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

NCT07187492 | Recruiting Phase 4

• 1 other identifier: KY20252363-C-1-1
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Hospital Anxiety and Depression Scale (HADS)

  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.

  4 weeks

Secondary Outcomes (4)

• Overall Treatment Evaluation (OTE) questionnaire

  4 weeks

• Global Overall Symptom scale (GOS score)

  4 weeks

• Short-form Nepean Dyspepsia Index (SF-NDI)

  4 weeks

• Pittsburgh Sleep Quality Index (PSQI)

  4 weeks

Study Arms (2)

The probiotic group

EXPERIMENTAL

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.

Drug: Bacillus coagulans

The placebo group

PLACEBO COMPARATOR

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).

Drug: placebo

Interventions

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.

The probiotic group

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).

The placebo group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xijing Hospital of Digestive Diseases: lead

Study Sites (1)

Air Force Medical University

Xi’an, Shanxi, China

RECRUITING

MeSH Terms

Conditions

Depression; Anxiety Disorders

Interventions

exopolysaccharide biopolymer, Bacillus coagulans

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Central Study Contacts

Yongquan Shi Shi

CONTACT

029-84771515; shiyquan@fmmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 14, 2025
• First Posted: September 23, 2025
• Study Start: September 20, 2025
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): May 31, 2027
• Last Updated: January 5, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)