Ignite Creation Date:
2025-12-24 @ 3:14 PM
Ignite Modification Date:
2025-12-24 @ 3:14 PM
Study NCT ID:
NCT07187492
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-23
First Post:
2025-09-14
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Bacillus Coagulans in Alleviating Anxiety and Depression in Patients With Functional Dyspepsia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C562118', 'term': 'exopolysaccharide biopolymer, Bacillus coagulans'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-18', 'studyFirstSubmitDate': '2025-09-14', 'studyFirstSubmitQcDate': '2025-09-18', 'lastUpdatePostDateStruct': {'date': '2025-09-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hospital Anxiety and Depression Scale (HADS)', 'timeFrame': '4 weeks', 'description': "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."}], 'secondaryOutcomes': [{'measure': 'Overall Treatment Evaluation (OTE) questionnaire', 'timeFrame': '4 weeks', 'description': '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.'}, {'measure': 'Global Overall Symptom scale (GOS score)', 'timeFrame': '4 weeks', 'description': '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.'}, {'measure': 'Short-form Nepean Dyspepsia Index (SF-NDI)', 'timeFrame': '4 weeks', 'description': '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.'}, {'measure': 'Pittsburgh Sleep Quality Index (PSQI)', 'timeFrame': '4 weeks', 'description': '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.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Functional Dyspepsia', 'Probiotics', 'Depression', 'Anxiety']}, 'descriptionModule': {'briefSummary': "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.\n\nMethods: 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.\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with functional dyspepsia (FD) according to the Rome IV criteria.\n* Aged 18 to 80 years, regardless of gender.\n* Hospital Anxiety and Depression Scale (HADS) score between 8 and 14.\n\nExclusion Criteria:\n\n* Use of probiotics or antibiotics within one month prior to the trial.\n* Use of psychoactive medications (including hypnotics, sedatives, anxiolytics, or antidepressants) within one month prior to the trial.\n* Use of hormones, immunosuppressants, or cytotoxic agents within one month prior to the trial.\n* Participation in any other clinical trial within one month prior to the study.\n* Positive test for Helicobacter pylori (Hp) infection.\n* Long-term use of traditional Chinese herbal medicine.\n* Pregnancy or lactation.\n* History of drug abuse.\n* 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.\n* History of major surgery or diagnosis of diabetes mellitus.\n* Refusal to provide written informed consent.'}, 'identificationModule': {'nctId': 'NCT07187492', 'briefTitle': 'Efficacy of Bacillus Coagulans in Alleviating Anxiety and Depression in Patients With Functional Dyspepsia', 'organization': {'class': 'OTHER', 'fullName': 'Xijing Hospital of Digestive Diseases'}, 'officialTitle': 'Efficacy of Bacillus Coagulans in Alleviating Anxiety and Depression in Patients With Functional Dyspepsia：A Prospective, Double-Blind, Randomized, Placebo-Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'KY20252363-C-1-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'The probiotic group', 'description': 'Probiotic Group:\n\nPatients with postprandial distress syndrome (PDS) will receive Mosapride Citrate Tablets 5 mg three times daily, along with Bacillus coagulans 1050 mg three times daily.\n\nPatients with epigastric pain syndrome (EPS) will receive Esomeprazole Enteric-Coated Tablets 20 mg once daily, along with Bacillus coagulans 1050 mg three times daily.', 'interventionNames': ['Drug: Bacillus coagulans']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'The placebo group', 'description': 'Placebo Group:\n\nPatients 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).\n\nPatients 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).', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'Bacillus coagulans', 'type': 'DRUG', 'description': '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.\n\nPatients with epigastric pain syndrome (EPS) will receive Esomeprazole Enteric-Coated Tablets 20 mg once daily, along with Bacillus coagulans 1050 mg three times daily.', 'armGroupLabels': ['The probiotic group']}, {'name': 'placebo', 'type': 'DRUG', 'description': '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).\n\nPatients 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).', 'armGroupLabels': ['The placebo group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Yongquan Shi Shi', 'role': 'CONTACT', 'email': 'shiyquan@fmmu.edu.cn', 'phone': '029-84771515'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xijing Hospital of Digestive Diseases', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Yongquan Shi', 'investigatorAffiliation': 'Xijing Hospital of Digestive Diseases'}}}}