NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

A Study of Healthy Microbiome, Healthy Mind

NCT06020703

Active Not RecruitingNA

Sponsor: Mayo Clinic

Conditions: Critical Illness, COVID-19, PICS, Cognitive Impairment, Mental Health Impairment

Interventions: Fermented Food Diet

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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).

Locations (1)

Rochester, Minnesota, United States