Evaluating the Effects of a Fermented Diet on Microbiome Diversity in Individuals With Long COVID

NCT06560554 | Enrolling By Invitation

• 1 other identifier: 24-005170
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Long COVID

Keywords

Long COVID; anxiety; depression; gut microbiome; fermented foods

Outcome Measures

Primary Outcomes (1)

• Gut Microbiome diversity

  High-dimensional microbiome data representing taxonomic features of the microbiomes will be analyzed to decode the community structure and key components that are associated with the condition of interest

  At enrollment and completion of study (12 weeks)

Secondary Outcomes (4)

• Symptoms of depression and anxiety

  At enrollment and completion of study (12 weeks)

• Assessment of cognition

  At enrollment and completion of study (12 weeks)

• Assessment of quality of life

  At enrollment and completion of study (12 weeks)

• Assessment of post-traumatic stress (PTSD) symptoms

  At enrollment and completion of the study (12 weeks)

Other Outcomes (1)

• Research participant's subjective assessment of study adherence

  At enrollment and weekly, through completion of the study (12 weeks)

Study Arms (2)

Control

ACTIVE COMPARATOR

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.

Other: Control

Treatment

EXPERIMENTAL

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.

Other: Fermented foods

Interventions

Fermented foods OTHER

Participants randomized to the intervention arm will begin to incorporate probiotic fermented foods into their diet during weeks 1-4 of the study (ramp up phase). They will start with one serving of fermented food of their choice a day, increasing to 6+/day as tolerated by the end of week 4. Weeks 5-12 will serve as the intervention maintenance phase, with the target of a daily intake of 6+ servings of fermented foods.

Treatment

Control OTHER

No information on incorporation of fermented foods will be provided for subjects in the control arm.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (\> 18 years old)
• Patients who have long COVID symptoms
• a. Long COVID will be defined as: i. A previously documented COVID + infection within the last year ii. A presence of neurological symptoms that started within 4 weeks of the COVID infection (fatigue, difficulty concentrating, depression, anxiety) as per CDC definition of Long Covid.
• Own a smart device capable of downloading a food logging application. Able to understand and document informed consent
• Seen in the Mayo Clinic long-COVID Clinic within the Department of General Internal Medicine

You may not qualify if:

• History of dementia, moderate or severe cognitive dysfunction, developmental delay, psychotic disorders such as schizophrenia
• Unable to tolerate oral foods
• Potential contraindications to a fermented food diet (chronically immunosuppressed including organ transplant recipients)
• Neutropenic as listed in the "active problems" list in the EMR
• Undergoing chemotherapy at the time of consent
• Taking MAOIs at the time of consent.
• Active uncontrolled inflammatory bowel disease including ulcerative colitis, Crohn's disease, indeterminate colitis, irritable bowel syndrome (moderate or severe), infectious gastroenteritis, colitis or gastritis, Clostridium difficile infection (recurrent), malabsorptive diseases (such as Celiac disease), major surgery of the GI tract with the exception of cholecystectomy and/or appendectomy in the past 5 years, or any major bowel resection at any time.
• A reported consumption of 2 servings of probiotic fermented food per day in their normal baseline diet.
• Pregnancy

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55904, United States

Location

Related Publications (1)

• Wastyk HC, Fragiadakis GK, Perelman D, Dahan D, Merrill BD, Yu FB, Topf M, Gonzalez CG, Van Treuren W, Han S, Robinson JL, Elias JE, Sonnenburg ED, Gardner CD, Sonnenburg JL. Gut-microbiota-targeted diets modulate human immune status. Cell. 2021 Aug 5;184(16):4137-4153.e14. doi: 10.1016/j.cell.2021.06.019. Epub 2021 Jul 12.

  PMID: 34256014 BACKGROUND

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; Anxiety Disorders; Depression

Interventions

Fermented Foods

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Liousmila V Karnatovskaia, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants who are randomized to the control group will not be given information on increasing fermented foods
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Single center, longitudinal, randomized trial

Study Record Dates

• First Submitted: August 9, 2024
• First Posted: August 19, 2024
• Study Start: September 5, 2024
• Primary Completion: September 30, 2025
• Study Completion: April 30, 2026
• Last Updated: December 3, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)