Status:
RECRUITING
A Study of Healthy Microbiome, Healthy Mind
Lead Sponsor:
Mayo Clinic
Conditions:
Critical Illness
COVID-19
Eligibility:
All Genders
18+ years
Phase:
NA
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 p...
Detailed Description
Critical illness, including severe COVID, often lead to long term cognitive and mental health complications. Current non-pharmacological interventions, including ABCDEF bundle, are of limited efficacy...
Eligibility Criteria
Inclusion
- \- 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
Exclusion
- \- 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).
Key Trial Info
Start Date :
February 26 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06020703
Start Date
February 26 2024
End Date
December 1 2026
Last Update
January 8 2026
Active Locations (1)
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1
Mayo Clinic Minnesota
Rochester, Minnesota, United States, 55905