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A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Anxiety

A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Anxiety

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04211376
Enrollment
0
Registered
2019-12-26
Start date
2020-03-02
Completion date
2030-07-31
Last updated
2025-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Anxiety Depression, Anxiety Disorders

Brief summary

This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.

Detailed description

The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to infection with anxiety

Interventions

OTHERNo Intervention

There is no intervention for this study

Sponsors

ProgenaBiome
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study a. May be signed by parent or legal guardian in the case of minor or adult unable to provide consent 2. Male or female of all ages 3. Diagnosis of anxiety based on DSM-V criteria

Exclusion criteria

1. Refusal to sign informed consent form 2. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy. 3. Postoperative stoma, ostomy, or ileoanal pouch 4. Participation in any experimental drug protocol within the past 12 weeks 5. Treatment with total parenteral nutrition

Design outcomes

Primary

MeasureTime frameDescription
Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome SequencingThree yearsRelative abundance of bacterial classes within taxonomic phyla and, more broadly, within their domain will be analyzed by sequencing the gut microbiome. These data will then be categorized with anxiety

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026