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Search / Trial NCT06020703

A Study of Healthy Microbiome, Healthy Mind

Launched by MAYO CLINIC · Aug 28, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial, titled "A Study of Healthy Microbiome, Healthy Mind," is looking at whether eating a diet rich in fermented foods can help improve the quality of life for people who have survived serious illnesses, including severe COVID-19. The researchers believe that this diet might support gut health and reduce inflammation in the gut, which could lead to better mental and physical well-being after experiencing critical illness.

To be eligible for this study, participants need to be between the ages of 65 and 74, have survived a critical illness (like severe COVID-19) and spent at least 48 hours in the ICU, and have some mild cognitive or mental health issues. They should also have a smartphone and be enrolled in the Mayo PICS clinic. Throughout the trial, participants will follow a specially designed diet and provide feedback on how they feel. It’s important to note that individuals with certain serious health conditions or who cannot tolerate food by mouth are not eligible to join the study.

Gender

ALL

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).

About Mayo Clinic

Mayo Clinic is a renowned nonprofit medical practice and research institution dedicated to providing comprehensive healthcare and advancing medical knowledge through innovative research and education. With a commitment to patient-centered care, Mayo Clinic conducts numerous clinical trials aimed at exploring new therapies and improving treatment outcomes across various disciplines. Leveraging a multidisciplinary approach, the institution collaborates with leading experts and cutting-edge technology to ensure rigorous scientific standards and ethical practices in all its research endeavors. Through its trials, Mayo Clinic seeks to translate breakthroughs in science into tangible benefits for patients, fostering advancements in medicine that enhance health and quality of life.

Locations

Rochester, Minnesota, United States

Patients applied

0 patients applied

Trial Officials

Lioudmila Karnatovskaia, MD

Principal Investigator

Mayo Clinic

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported