Status:
RECRUITING
Efficacy of Bacillus Coagulans 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 Bacillus coagulans in improving anxiety and depression in patients diagnosed with functional dyspepsia according to the Rome IV criteria. M...
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
NCT07187492
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