Actively Recruiting
Efficacy of Clostridium Butyricum in Alleviating Anxiety and Depression in Patients With Functional Dyspepsia: A Prospective, Double-Blind, Randomized, Placebo-Controlled Clinical Trial
Led by Xijing Hospital of Digestive Diseases · Updated on 2026-01-05
180
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of Clostridium butyricum in improving anxiety and depression symptoms in patients diagnosed with functional dyspepsia according to the Rome IV criteria. This phase 4, double-blind, randomized, placebo-controlled trial aims to study how this probiotic affects mental health alongside conventional treatments for two subtypes of functional dyspepsia: postprandial distress syndrome (PDS) and epigastric pain syndrome (EPS). Participants are divided into two groups. The experimental group receives Clostridium butyricum twice daily combined with standard medications—Mosapride Citrate Tablets for PDS or Esomeprazole Enteric-Coated Tablets for EPS. The control group receives a placebo matching Clostridium butyricum in appearance and odor, alongside the same conventional treatments. Treatment lasts for four weeks. During the study, participants will be evaluated using the Hospital Anxiety and Depression Scale (HADS) to measure changes in anxiety and depression after four weeks. Additional assessments include questionnaires on overall treatment effectiveness, global symptom severity, dyspepsia-related quality of life, and sleep quality. Researchers will monitor participants' conditions throughout and adjust treatment plans after the trial. The total participation duration is approximately four weeks of treatment and assessment.
CONDITIONS
Brief 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...
- Patients diagnosed with functional dyspepsia according to the Rome IV criteria
- Aged 18 to 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 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 infection
- Long-term use of traditional Chinese herbal medicine
- Pregnancy or lactation
- History of drug abuse
- Comorbidities such as irritable bowel syndrome, gastroesophageal reflux disease, functional constipation, or other significant conditions including severe hepatic, renal, respiratory, or autoimmune disorders; bleeding diatheses; psychiatric diseases; endocrine disorders
- History of major surgery or diagnosis of diabetes mellitus
- Refusal to provide written informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants receive either Clostridium butyricum or placebo along with standard medication for their type of functional dyspepsia to alleviate anxiety and depression symptoms.
Weekly visits for up to 4 weeks
Trial Site Locations
Total: 1 location
1
Air Force Medical University
Xi’an, Shanxi, China
Actively Recruiting
Research Team
Y
Yongquan Shi Shi
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here