Clostridium butyricum for anxiety and depression in functional dyspepsia

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

This trial will test whether taking the probiotic Clostridium butyricum for four weeks can reduce anxiety and depression symptoms in adults with functional dyspepsia.

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: NCT07182890 on ClinicalTrials.gov

What this trial studies

This randomized, double-blind Phase 4 trial will enroll 180 adults with functional dyspepsia (90 per group) who have mild-to-moderate anxiety or depression (HADS 8–14). All participants will continue conventional FD treatment while one group receives oral Clostridium butyricum and the other receives a matched placebo for four weeks. The primary outcome is change in Hospital Anxiety and Depression Scale (HADS) score after four weeks, with secondary outcomes likely including symptom and safety measures. The design excludes recent probiotic/antibiotic use, recent psychoactive medication, and H. pylori–positive patients to isolate the probiotic's effect on mood symptoms.

Who should consider this trial

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

Not a fit: Patients with severe mood disorders (HADS outside 8–14), positive H. pylori, recent antibiotic or probiotic use, ongoing psychoactive medication, major comorbid GI disorders, pregnancy, or a history of substance abuse are unlikely to benefit from participation.

Why it matters

Potential benefit: If effective, the probiotic could offer a low-risk adjunct to standard FD care that reduces anxiety and depression symptoms.

How similar studies have performed: Prior probiotic studies and early research on gut–brain interactions have shown mixed but sometimes modest improvements in mood, while evidence specifically for Clostridium butyricum in this context is limited and preliminary.

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