Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06020703 |
| Other study ID # |
23-005057 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 26, 2024 |
| Est. completion date |
April 2025 |
Study information
| Verified date |
February 2024 |
| Source |
Mayo Clinic |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
