Actively Recruiting
Efficacy of Clostridium Butyricum in Alleviating Anxiety and Depression in Patients With Functional Dyspepsia
Led by Xijing Hospital of Digestive Diseases · Updated on 2026-01-05
180
Participants Needed
1
Research Sites
88 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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. Methods: This trial plans to enroll 180 patients (90 per group). The study will employ a double-blind design. For patients diagnosed with FD according to the Rome IV criteria, in addition to conventional treatment (treated with Mosapride Citrate Tablets (Guangdong Anno Guocai) for Postmeal Discomfort Syndrome (PDS) and Esomeprazole Enteric Coated Tablets (Shijiazhuang Longze Pharmaceutical Guocai) for Upper Abdominal Pain Syndrome (EPS)), the experimental group was treated with Clostridium butyricum, while the control group received a placebo with the same appearance and odor. The treatment intervention will last for 4 weeks. The main indicator of this experiment is the improvement of the Hospital Anxiety and Depression Scale (HADS score) after 4 weeks of treatment. The secondary indicators are the improvement rate of the overall treatment effectiveness evaluation questionnaire (OTE questionnaire), the improvement of the global overall symptom score (GOS score), the improvement of the simplified Nipin scale (SF-NDI), and the improvement of the Pittsburgh Sleep Index (PSQI) after 4 weeks of treatment. Upon completion of the trial, the patients' conditions will be re-evaluated, and treatment plans will be adjusted accordingly.
CONDITIONS
Official Title
Efficacy of Clostridium Butyricum in Alleviating Anxiety and Depression in Patients With Functional Dyspepsia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with functional dyspepsia according to Rome IV criteria
- Aged between 18 and 80 years, any gender
- Hospital Anxiety and Depression Scale (HADS) score between 8 and 14
You will not qualify if you...
- Use of probiotics or antibiotics within 1 month before the study
- Use of psychoactive drugs including hypnotics, sedatives, anxiolytics, or antidepressants within 1 month
- Use of hormones, immunosuppressants, or cytotoxic agents within 1 month
- Participation in another clinical trial within 1 month
- Positive Helicobacter pylori infection test
- Long-term use of traditional Chinese herbal medicine
- Pregnancy or breastfeeding
- History of drug abuse
- Comorbidities like irritable bowel syndrome, gastroesophageal reflux disease, functional constipation, severe liver, kidney, lung, autoimmune diseases, bleeding disorders, psychiatric or endocrine diseases
- History of major surgery or diabetes mellitus
- Refusal to provide written informed consent
AI-Screening
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Trial Site Locations
Total: 1 location
1
Air Force Medical University
Xi’an, Shanxi, China
Actively Recruiting
Research Team
Y
Yongquan Shi Shi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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