Evaluating the Effects of a Fermented Diet on Microbiome Diversity in Individuals With Long COVID (NCT06560554) | Clinical Trial Compass
By InvitationNot Applicable
Evaluating the Effects of a Fermented Diet on Microbiome Diversity in Individuals With Long COVID
United States40 participantsStarted 2024-09-05
Plain-language summary
The purpose of this study is to evaluate the effects of fermented foods on bacterial gut microbiome diversity of long-COVID subjects.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Adult (\> 18 years old)
. Patients who have long COVID symptoms
. 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 criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is focused on changing the diet — specifically eating fermented foods — to affect gut bacteria in Long COVID patients. Do you think my current gut health or digestive symptoms make me a good or poor candidate for this kind of approach?
2Since this trial is 'enrolling by invitation,' how would someone actually get considered for it, and is this something you could help facilitate or refer me toward?
3The trial is measuring gut microbiome diversity as its main outcome, but not directly measuring Long COVID symptom improvement — so how confident should I be that changes in my microbiome would actually translate into feeling better?
4This study doesn't have a traditional phase like Phase 1 or Phase 2, which suggests it may be more exploratory research — what does that mean for how much is already known about whether a fermented diet is safe and helpful for people with Long COVID?
5Before exploring a trial like this, should I try any standard or established treatments for Long COVID first, or is a dietary approach like this something that could realistically run alongside other care I'm already receiving?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Gut Microbiome diversity
Timeframe: At enrollment and completion of study (12 weeks)