Status:
ENROLLING_BY_INVITATION
Evaluating the Effects of a Fermented Diet on Microbiome Diversity in Individuals With Long COVID
Lead Sponsor:
Mayo Clinic
Conditions:
Long COVID
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the effects of fermented foods on bacterial gut microbiome diversity of long-COVID subjects.
Detailed Description
This will be a single-center, longitudinal randomized controlled trial assessing a high fermented food diet intervention among patients with long COVID. The investigators will adapt the high fermente...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 5 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06560554
Start Date
September 5 2024
End Date
April 30 2026
Last Update
December 3 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Mayo Clinic
Rochester, Minnesota, United States, 55904