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Recruiting NCT07182890

Efficacy of Clostridium Butyricum in Alleviating Anxiety and Depression in Patients With Functional Dyspepsia

Phase IV Interventional Functional Dyspepsia Probiotics Depression Anxiety

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Clostridium butyricum, placebo.
Who it may be relevant to
Registry conditions: Functional Dyspepsia, Probiotics, Depression, Anxiety. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

Objective: This study aims to evaluate the effectiveness of Clostridium butyricum 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 Clostridium butyricum, 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.

Interventions

  • Drug Clostridium butyricum
    Patients with postprandial distress syndrome (PDS) will receive Mosapride Citrate Tablets 5 mg three times daily, along with Clostridium butyricum 1260 mg twice daily. Patients with epigastric pain syndrome (EPS) will receive Esomeprazole Enteric-Coated Tablets 20 mg once daily, along with Clostridium butyricum 1260 mg twice daily.
  • Drug placebo
    Patients with PDS will receive Mosapride Citrate Tablets 5 mg three times daily, plus a placebo identical in appearance and odor to Clostridium butyricum (with identical dosage and frequency). Patients with EPS will receive Esomeprazole Enteric-Coated Tablets 20 mg once daily, plus a placebo identical in appearance and odor to Clostridium butyricum (with identical dosage and frequency).

Primary outcome measures

  • Hospital Anxiety and Depression Scale (HADS) [Time frame: 4 weeks]
Secondary outcome measures (4)
  • Overall Treatment Evaluation (OTE) questionnaire [Time frame: 4 weeks]
  • Global Overall Symptom scale (GOS score) [Time frame: 4 weeks]
  • Short-form Nepean Dyspepsia Index (SF-NDI) [Time frame: 4 weeks]
  • Pittsburgh Sleep Quality Index (PSQI) [Time frame: 4 weeks]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Air Force Medical University — Xi’an

Identifiers

NCT: NCT07182890 · KY20252363-C-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