Status:
RECRUITING
Efficacy of Clostridium Butyricum in Alleviating Anxiety and Depression in Patients With Functional Dyspepsia
Lead Sponsor:
Xijing Hospital of Digestive Diseases
Conditions:
Functional Dyspepsia
Probiotics
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
Objective: This study aims to evaluate the effectiveness of Clostridium butyricum in improving anxiety and depression in patients diagnosed with functional dyspepsia according to the Rome IV criteria....
Eligibility Criteria
Inclusion
- Patients diagnosed with functional dyspepsia (FD) according to the Rome IV criteria.
- Aged 18 to 80 years, regardless of gender.
- Hospital Anxiety and Depression Scale (HADS) score between 8 and 14.
Exclusion
- Use of probiotics or antibiotics within one month prior to the trial.
- Use of psychoactive medications (including hypnotics, sedatives, anxiolytics, or antidepressants) within one month prior to the trial.
- Use of hormones, immunosuppressants, or cytotoxic agents within one month prior to the trial.
- Participation in any other clinical trial within one month prior to the study.
- Positive test for Helicobacter pylori (Hp) infection.
- Long-term use of traditional Chinese herbal medicine.
- Pregnancy or lactation.
- History of drug abuse.
- Comorbidities such as irritable bowel syndrome (IBS), gastroesophageal reflux disease (GERD), functional constipation (FC), or other significant conditions that may interfere with the trial-including severe hepatic, renal, respiratory, or autoimmune disorders; bleeding diatheses; psychiatric diseases; endocrine disorders; etc.
- History of major surgery or diagnosis of diabetes mellitus.
- Refusal to provide written informed consent.
Key Trial Info
Start Date :
September 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2027
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT07182890
Start Date
September 20 2025
End Date
May 31 2027
Last Update
January 5 2026
Active Locations (1)
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1
Air Force Medical University
Xi’an, Shanxi, China