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A Study of Healthy Microbiome, Healthy Mind

Primary Purpose

Critical Illness, COVID-19, PICS

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fermented Food Diet
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Critical Illness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: - Patients who survived critical illness 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. 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).

Sites / Locations

  • Mayo Clinic Minnesota

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Fermented Foods Diet

Normal Diet

Arm Description

Subjects will incorporate fermented food into their diet.

Subjects will continue their regular diet.

Outcomes

Primary Outcome Measures

Feasibility of high fermented food diet among critical illness survivors
20 critical illness survivors assigned to the intervention arm will tolerate high fermented food diet on 75% of the study days or more
gut microbiome diversity
assessed using Shannon index

Secondary Outcome Measures

Change in inflammatory cytokines
Targeted analyses will be performed to compare the values of inflammatory markers such as tumor necrosis factor-alpha, interleukin-2, interleukin-2 soluble receptor, interleukin-4, interleukin-5, interleukin-6, interleukin-8, interleukin-10, interleukin-12 interleukin-13, interleukin-17, interferon-gamma and interferon-1beta. All marker levels are measured in pg/ml.
Symptoms of anxiety and depression
Measured using the self-reported Hospital Anxiety and Depression Scale (HADS). Total questions: 14. Anxiety 7, Depression 7. Each item is rated on a 4-point scale from 0 "absence" to 3 "extreme presence". Total score is 21 per subscale: 0 - 7: Normal levels of anxiety/depression; 8-10: Borderline abnormal; > 11: Abnormal
Cognitive Assessment
Measured using the Montreal Cognitive Assessment (MoCA-BLIND). Total questions:13. Memory 3 Attention 4 Language 3 Abstraction 2 Orientation 1. Subscores for each of the 5 sections are calculated. The total score is summed from the subscores, with a maximum score of 22. A score equal > 18 is considered normal cognition
Self-Reported quality of life
Measured using the self-reported EuroQol-5D-3L questionnaire. Total questions: 6. Mobility: 1, Self-Care: 1, Usual Activities: 1, Pain/discomfort: 1, Anxiety/depression: 1, Health State - Visual Analog Scale: 1. 3L - 3 levels of severity: no problems, some problems, extreme problems. The visual analog scale ranges from 0 to 100 with higher scores reflecting better perceived current health-related quality of life state.
symptoms of acute stress/PTSD
Measured using Impact of Events-revised (IES-r). Total questions: 22. Intrusion 7, Avoidance 8, Hyperarousal 7. Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). Total scores are summed with higher scores indicating greater distress with regards to a specific event. Orientation 1

