Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2025-12-28 @ 10:57 PM
Study NCT ID:
NCT06285734
Status:
RECRUITING
Last Update Posted:
2024-12-12
First Post:
2024-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Characteristics of Small Intestinal Bacterial Overgrowth in Individuals with Abdominal Distention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001944', 'term': 'Breath Tests'}], 'ancestors': [{'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'The exhaled air of the patient after taking the substrate.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 402}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-07', 'studyFirstSubmitDate': '2024-02-05', 'studyFirstSubmitQcDate': '2024-02-28', 'lastUpdatePostDateStruct': {'date': '2024-12-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Positive rate of SIBO in patients with abdominal distension', 'timeFrame': '2024-03-01 to 2025-08-01', 'description': 'Detect the positive rate of SIBO in patients with abdominal distension by breath test'}], 'secondaryOutcomes': [{'measure': 'Positive rate of abnormal OCTT in patients with abdominal distension', 'timeFrame': '2024-03-01 to 2025-08-01', 'description': 'Detect the positive rate of abnormal OCTT in patients with abdominal distension by breath test'}, {'measure': 'Correlation between clinical features of patients with abdominal distension and SIBO', 'timeFrame': '2024-03-01 to 2025-08-01', 'description': 'Analyze the correlation between clinical features of patients with abdominal distension and SIBO'}, {'measure': 'Correlation between clinical features of patients with abdominal distension and OCTT', 'timeFrame': '2024-03-01 to 2025-08-01', 'description': 'Analyze the correlation between clinical features of patients with abdominal distension and OCTT'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['abdominal distention', 'small intestinal bacterial overgrowth', 'orocecal transit time', 'cross-sectional survey'], 'conditions': ['Abdominal Distention']}, 'descriptionModule': {'briefSummary': 'Abdominal distention represents a prevalent clinical manifestation characterized by an unclear etiology and pathogenesis. This symptomatology is frequently observed in various conditions, including small intestinal bacterial overgrowth (SIBO) and abnormal orocecal transit time (OCTT). The utilization of the breath test as a non-invasive diagnostic approach has become widespread in recent years for identifying SIBO and abnormalities in OCTT. In this study, the prevalence of SIBO and OCTT irregularities in individuals presenting with abdominal distention was ascertained through the implementation of the breath test. Furthermore, the correlation between abdominal distention and SIBO/OCTT was analysed to enhance the elucidation of the underlying etiology of abdominal distention. These findings aim to offer valuable insights for refining clinical comprehension and strategies related to the diagnosis and treatment of abdominal distention.', 'detailedDescription': 'Abdominal distention represents a prevalent clinical manifestation characterized by an unclear etiology and pathogenesis. And the prevalence of abdominal distension is high in the population. This symptomatology is frequently observed in various conditions, including small intestinal bacterial overgrowth (SIBO) and abnormal orocecal transit time (OCTT). The utilization of the breath test as a non-invasive diagnostic approach has become widespread in recent years for identifying SIBO and abnormalities in OCTT. In this study, the prevalence of SIBO and OCTT irregularities in individuals presenting with abdominal distention was ascertained through the implementation of the breath test. Furthermore, the correlation between the clinical features such as severity, location, and frequency of abdominal distension and SIBO/OCTT was analysed to enhance the elucidation of the underlying etiology of abdominal distention. These findings aim to offer valuable insights for refining clinical comprehension and strategies related to the diagnosis and treatment of abdominal distention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Abdominal distension patients in the outpatient department at Qilu Hospital of Shandong University.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patients aged 18 to 70 years.\n2. Patients presenting with the primary complaint of abdominal bloating and/or abdominal distension, or those exhibiting abdominal distension with prominence over other symptoms.\n\nExclusion Criteria:\n\n1. Patients who are pregnant or lactating.\n2. Patients have history of gastrointestinal malignancy or gastrointestinal surgery.\n3. Patients manifesting food intolerance or presenting with a confirmed diagnosis or suspicion of lactose intolerance.\n4. Patients with urinary system (chronic kidney disease, etc.), immune system (scleroderma, etc.), nervous system (Parkinson's disease, etc.), mental system (depression, etc.), or other diseases outside the digestive system.\n5. Patients who used antibiotics or microecological agents or underwent endoscopic examination within two weeks.\n6. Patients with a medication history encompassing motility enhancers, secretory enhancers, antifoaming agents, spasmolytics, opioids, and antidepressants within the past week.\n7. Patients who are unwilling or incapable to provide informed consents."}, 'identificationModule': {'nctId': 'NCT06285734', 'briefTitle': 'Clinical Characteristics of Small Intestinal Bacterial Overgrowth in Individuals with Abdominal Distention', 'organization': {'class': 'OTHER', 'fullName': 'Shandong University'}, 'officialTitle': 'Clinical Characteristics of Small Intestinal Bacterial Overgrowth in Individuals with Abdominal Distention', 'orgStudyIdInfo': {'id': 'KYLL-202312-049'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Breath test', 'type': 'DIAGNOSTIC_TEST', 'description': 'The concentration of methane and hydrogen in the exhaled gas of patients with Abdominal distention is measured by a breath test to determine the presence of SIBO and abnormal OCTT.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '250012', 'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Professor Zuo', 'role': 'CONTACT', 'email': 'lcyxwxq@163.com', 'phone': '15662699906'}], 'facility': 'Gastroenterology Department of Qilu Hospital', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'centralContacts': [{'name': 'Xiuli Zuo, MD,PhD', 'role': 'CONTACT', 'email': 'zuoxiuli@sdu.edu.cn', 'phone': '15588818685'}], 'overallOfficials': [{'name': 'Feixue Chen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Qilu Hospital of Shandong University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shandong University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Qilu Hospital of Shandong University (Qingdao)', 'class': 'OTHER'}, {'name': 'Jinan Central Hospital', 'class': 'OTHER'}, {'name': 'Zaozhuang Municipal Hospital', 'class': 'OTHER'}, {'name': 'Weihai Municipal Hospital', 'class': 'OTHER'}, {'name': 'Central Hospital of Zibo', 'class': 'OTHER'}, {'name': "Weifang People's Hospital", 'class': 'OTHER'}, {'name': 'Dezhou Hospital Qilu Hospital of Shandong University', 'class': 'OTHER'}, {'name': 'Binzhou Medical University', 'class': 'OTHER'}, {'name': 'Qihe Xian Renmin Hospital', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Director of gastroenterology department of Qilu hospital', 'investigatorFullName': 'Xiuli Zuo', 'investigatorAffiliation': 'Shandong University'}}}}