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Probiotics
Fermented Foods for Post-COVID Syndrome
Rochester, MN
N/A
Waitlist Available
Led By Liousmila V Karnatovskaia, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adults (>18 years old)
Be older than 18 years old
Must not have
Undergoing chemotherapy at the time of consent
Taking MAOIs at the time of consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at enrollment and completion of study (12 weeks)
Awards & highlights
No Placebo-Only Group
Summary
"This trial aims to see how eating fermented foods affects the variety of bacteria in the gut of people with long-COVID."
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Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While not explicitly listed, potential side effects may include digestive discomfort due to changes in diet when introducing fermented foods, such as bloating, gas, or altered bowel movements.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am over 18 years old.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently receiving chemotherapy.
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I am currently taking MAOI medications.
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I do not have active, severe digestive system conditions or recent major GI surgery.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at enrollment and completion of study (12 weeks)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at enrollment and completion of study (12 weeks)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Gut Microbiome diversity
Secondary study objectives
Assessment of cognition
Assessment of post-traumatic stress (PTSD) symptoms
Assessment of quality of life
+1 moreOther study objectives
Research participant's subjective assessment of study adherence
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: TreatmentExperimental Treatment1 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: ControlActive Control1 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.
Find a Location
Closest Location:Mayo Clinic· Rochester, MN· 562 miles
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,414 Previous Clinical Trials
3,209,149 Total Patients Enrolled
30 Trials studying COVID-19
232,429 Patients Enrolled for COVID-19
Liousmila V Karnatovskaia, MDPrincipal InvestigatorMayo Clinic