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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Feasibility of high fermented food diet among critical illness survivors

gut microbiome diversity

Secondary outcome measures

Change in inflammatory cytokines

Cognitive Assessment

Self-Reported quality of life

+2 more

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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,213 Previous Clinical Trials

3,766,971 Total Patients Enrolled

Lioudmila Karnatovskaia, MDPrincipal InvestigatorMayo Clinic

2 Previous Clinical Trials

354 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there vacancies available for enrollment in this clinical trial?

"Clinicaltrials.gov denotes that this study, which originally appeared on October 2nd 2023 and was last modified September 8th 2023, is not actively looking for patients at the moment. Nevertheless, 759 other clinical trials are currently recruiting volunteers right now."

Answered by AI

What is the main aim of this experiment?

"This 12-week trial aims to evaluate and assess gut microbiome diversity. Other objectives include measuring the level of anxiety, depression, cognitive ability and self-reported quality of life amongst participants. The Hospital Anxiety and Depression Scale (HADS) will be used for emotional state evaluation; comprising 14 questions with a score range from 0 to 21 per subscale - 0 – 7 representing normal levels while 8 - 10 indicating borderling abnormal mental health states. Similarly, the Montreal Cognitive Assessment (MoCA-BLIND) test is employed for assessing cognition over 13 tasks with summing up all five sections' scores resulting in an overall maximum achievable value of 22"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Healthy Microbiome, Healthy Mind

Lioudmila Karnatovskaia 2024. "A Study of Healthy Microbiome, Healthy Mind". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06020703.