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Fecal Microbiota Transplantation from Anxiety Disorder Patients: Effects on Anxiety-like Behavior and Mechanistic Insights in Germ-free Mice

Fecal Microbiota Transplantation from Anxiety Disorder Patients: Effects on Anxiety-like Behavior and Mechanistic Insights in Germ-free Mice

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500097560
Enrollment
Unknown
Registered
2025-02-20
Start date
2025-09-29
Completion date
Unknown
Last updated
2025-12-15

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

Conditions

Anxiety Disorder

Interventions

Healthy Control Group:None

Sponsors

Xijing Hospital, the Fourth Military Medical University, Xi'an, China
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: I. Anxiety Disorder Group 1. Approval from the Ethics Committee was obtained, and all participants (or their guardians) provided written informed consent; 2. 200 patients with anxiety disorders meeting the DSM-5 diagnostic criteria; Hamilton Anxiety Scale (HAMA) score >=14; age 18-65 years; 3. No use of prebiotics, probiotics, or probiotic-fermented foods within the past month; 4. No use of any antibiotics within the past month. II. Healthy Control Group 1. Approval from the Ethics Committee was obtained, and all participants (or their guardians) provided written informed consent; 2. 100 adults, aged 18-65 years; 3. No use of prebiotics, probiotics, or probiotic-fermented foods within the past month; 4. No use of any antibiotics within the past month.

Exclusion criteria

Exclusion criteria: 1. Presence of the following diseases: Gastrointestinal diseases: Inflammatory bowel disease, Crohn's disease, pancreatitis, fatty liver, etc. Coronary heart disease. Systemic autoimmune diseases (e.g., systemic lupus erythematosus, Behçet's disease, multiple sclerosis, connective tissue diseases). Atopic diseases (e.g., moderate to severe asthma, eczema, gastrointestinal eosinophilic disorders). Chronic pain syndromes (e.g., chronic fatigue syndrome, fibromyalgia). Neurological/neurodevelopmental disorders. 2. Obesity or metabolic abnormalities: Obesity: BMI >= 28.0. Hyperglycemia: Fasting plasma glucose (FPG) >= 6.1 mmol/L and/or 2-hour postprandial glucose (2hTC) >= 7.8 mmol/L and/or individuals who have been treated for diabetes. Hypertriglyceridemia: Triglycerides (TG) >= 2.3 mmol/L. Hypertension: Systolic blood pressure >= 140 mmHg or diastolic blood pressure >= 90 mmHg. 3. Pregnant or breastfeeding women. 4. Individuals with special dietary or lifestyle preferences. 5. Presence of other psychiatric disorders that meet the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). 6. Use of any psychotropic medications or antipyretic analgesics within the past 2 weeks.

Design outcomes

Primary

MeasureTime frame
Diversity of gut microbiota;Hamilton Anxiety Scale (HAMA);Panic Disorder Severity Scale (PDSS);Liebowitz Social Anxiety Scale (LSAS);Generalized Anxiety Disorder scale (GAD-7);blood metabolomics;

Countries

China

Contacts

Public ContactPeng Zhengwu

Xijing Hospital, the Fourth Military Medical University, Xi'an, China

pengzhengwu1446@163.com+86 137 2049 8280

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026