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Active Not Recruiting
NCT06020703
A Study of Healthy Microbiome, Healthy Mind
Conditions: Critical Illness, COVID-19, PICS, Cognitive Impairment, Mental Health Impairment, Weakness, Muscle, Dysbiosis
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 40
Sponsor: Mayo Clinic
Location: Mayo Clinic Minnesota Rochester Minnesota
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.
Eligibility Criteria
Inclusion Criteria:
\- 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 Criteria:
\- 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).
Source: ClinicalTrials.gov (NCT06020703). StuddyBuddy aggregates publicly available trial information.
