MACO: Microbiome, Anxiety and Cognitive Orientation Study

Sponsor

Endominance (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05388630

Collaborator

Dr. John J. Ratey (Other), HEM Pharma Inc. (Industry)

2,000

Enrollment

Location

Anticipated Duration (Months)

166.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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). Our 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.

Condition or Disease	Intervention/Treatment	Phase
Anxiety Microbiome Mood Disorders Neurodegeneration Depression

Detailed 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 our research 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. To our knowledge, no other studies have been performed to date combining these research areas or their impacts on humans.

Study Design

Study Type:

Observational

Anticipated Enrollment :

2000 participants

Observational Model:

Ecologic or Community

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

May 1, 2022

Anticipated Primary Completion Date :

Apr 11, 2023

Anticipated Study Completion Date :

May 1, 2023

Outcome Measures

Primary Outcome Measures

4EPS [12 months]
Stool samples will be lab processed and analyzed for 4-EPS levels
COSEC scores [12 months]
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.
Anxiety Scores [12 months]
GAD-7: Generalized Anxiety Disorder 7 is a self-reported questionnaire for screening and severity measuring of generalized anxiety disorder.
Depression Scores [12 months]
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.
Lifestyle and Health Survey [12 months]
Demographic, health, and lifestyle data.