Full Information

First Posted
August 23, 2023
Last Updated
September 8, 2023
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT06020703
Brief Title
A Study of Healthy Microbiome, Healthy Mind
Official Title
Healthy Microbiome, Healthy Mind: Using Gut-brain Axis for Improving Psychocognitive Health Outcomes of Critical Illness Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2, 2023 (Anticipated)
Primary Completion Date
April 30, 2025 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
Critical illness, including severe COVID, often lead to long term cognitive and mental health complications. Current non-pharmacological interventions, including ABCDEF bundle, are of limited efficacy. The largest psychological intervention trial to date also demonstrated no beneficial effect. These impairments may persist for years and are associated with chronic pain, impaired physical functioning, decreased quality of life, increased use of psychotropic medications, opioid abuse, self-harm, and increased acute care service utilization. Half of previously employed critical illness survivors, including those with long COVID, are not able to return to work a year later resulting in loss of insurance and difficulty in seeking professional help. Increasing recognition that the nervous system and the gastrointestinal tract are communicating through a bidirectional network of signaling pathways, collectively known as the gut-brain-axis, resulted in emergence of a novel discipline of "nutritional psychiatry" advocating that diet and nutrition may be central determinants of both physical and mental health. In the outpatient setting, fiber rich Mediterranean style diet has been linked to improvements in cognitive and mood symptoms possibly via its known anti-inflammatory effect whereby diets high in sugars and refined grains with high inflammatory potential have been linked to the development of depression. Critical illness and associated interventions lead to the loss of normal gut bacteria, allowing overgrowth of disease-promoting pathogenic bacteria resulting in severe dysbiosis. During dysbiosis, gut-brain pathways are dysregulated resulting in neuroinflammation, anxiety and depressive-like behaviors as well as cognitive impairment. Dysbiosis can persist months after the resolution of critical illness. Restoration of healthy microbiome may thus be key to facilitating psychiatric and cognitive recovery after critical illness. Can the Mediterranean diet be used to restore microbiome diversity in this population? Perhaps not right away, as critical illness survivors have significant decrease in fiber degrading bacterial organisms. Others demonstrated that high-fiber diet alone does not result in increased microbial community diversity. What about probiotics? In patients with antibiotics-associated dysbiosis, probiotics induced a persistently incomplete indigenous stool microbiome recovery. How can microbiome diversity be restored? Fermented foods may be the most promising approach. Consumption of fermented milk facilitated restoration of gut homeostasis in patients with irritable bowel syndrome and increased their "feeling good" scores. Other human intervention studies using fermented tea, sauerkraut, fermented plant extract, kimchi, and fermented soybean milk reported increased presence of bacteria in the gut known for their health promoting properties. Consumption of fermented foods was associated with positive modulation in brain activity and fewer symptoms of social anxiety. A 10-week high fermented food diet intervention demonstrated increased microbiota diversity and decreased inflammatory markers among healthy volunteers. Can it be applied to survivors of critical illness including COVID to help them recover from dysbiosis and inflammation, and improve their mental health and other outcomes? Specific Aim #1: to evaluate feasibility of high fermented food diet among critical illness survivors and its effect on microbiome diversity Hypothesis 1a: critical illness survivors will tolerate high fermented food diet Hypothesis 1b: high fermented food diet will increase microbiome diversity in critical illness survivors. Specific Aim #2: to evaluate the effect of high fermented food diet on immune system performance and recovery, mental health, cognition, and quality of life of critical illness survivors. Hypothesis 2a: high fermented food diet will improve immune system performance among critical illness survivors. Hypothesis 2b: critical illness survivors treated with fermented food diet for 3 months will have a reduction in symptoms of anxiety, depression and acute stress/PTSD Hypothesis 2c: critical illness survivors treated with fermented food diet for 3 months will have improvement in cognition. Hypothesis 2c: critical illness survivors treated with fermented food diet for 3 months will have improvement in quality of life.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness, COVID-19, PICS, Cognitive Impairment, Mental Health Impairment, Weakness, Muscle, Dysbiosis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fermented Foods Diet
Arm Type
Experimental
Arm Description
Subjects will incorporate fermented food into their diet.
Arm Title
Normal Diet
Arm Type
No Intervention
Arm Description
Subjects will continue their regular diet.
Intervention Type
Behavioral
Intervention Name(s)
Fermented Food Diet
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility of high fermented food diet among critical illness survivors
Description
20 critical illness survivors assigned to the intervention arm will tolerate high fermented food diet on 75% of the study days or more
Time Frame
12 weeks
Title
gut microbiome diversity
Description
assessed using Shannon index
Time Frame
Baseline, 12 weeks
Secondary Outcome Measure Information:
Title
Change in inflammatory cytokines
Description
Targeted analyses will be performed to compare the values of inflammatory markers such as tumor necrosis factor-alpha, interleukin-2, interleukin-2 soluble receptor, interleukin-4, interleukin-5, interleukin-6, interleukin-8, interleukin-10, interleukin-12 interleukin-13, interleukin-17, interferon-gamma and interferon-1beta. All marker levels are measured in pg/ml.
Time Frame
Baseline, 12 weeks
Title
Symptoms of anxiety and depression
Description
Measured using the self-reported Hospital Anxiety and Depression Scale (HADS). Total questions: 14. Anxiety 7, Depression 7. Each item is rated on a 4-point scale from 0 "absence" to 3 "extreme presence". Total score is 21 per subscale: 0 - 7: Normal levels of anxiety/depression; 8-10: Borderline abnormal; > 11: Abnormal
Time Frame
Baseline, 12 weeks
Title
Cognitive Assessment
Description
Measured using the Montreal Cognitive Assessment (MoCA-BLIND). Total questions:13. Memory 3 Attention 4 Language 3 Abstraction 2 Orientation 1. Subscores for each of the 5 sections are calculated. The total score is summed from the subscores, with a maximum score of 22. A score equal > 18 is considered normal cognition
Time Frame
Baseline, 12 weeks
Title
Self-Reported quality of life
Description
Measured using the self-reported EuroQol-5D-3L questionnaire. Total questions: 6. Mobility: 1, Self-Care: 1, Usual Activities: 1, Pain/discomfort: 1, Anxiety/depression: 1, Health State - Visual Analog Scale: 1. 3L - 3 levels of severity: no problems, some problems, extreme problems. The visual analog scale ranges from 0 to 100 with higher scores reflecting better perceived current health-related quality of life state.
Time Frame
Baseline, 12 weeks
Title
symptoms of acute stress/PTSD
Description
Measured using Impact of Events-revised (IES-r). Total questions: 22. Intrusion 7, Avoidance 8, Hyperarousal 7. Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). Total scores are summed with higher scores indicating greater distress with regards to a specific event. Orientation 1
Time Frame
Baseline, 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - Patients who survived critical illness 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. 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lioudmila Karnatovskaia, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Minnesota
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

A Study of Healthy Microbiome, Healthy Mind

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