RecruitingNot ApplicableNCT06020703

A Study of Healthy Microbiome, Healthy Mind

Healthy Microbiome, Healthy Mind: Using Gut-brain Axis for Improving Psychocognitive Health Outcomes of Critical Illness Survivors


Sponsor

Mayo Clinic

Enrollment

40 participants

Start Date

Feb 26, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria1

  • \- 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 Criteria1

  • \- 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).

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Interventions

BEHAVIORALFermented Food Diet

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.


Locations(1)

Mayo Clinic Minnesota

Rochester, Minnesota, United States

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NCT06020703


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