Actively Recruiting
Efficacy of Bacillus Coagulans 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 Bacillus coagulans 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 Bacillus coagulans, 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 Bacillus Coagulans 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 the Rome IV criteria
- Aged between 18 and 80 years
- 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 disorders including severe hepatic, renal, respiratory, autoimmune, bleeding, psychiatric, or endocrine diseases
- History of major surgery or diagnosis of 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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