Exploring the effects of a fermented food diet on mental health after critical illness
Healthy Microbiome, Healthy Mind: Using Gut-brain Axis for Improving Psychocognitive Health Outcomes of Critical Illness Survivors
This study is testing if eating more fermented foods can help people who have survived serious illnesses, like severe COVID-19, feel better mentally and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT06020703 on ClinicalTrials.gov |
What this trial studies
This study investigates whether a high fermented food diet can improve the quality of life for patients who have survived critical illnesses, including severe COVID-19, by promoting gut health and reducing inflammation. It focuses on individuals who have experienced cognitive and mental health impairments post-ICU stay. The research aims to leverage the gut-brain axis concept, suggesting that dietary changes may positively influence mental health outcomes. Participants will be monitored for tolerability and effectiveness of the diet in enhancing recovery.
Who should consider this trial
Good fit: Ideal candidates are patients who have survived critical illness or severe COVID-19 and are experiencing mild cognitive impairments.
Not a fit: Patients with a history of dementia, severe mental disorders, or those unable to tolerate a diet by mouth will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance the mental health and quality of life for survivors of critical illness.
How similar studies have performed: While the concept of nutritional psychiatry is emerging, this specific approach has not been widely tested, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Rochester, Minnesota
- Mayo Clinic Minnesota — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Lioudmila Karnatovskaia, MD — Mayo Clinic
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.