Actively Recruiting
Efficacy of Bacillus Coagulans 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 effects of Bacillus coagulans on anxiety and depression symptoms in patients diagnosed with functional dyspepsia according to the Rome IV criteria. This clinical trial is designed as a prospective, double-blind, randomized, placebo-controlled study aiming to measure how this probiotic may improve mental health in these patients. The trial is sponsored by Xijing Hospital of Digestive Diseases and plans to enroll 180 participants. Participants will be randomly assigned to one of two groups. Those in the probiotic group with postprandial distress syndrome (PDS) will receive Mosapride Citrate Tablets 5 mg three times daily plus Bacillus coagulans 1050 mg three times daily. Those with epigastric pain syndrome (EPS) will receive Esomeprazole Enteric-Coated Tablets 20 mg once daily plus Bacillus coagulans 1050 mg three times daily. The placebo group will receive the same conventional treatments for PDS or EPS but with a placebo matching Bacillus coagulans in appearance and dose. The treatment duration for all participants is 4 weeks. During the trial, participants' anxiety and depression levels will be assessed using the Hospital Anxiety and Depression Scale (HADS) after the 4-week treatment. Secondary measures include the Overall Treatment Evaluation questionnaire, Global Overall Symptom scale, Short-form Nepean Dyspepsia Index, and Pittsburgh Sleep Quality Index, all evaluated after 4 weeks. After completing the trial, patients will be re-evaluated and their treatment plans adjusted accordingly to monitor treatment effects and safety.
CONDITIONS
Brief Title
Efficacy of Bacillus Coagulans 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 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 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 assigned medications including Bacillus coagulans or placebo along with standard therapy based on their syndrome type.
Weekly visits for 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
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