain drinks can strengthen the immune system and lessen post-COVID symptoms. Fermented foods provide probiotics, beneficial bacteria that can heal the gut. Early findings suggest these foods may reduce inflammation and aid recovery in long-COVID patients. Overall, fermented foods could support recovery from post-COVID syndrome by improving gut health. Participants in this trial will receive education on probiotic fermented foods and choose their own based on taste preference, while the control group will maintain their regular diet. ^{1 2 3 5 6}

Who Is on the Research Team?

Liousmila V Karnatovskaia, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults over 18 with long COVID, defined as having had a COVID-19 infection in the last year and experiencing neurological symptoms like fatigue or difficulty concentrating. Participants must have visited the Mayo Clinic's long-COVID Clinic and be able to use a food logging app.

Inclusion Criteria

I am over 18 years old.

I had COVID-19 in the last year and have long COVID symptoms like fatigue or difficulty concentrating.

Own a smart device capable of downloading a food logging application and able to understand and document informed consent

Exclusion Criteria

Reported consumption of 2 servings of probiotic fermented food per day in their normal baseline diet

Pregnancy

Unable to tolerate oral foods

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Participants attend an in-person visit for baseline assessments, including interviews, psychometric evaluations, and installation of the food tracking application.

1 day

1 visit (in-person)

Intervention

Participants in the intervention arm incorporate probiotic fermented foods into their diet, starting with one serving per day and increasing to 6+ servings per day by the end of week 4. Weekly phone calls are conducted to review intake and provide support.

12 weeks

Weekly phone calls (virtual)

Control

Participants in the control arm document their regular diet 3 days a week without dietary changes. They attend baseline and week 13 visits.

12 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the intervention, including collection of stool samples and completion of study questionnaires.

1 week

1 visit (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Fermented foods

Trial Overview The study aims to see if eating fermented foods can change the variety of bacteria in the gut of people with long COVID. Participants will either follow their usual diet (control group) or include fermented foods, and researchers will compare results between these two groups.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

Will receive an in-person teaching session delivered by a trained team member including introductory education on microbiome and a description on a variety of probiotic fermented foods commercially available (fermented dairy products, fermented vegetables, fermented non-alcoholic drinks). Participants will be able to choose their own probiotic fermented foods based on this education and taste preference. Subjects will be contacted weekly to ensure they are tolerating and adhering to the study protocol.

Group II: Control Active Control 1 Intervention

The subjects in the control arm will only complete the baseline and week 13 visits. They will not be asked to make any changes to their diet, only to document their regular diet 3 days a week.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

Nearly half of the 92 participants recovering from COVID-19 were at risk for malnutrition, which was linked to more severe symptoms and lower calorie intake, indicating that persistent malnutrition can hinder recovery.

Most participants failed to meet dietary recommendations for fruits, vegetables, and optimal protein intake, suggesting a critical need for nutritional education and support to improve recovery outcomes after COVID-19.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of COVID-19 Infection and Persistent Lingering Symptoms on Patient Reported Indicators of Nutritional Risk and Malnutrition. Deer, RR., Hosein, E., Harvey, M., et al.[2022]

A 2-month nutritional intervention using a high-fiber formula significantly alleviated gastrointestinal symptoms in a patient with post-acute COVID-19 syndrome, leading to improvements in appetite, anxiety, and medication dosage for nausea.

The intervention resulted in beneficial changes in the patient's gut microbiota, including the increase of short-chain fatty acid-producing bacteria, which may be linked to symptom relief, highlighting the potential of gut microbiota modulation as a therapeutic strategy for post-COVID-19 gastrointestinal issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutritional Modulation of Gut Microbiota Alleviates Severe Gastrointestinal Symptoms in a Patient with Post-Acute COVID-19 Syndrome. Wang, Y., Wu, G., Zhao, L., et al.[2022]

Post-COVID-19 syndrome can lead to malnutrition, loss of muscle mass, and low-grade inflammation, highlighting the need for comprehensive health evaluations for COVID-19 survivors.

Personalized dietary recommendations are crucial for recovery, as they can help address persistent symptoms like fatigue, appetite loss, and psychological distress in patients recovering from COVID-19.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary Recommendations for Post-COVID-19 Syndrome. Barrea, L., Grant, WB., Frias-Toral, E., et al.[2022]

The expert panel defined fermented foods as those made through specific microbial growth and enzymatic processes, aiming to clarify the term 'fermented' and distinguish these foods from probiotics.

The panel highlighted the health benefits and safety of fermented foods, discussing their nutritional value and potential to improve gastrointestinal and overall health, while also advocating for their recognition in national dietary guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The International Scientific Association for Probiotics and Prebiotics (ISAPP) consensus statement on fermented foods. Marco, ML., Sanders, ME., Gänzle, M., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12566607/

The Role of Probiotics and Their Postbiotic Metabolites in Post ... These results suggest that probiotic administration in COVID-19 may have long-term health benefits for recovering patients, as the presence of post-COVID ...

2. withpower.com withpower.com/trial/phase-long-covid-7-2024-9624c

Fermented Foods for Post-COVID Syndrome Research shows that fermented foods like Carica papaya and Morinda citrifolia can help reduce post-COVID symptoms by boosting the immune system, reducing ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2666337625001027

Impact of nutrition on long COVID Effective interventions like supplementation of omega-3 fatty acid, macro and micro nutrients, and vitamins help to reduce systemic inflammation ...

4. reaganudall.org reaganudall.org/clinical-trial/evaluating-effects-fermented-diet-microbiome-diversity-individuals-long-covid

Evaluating the Effects of a Fermented Diet on Microbiome The purpose of this study is to evaluate the effects of fermented foods on bacterial gutmicrobiome diversity of long-COVID subjects.

5. ifm.org ifm.org/articles/exploring-the-link-between-covid-19-gut-microbiota

Exploring the Link Between COVID-19 & Gut Microbiota Kimchi, sauerkraut, and pickles in glass containers shows probiotic rich foods as a therapeutic interventions which may heal the gut microbiome and diminish ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2772502225004056

Bioactive compounds in fermented foods: Health benefits ... Fermented foods with high acidity, salt, or alcohol content have a strong safety record (Jeon et al., 2015). Lactic acid bacteria (LAB) enhance safety by ...