Investigation of Pathogenic Gut Microbiota Patterns in Anxiety, Depression and Panic Disorders

NCT ID: NCT07268729

Last Updated: 2025-12-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-12-10
• Study Completion Date: 2026-01-10

Brief Summary

This study aims to investigate the etiology of anxiety, depression, and panic disorders, providing new evidence and insights into the root causes and effective treatments, potentially offering a novel approach to achieving complete recovery.

Detailed Description

Background: Anxiety, depression and panic disorders are among the most prevalent mental health conditions globally, affecting millions and imposing a substantial burden on individuals, families, and healthcare systems. These disorders often manifest through recurrent, severe episodes of anxiety and fear, frequently accompanied by physical symptoms such as palpitations, chest pain, and dizziness, which can lead to significant functional impairment and diminished quality of life. While current treatment options include pharmacotherapy and cognitive-behavioral therapy, response rates vary, and many patients experience residual symptoms or adverse effects, leading to high rates of treatment discontinuation. Furthermore, the growing recognition of treatment-resistant anxiety, depression and panic disorders highlights an urgent need for innovative, evidence-based therapies that provide sustained relief without compromising safety.

Introduction Anxiety, depression and panic disorders are pervasive and debilitating chronic mental health conditions, affecting approximately 20% of the global population over a lifetime. Characterized by episodes of intense fear and physical symptoms such as heart palpitations, shortness of breath, and dizziness, these disorders can severely impact daily functioning, interpersonal relationships, and overall quality of life. Individuals with these conditions are also at increased risk for comorbidities including depression, substance use disorders, and cardiovascular disease, further complicating their clinical profile and necessitating more comprehensive treatment strategies.

Despite the availability of pharmacotherapy, such as selective serotonin reuptake inhibitors (SSRIs) and benzodiazepines, alongside cognitive-behavioral therapy (CBT), there remain substantial challenges in achieving and maintaining symptom relief. Response rates vary widely, and a significant proportion of patients experience partial or inadequate relief, with some exhibiting treatment-resistant symptoms. Moreover, pharmacological treatments can be associated with side effects like weight gain, fatigue, and cognitive impairment, which may lead to discontinuation or non-adherence. These limitations highlight a critical need for alternative or adjunctive interventions that can provide more effective, sustainable, and safer outcomes.

This trial was therefore designed to assess the prevalence of pathogenic gut bacteria among patients with anxiety, depression, and panic disorder compared to healthy controls.

Objective: This study aims to investigate the etiology of anxiety, depression, and panic disorders, providing new evidence and insights into the root causes, potentially offering a novel approach to these conditions..

Findings from this study are anticipated to advance clinical understanding and treatment options for anxiety, depression and panic disorders, providing a potentially more effective approach and that provide lasting relief for patients struggling with these conditions.

Conditions

Anxiety; Panic Disorder; Mood Disorders; Depression

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients under ongoing treatment

Participants in this group are adults currently receiving ongoing treatment for anxiety, depression, or panic disorder. Treatment may include prescribed medication, psychotherapy, or other clinician-supervised care. These participants will complete the same baseline psychological assessments and stool microbiome testing as the other cohorts. Their data will help evaluate how existing treatments may influence gut microbiome composition and mental-health outcomes over time.

H pylori stool test

Intervention Type: DIAGNOSTIC_TEST

Participants will provide a stool sample for noninvasive testing to detect the presence of Helicobacter pylori bacteria. The test will be performed using a validated laboratory assay that identifies H. pylori antigens in stool. Results will be used to assess potential associations between H. pylori infection, gut microbiome composition, and symptoms of anxiety or depression. The test is diagnostic only and does not involve administration of any drug or treatment.

Bacterial stool analysis

Intervention Type: DIAGNOSTIC_TEST

Participants will provide stool samples for microbiome sequencing using a validated laboratory assay. The analysis will characterize bacterial taxa within the gut microbiome and identify potential pathogenic species. Sequencing results will be correlated with psychological assessments and clinical measures to investigate relationships between gut microbial composition and symptoms of anxiety, depression, and panic disorder.

