NCT07268729

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: University of Toronto · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	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.
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.

Timeline

• Start date: 2025-12-10
• Primary completion: 2025-12-20
• Completion: 2026-01-10
• First posted: 2025-12-08
• Last updated: 2025-12-08

Locations

1 site across 1 country: Canada