Recruiting

Observational Study

Sponsor:

Endominance

Code:

NCT05388630

Conditions

Anxiety

Microbiome

Mood Disorders

Neurodegeneration

Depression

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Study Details

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). 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.

Conditions

Anxiety

Microbiome

Mood Disorders

Neurodegeneration

Depression

Study ID

NCT05388630

Start date

Jun 1, 2022

Status verified date

Dec, 2022

Completion date

May 30, 2023

Anticipated

Primary completion date

Apr 11, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

2000 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • 4EPS [ Time Frame: up to 2 weeks ]
  • Cognitive Orientation Social-Emotional Competency (COSEC) Assessment [ Time Frame: up to 1 week ]
  • Anxiety Assessment [ Time Frame: up to 1 week ]
  • Depression Assessment [ Time Frame: up to 1 week ]
  • Lifestyle and Health Survey [ Time Frame: up to 1 week ]

Central Contacts and Locations

Central contacts

Locations

Endominance Inc.

Recruiting

Irvine, California, United States, 92618

Contacts

Principal Investigator:

John J Ratey, Dr.

More Information

Sponsor

Endominance

Last update posted

Dec 14, 2022

Last verified

Dec, 2022

Keywords

  • Lifestyle
  • Gut bacteria
  • 4-ethylphenyl sulfate 4EPS
  • Cognitive Orientation
  • Gut Brain Axis
  • Microbiome
  • Anxiety
  • Depression

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Endominance on 2022-12-14.