A Study of Healthy Microbiome, Healthy Mind

NCT06020703 | Recruiting

• 1 other identifier: 23-005057
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Researchers are doing this study to find out if a high fermented food diet is tolerable, and if it will help improve quality of life after surviving a critical illness, including severe COVID-19, by promoting gut health recovery and decreasing gut inflammation.

Conditions

Critical Illness; COVID-19; PICS; Cognitive Impairment; Mental Health Impairment; Weakness, Muscle; Dysbiosis

Outcome Measures

Primary Outcomes (2)

• Feasibility of high fermented food diet among critical illness survivors

  20 critical illness survivors assigned to the intervention arm will tolerate high fermented food diet on 75% of the study days or more

  12 weeks

• gut microbiome diversity

  assessed using Shannon index

  Baseline, 12 weeks

Secondary Outcomes (5)

• Change in inflammatory cytokines

  Baseline, 12 weeks

• Symptoms of anxiety and depression

  Baseline, 12 weeks

• Cognitive Assessment

  Baseline, 12 weeks

• Self-Reported quality of life

  Baseline, 12 weeks

• symptoms of acute stress/PTSD

  Baseline, 12 weeks

Study Arms (2)

Fermented Foods Diet

EXPERIMENTAL

Subjects will incorporate fermented food into their diet.

Behavioral: Fermented Food Diet

Normal Diet

NO INTERVENTION

Subjects will continue their regular diet.

Interventions

Fermented Food Diet BEHAVIORAL

Subjects will incorporate 1 serving of fermented food a day and increase to 6 more each day as tolerated for 4 weeks. After the initial 4 weeks, subjects will eat 6 or more servings of fermented foods each day for 8 weeks.

Fermented Foods Diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- patients who have survived critical illness, including severe COVID, and are at risk for mental health morbidity/long COVID (spent \>48 hours in the ICU or had COVID requiring ICU stay) who have a smartphone, are enrolled into the Mayo PICS clinic, and have at least one PICS-related impairment. Cognitive impairment, if present, has to be in the mild range to ensure patient can provide consent and follow study instructions

You may not qualify if:

• \- History of dementia, mental retardation, psychotic disorders such as schizophrenia, patients not expected to survive the hospital stay or non-English speaking, participants not able to tolerate foods by mouth or those with potential contraindications to such diet (chronically immunosuppressed including organ transplant recipients; those with neutropenia or currently undergoing chemotherapy, those taking Monoamine oxidase inhibitors).

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Minnesota

Rochester, Minnesota, 55905, United States

RECRUITING

MeSH Terms

Conditions

Critical Illness; COVID-19; Cognitive Dysfunction; Muscle Weakness; Dysbiosis

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Study Officials

• Lioudmila Karnatovskaia, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 23, 2023
• First Posted: September 1, 2023
• Study Start: February 26, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)