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Fermented Food Diet for Microbiome Balance

N/A
Recruiting
Led By Lioudmila 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
Cognitive impairment, if present, has to be in the mild range to ensure patient can provide consent and follow study instructions
Be older than 18 years old
Must not have
Non-English speaking
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial tests if a high fermented food diet can help those who have been critically ill, incl. those with severe COVID-19, to improve their gut health and reduce inflammation.

Who is the study for?
This trial is for people who've been critically ill, including severe COVID-19 cases, and spent time in the ICU. They should be at risk of long-term mental health issues but can't have dementia or severe cognitive impairment. Participants must speak English, eat normally, not be severely immunosuppressed or on certain medications like MAO inhibitors.
What is being tested?
The study tests if a diet rich in fermented foods can improve life quality after critical illness by aiding gut health and reducing inflammation. It's aimed at those recovering from serious conditions such as COVID-19 to see if this dietary change could help with physical and mental recovery.
What are the potential side effects?
While specific side effects are not listed for a fermented food diet, potential issues may include digestive discomfort such as bloating or gas due to increased fiber and probiotic content in these types of foods.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cognitive function is good enough to understand and follow study instructions.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not speak English.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Feasibility of high fermented food diet among critical illness survivors
gut microbiome diversity
Secondary study objectives
Change in inflammatory cytokines
Cognitive Assessment
Self-Reported quality of life
+2 more

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: Fermented Foods DietExperimental Treatment1 Intervention
Subjects will incorporate fermented food into their diet.
Group II: Normal DietActive Control1 Intervention
Subjects will continue their regular diet.

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,360 Previous Clinical Trials
3,065,901 Total Patients Enrolled
17 Trials studying Critical Illness
42,659 Patients Enrolled for Critical Illness
Lioudmila Karnatovskaia, MDPrincipal InvestigatorMayo Clinic
2 Previous Clinical Trials
354 Total Patients Enrolled
1 Trials studying Critical Illness
54 Patients Enrolled for Critical Illness
~9 spots leftby Apr 2025
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