Healthy controls with no psychiatric history

Participants in this group are healthy adults with no self-reported or clinically diagnosed history of psychiatric or neurological disorders. They will complete the same baseline assessments and biological sample collection (including stool microbiome testing) as the clinical cohort, but will not receive any treatment or individualized intervention. Their data will serve as a comparison reference to help identify microbiome and biomarker patterns associated with anxiety and depression.

H pylori stool test

Intervention Type: DIAGNOSTIC_TEST

Participants will provide a stool sample for noninvasive testing to detect the presence of Helicobacter pylori bacteria. The test will be performed using a validated laboratory assay that identifies H. pylori antigens in stool. Results will be used to assess potential associations between H. pylori infection, gut microbiome composition, and symptoms of anxiety or depression. The test is diagnostic only and does not involve administration of any drug or treatment.

Bacterial stool analysis

Intervention Type: DIAGNOSTIC_TEST

Participants will provide stool samples for microbiome sequencing using a validated laboratory assay. The analysis will characterize bacterial taxa within the gut microbiome and identify potential pathogenic species. Sequencing results will be correlated with psychological assessments and clinical measures to investigate relationships between gut microbial composition and symptoms of anxiety, depression, and panic disorder.

Patients with clinically confirmed anxiety, depression, and panic disorder.

Participants in this cohort are adults with a current, clinically confirmed diagnosis of anxiety disorder, depressive disorder, or panic disorder. Each participant will provide baseline psychological assessments and biological samples, including stool microbiome testing. Based on their results, they may receive individualized lifestyle or dietary recommendations under physician supervision. Participants will be followed over time to evaluate changes in mood, stress, and biological markers related to mental-health outcomes.

H pylori stool test

Intervention Type: DIAGNOSTIC_TEST

Participants will provide a stool sample for noninvasive testing to detect the presence of Helicobacter pylori bacteria. The test will be performed using a validated laboratory assay that identifies H. pylori antigens in stool. Results will be used to assess potential associations between H. pylori infection, gut microbiome composition, and symptoms of anxiety or depression. The test is diagnostic only and does not involve administration of any drug or treatment.

Bacterial stool analysis

Intervention Type: DIAGNOSTIC_TEST

Participants will provide stool samples for microbiome sequencing using a validated laboratory assay. The analysis will characterize bacterial taxa within the gut microbiome and identify potential pathogenic species. Sequencing results will be correlated with psychological assessments and clinical measures to investigate relationships between gut microbial composition and symptoms of anxiety, depression, and panic disorder.

Interventions

H pylori stool test

Participants will provide a stool sample for noninvasive testing to detect the presence of Helicobacter pylori bacteria. The test will be performed using a validated laboratory assay that identifies H. pylori antigens in stool. Results will be used to assess potential associations between H. pylori infection, gut microbiome composition, and symptoms of anxiety or depression. The test is diagnostic only and does not involve administration of any drug or treatment.

Intervention Type: DIAGNOSTIC_TEST

Bacterial stool analysis

Participants will provide stool samples for microbiome sequencing using a validated laboratory assay. The analysis will characterize bacterial taxa within the gut microbiome and identify potential pathogenic species. Sequencing results will be correlated with psychological assessments and clinical measures to investigate relationships between gut microbial composition and symptoms of anxiety, depression, and panic disorder.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• • Adults aged 18-65 years.

• Either of the following:

1. Diagnosed with anxiety, depression, or panic disorder according to DSM-5 criteria, regardless of current treatment status.

2. Healthy individuals with no history of psychiatric disorders (control group).

• Able to provide informed consent and stool sample.

Exclusion Criteria

• • Diagnosis of psychotic disorders or neurocognitive conditions.

• Use of systemic antibiotics or antifungals within the past 60 days.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

MedBliss Research Network

UNKNOWN

Sponsor Role: collaborator

University of Toronto

OTHER

Sponsor Role: lead

Responsible Party

Hassan Kattan

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

MedBliss Research Network

Mississauga, Ontario, Canada

Countries

Canada

Central Contacts

Hassan Kattan, BSc.

Role: CONTACT

info@medblissforcure.org

647-649-1475

Other Identifiers

Pro00084759

Identifier Type: -

Identifier Source: org_study_id