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

40 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the effects of fermented foods on bacterial gut microbiome diversity of long-COVID subjects.

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 data supports the effectiveness of fermented foods as a treatment 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 inflammation, and increasing energy levels. In a study, patients taking these fermented supplements experienced significant improvements in symptoms compared to those who did not. ^{1 2 3 4 5}

Are fermented foods safe for human consumption?

Fermented foods have been consumed for thousands of years and are generally considered safe for human consumption. They are known to offer health benefits, including boosting the immune system, and have been studied for their potential to help manage infections, including COVID-19. ^{2 6 7 8 9}

How do fermented foods differ from other treatments for post-COVID syndrome?

Fermented foods are unique in treating post-COVID syndrome because they use natural ingredients like Carica papaya and Morinda citrifolia to boost the immune system, reduce inflammation, and balance the body's redox state (a chemical process that affects energy and cell health). Unlike conventional drugs, they work by enhancing the body's natural defenses and energy levels without altering the microbiota in the mouth and throat. ^{1 2 6 8 9}

Research Team

Liousmila V Karnatovskaia, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Fermented Carica papaya and Morinda citrifolia as Perspective Food Supplements for the Treatment of Post-COVID Symptoms: Randomized Placebo-Controlled Clinical Laboratory Study. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Nutritional Modulation of Gut Microbiota Alleviates Severe Gastrointestinal Symptoms in a Patient with Post-Acute COVID-19 Syndrome. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Effect of an Immune-Boosting, Antioxidant and Anti-Inflammatory Food Supplement in Hospitalized COVID-19 Patients: A Prospective Randomized Pilot Study. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Impact of COVID-19 Infection and Persistent Lingering Symptoms on Patient Reported Indicators of Nutritional Risk and Malnutrition. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Dietary Recommendations for Post-COVID-19 Syndrome. [2022]

6. England pubmed.ncbi.nlm.nih.gov

A comprehensive assessment of the antimicrobial and immunomodulatory effects of frequently consumed fermented foods: insights in the management of COVID-19. [2023]

7. England pubmed.ncbi.nlm.nih.gov

The International Scientific Association for Probiotics and Prebiotics (ISAPP) consensus statement on fermented foods. [2021]

8. India pubmed.ncbi.nlm.nih.gov

Bioactive metabolites in functional and fermented foods and their role as immunity booster and anti-viral innate mechanisms. [2023]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Protective effects elicited by cow milk fermented with L. Paracasei CBAL74 against SARS-CoV-2 infection in human enterocytes. [2022]