Bacillus coagulans to ease anxiety and depression in people with functional dyspepsia

Efficacy of Bacillus Coagulans in Alleviating Anxiety and Depression in Patients With Functional Dyspepsia：A Prospective, Double-Blind, Randomized, Placebo-Controlled Clinical Trial

This trial will try giving Bacillus coagulans to adults with functional dyspepsia and mild-to-moderate anxiety or depression to see if their HADS scores improve after 4 weeks.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 180 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Xijing Hospital of Digestive Diseases (Academic / other)
• Locations: 1 site (Xi’an, Shanxi)
• Trial ID: NCT07187492 on ClinicalTrials.gov

What this trial studies

This is a randomized, double-blind, placebo-controlled Phase 4 trial enrolling 180 patients with functional dyspepsia defined by Rome IV criteria. All participants continue standard FD therapy (mosapride for PDS or esomeprazole for EPS) and are randomized 1:1 to receive either Bacillus coagulans or a matching placebo for 4 weeks. The primary outcome is change in Hospital Anxiety and Depression Scale (HADS) score after 4 weeks, with secondary outcomes monitoring safety and other symptom measures. Key eligibility includes age 18–80 and HADS scores between 8 and 14, while recent use of probiotics, antibiotics, psychoactive drugs, positive H. pylori status, pregnancy, or major comorbid functional GI disorders are exclusions.

Who should consider this trial

Good fit: Adults aged 18–80 with functional dyspepsia per Rome IV and HADS scores of 8–14 who have not used probiotics, antibiotics, or psychoactive medications in the prior month and who are not pregnant or H. pylori-positive.

Not a fit: Patients with positive H. pylori tests, current use of psychoactive drugs, recent probiotic/antibiotic use, pregnancy, severe psychiatric illness, or major overlapping GI disorders like IBS or GERD are unlikely to benefit from participation.

Why it matters

Potential benefit: If effective, this could provide a low-risk probiotic option to reduce anxiety and depressive symptoms in FD patients alongside standard gastrointestinal treatments.

How similar studies have performed: Some probiotic trials have shown modest mood improvements in gut disorders, but results are mixed and evidence specifically for Bacillus coagulans in FD-related anxiety/depression is limited.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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.

Where this trial is running

Xi’an, Shanxi

• Air Force Medical University — Xi’an, Shanxi, China (Recruiting)

Study contacts

• Study coordinator: Yongquan Shi Shi

Conditions Functional Dyspepsia; Probiotics; Depression; Anxiety