Clostridium butyricum for anxiety and depression in functional dyspepsia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: Yongquan Shi Shi
• Email: shiyquan@fmmu.edu.cn
• Phone: 029-84771515

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.