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

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT06560554
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

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

Study Details

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

Key Dates

Start date
Sep 5, 2024
Status verified
Jun 2026
Primary completion
Sep 30, 2025
Completion
Dec 30, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Control
    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.
  • Experimental: Treatment
    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.

Primary Outcome Measure

Gut Microbiome diversity [ Time Frame: At enrollment and completion of study (12 weeks) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo ClinicRochesterMinnesota55904-

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