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NCT Number: NCT07187492

Efficacy of Bacillus Coagulans in Alleviating Anxiety and Depression in Patients With Functional Dyspepsia

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.

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Key information

Conditions

Functional Dyspepsia Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders Probiotics

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Air Force Medical University

Xi’an, Shanxi, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bacillus coagulans

Drug

Patients with postprandial distress syndrome (PDS) will receive Mosapride Citrate Tablets 5 mg three times daily, along with Bacillus coagulans 1050 mg three times daily.

Patients with epigastric pain syndrome (EPS) will receive Esomeprazole Enteric-Coated Tablets 20 mg once daily, along with Bacillus coagulans 1050 mg three times daily.

Placebo

Drug

Patients with PDS will receive Mosapride Citrate Tablets 5 mg three times daily, plus a placebo identical in appearance and odor to Bacillus coagulans (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 Bacillus coagulans (with identical dosage and frequency).

Primary outcomes

  1. Hospital Anxiety and Depression Scale (HADS)

    Time frame: 4 weeks

    Hospital Anxiety and Depression Scale (HADS) is divided into an anxiety subscale (7 questions) and a depression subscale (7 questions), with each subscale scoring 0-21 points. The higher the score, the more severe the patient's anxiety and depression.

Secondary outcomes

  1. Overall Treatment Evaluation (OTE) questionnaire

    Time frame: 4 weeks

    The OTE questionnaire uses the question "How have your stomach symptoms been in the past week compared to the baseline period?" scored on a 7-point Likert scale, with options of "extremely improved," "improved," "slightly improved," "unchanged," "slightly aggravated," "aggravated," or "extremely aggravated." If the patient answers "extremely improved" or "improved," it is considered a response, otherwise it is considered an unresponsive.

  2. Global Overall Symptom scale (GOS score)

    Time frame: 4 weeks

    The GOS score evaluates 10 types of gastrointestinal symptoms, with each symptom scoring 1-7 points and a total score of 10-70 points. The higher the score, the more severe the symptoms.

  3. Short-form Nepean Dyspepsia Index (SF-NDI)

    Time frame: 4 weeks

    Use Short-form Nepean Dyspepsia Index (SF-NDI) to evaluate the quality of life of patients, which includes 10 questions. Each question scores 1-5 points. The higher the score, the worse the quality of life.

  4. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: 4 weeks

    Pittsburgh Sleep Quality Index (PSQI) is a self-assessment scale used to evaluate sleep quality within the past month. It contains 7 components, each scored on a scale of 0-3, with a final total score range of 0-21. The higher the score, the worse the sleep quality.

Study contacts

Contact information is provided by the study sponsor or research team.

Yongquan Shi Shi

CONTACT

[email protected]

029-84771515

Sponsors and collaborators

Lead sponsor

Xijing Hospital of Digestive Diseases

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Sep 23, 2025
Registry last updated
Jan 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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