Microbiome, Anxiety and Cognitive Orientation Study

Depression Clinical Trial

— MACO  

Official title:

The Impact of a Gut-derived Metabolite on Anxiety Behavior of Human Subjects Based on Their Cognitive Orientation Variation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05388630
• Other study ID #: 04012022
• Status: Recruiting
• Start date: June 1, 2022
• Est. completion date: May 30, 2023

Study information

• Verified date: December 2022
• Source: Endominance
• Contact: Endominance Inc.
• Phone: 1-855-788-3955
• Email: microbiome.study[@]endominance.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Mounting evidence shows that the gut microbiome plays an important role in communication within the gut-brain axis. However, the relationship between gut microbiota and their influence on anxiety is still not fully understood. Recent studies on mice found a specific microbe-produced molecule, 4-ethylphenyl sulfate (4EPS), can induce anxious behavior. 4EPS is produced by gut microbes in mice and humans. Research suggests higher 4EPS levels may strongly be associated with anxiety levels. However, anxiety is far more complicated than changes in a single molecule. There are many more factors to consider when it comes to anxiety, including various aspects of one's lifestyle and how humans perceive their environment (cognitive orientation). The primary research goal is to better understand the effects 4EPS has on human anxiety behavior and the role cognitive orientation has in connection to anxiety.

Description:

This study aims to expand and improve upon previous research on gut bacteria and their connections to anxiety. The Investigators will examine the gut microbiota and its vital role in the gut-brain axis, the link between a gut-derived bacteria (4EPS) and anxiety, and the connections between cognitive orientation and anxiety. It is hypothesized that even though higher 4EPS levels may be associated with anxiety levels in humans, such levels may be more prominent (severe) or less pronounced (less severe) in humans with variations in lifestyle and cognitive orientation.

Cross-sectional data will be compiled from a cognitive assessment (COSEC), a health/lifestyle survey, a generalized anxiety questionnaire, a depression questionnaire, and a stool sample. Stool samples will be analyzed for 4EPS levels. Using the COSEC assessment, we will divide the subjects into nine groups of unique cognitive styles based on their perception and conception scores. Then, depending on their 4EPS level and their survey responses, the relationship between the level of 4EPS and their cognitive traits will be analyzed. COSEC is a cognitive propensity and behavioral preference diagnostic tool designed to understand people's various tendencies that occur during the process of perceiving the environment and responding in action.

The long-term goal of this project is to find connections in the gut-brain axis and gain a deeper understanding of microbiome metabolites as neurodegenerative agents, as they affect anxiety levels in humans. No other studies have been performed to date combining these research areas or their impacts on humans.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: May 30, 2023
• Est. primary completion date: April 11, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participants must be 18 years of age and older

• Participants must be able to read and write English

• Participants must be able to provide consent independently

• Participants must provide a legitimate postal address/P.O Box

• Participants must have access to a device such as a computer or a smartphone

Exclusion Criteria

-Unable to provide a stool sample due to health status or functional impairment

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Depression
• Microbiome
• Mood Disorders
• Nerve Degeneration
• Neurodegeneration

Locations

Country	Name	City	State
United States	Endominance Inc.	Irvine	California

Sponsors (3)

Lead Sponsor	Collaborator
Endominance	Dr. John J. Ratey, HEM Pharma Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	4EPS	Stool samples will be lab processed and analyzed for 4-EPS levels	up to 2 weeks
Primary	Cognitive Orientation Social-Emotional Competency (COSEC) Assessment	An online cognitive propensity and behavioral preference diagnostic tool. COSEC is designed to understand people's various tendencies that occur during the process between perceiving the environment and responding in action. It illustrates an individual's personality and aptitude as an outcome shaped by their environment and the perception of the world around them.; COSEC incorporates the environmental impact on the individual by looking at the unique process of a person's perception, conception, and behavior process. Assessments are scored using an algorithm to generate quantified measurements based on multifactorial relationships between a subject's responses. Results are presented in a descriptive format, called the COBI Report (Cognitive Orientation Behavior Inventory).	up to 1 week
Primary	Anxiety Assessment	GAD-7: Generalized Anxiety Disorder 7 is a self-reported questionnaire for screening and severity measuring of generalized anxiety disorder. Scores of 5, 10, and 15 represent cut points for mild, moderate, and severe anxiety, respectively.	up to 1 week
Primary	Depression Assessment	PHQ-9: Patient Health Questionnaire is a self-administered, 9 question diagnostic tool that rates depression using 9 DSM-V criteria for depression based on the mood.A PHQ-9 score total of 0-4 points equals "normal" or minimal depression. Scoring between 5-9 points indicates mild depression, 10-14 points indicates moderate depression, 15-19 points indicates moderately severe depression, and 20 or more points indicates severe depression.	up to 1 week
Primary	Lifestyle and Health Survey	Demographic, health, and lifestyle data.	up to 1 week

External Links

•   Research Study Landing Page