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

NCT ID: NCT07187492

Last Updated: 2026-01-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-20
• Study Completion Date: 2027-05-31

Brief Summary

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.

Conditions

Functional Dyspepsia; Probiotics; Depression; Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

The probiotic group

Probiotic Group:

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.

Group Type: EXPERIMENTAL

Bacillus coagulans

Intervention Type: 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.

The placebo group

Placebo Group:

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).

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: 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).

Interventions

Bacillus coagulans

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.

Intervention Type: DRUG

placebo

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).

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xijing Hospital of Digestive Diseases

OTHER

Sponsor Role: lead

Responsible Party

Yongquan Shi

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Air Force Medical University

Xi’an, Shanxi, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yongquan Shi Shi

Role: CONTACT

shiyquan@fmmu.edu.cn

029-84771515

Other Identifiers

KY20252363-C-1-1

Identifier Type: -

Identifier Source: org_study_id