Ignite Creation Date:
2025-12-25 @ 3:16 AM
Ignite Modification Date:
2025-12-26 @ 1:55 AM
Study NCT ID:
NCT05810805
Status:
UNKNOWN
Last Update Posted:
2023-04-12
First Post:
2023-02-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Measurement and Analysis of Gas Composition in Digestive Tract
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D043183', 'term': 'Irritable Bowel Syndrome'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D003109', 'term': 'Colonic Diseases, Functional'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 460}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2024-03-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-31', 'studyFirstSubmitDate': '2023-02-13', 'studyFirstSubmitQcDate': '2023-03-31', 'lastUpdatePostDateStruct': {'date': '2023-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Concentrations of different gas in digestive tract', 'timeFrame': 'immediately after the procedure', 'description': 'Concentrations of H2, CH4, NO and H2S in various parts of digestive tract'}], 'secondaryOutcomes': [{'measure': 'Correlation between digestive tract and breath test', 'timeFrame': 'Immediately after the procedure', 'description': 'Correlation between concentration levels of H2, CH4, NO and H2S in various parts of digestive tract and breath test'}, {'measure': 'Differences in concentrations of H2, CH4, NO, and H2S in the digestive tract between patients with different gastrointestinal diseases and normal individuals.', 'timeFrame': 'Immediately after the procedure', 'description': "The diagnosis of imflammtory bowel disease, irritable bowel syndrome, colorectal neoplasms, helicobacter pylori infection and functional dyspepia refer to Chinese guidelines or expert consensus. The gas sample will be taken through the biopsy port during endoscopy. The concentration of H2, CH4, NO and H2S will be assessed by chemical gas sensor. The measured concentration of H2 and CH4 is one part per million(ppm). For NO and H2S, the measured concentration is one part per billion (ppb). For different disease groups, the difference between the control groups and the disease group will be analyzed with Student's t test or Mann-Whitney U test."}, {'measure': 'The correlation between the severity of gastrointestinal symptoms and gas concentrations in various parts of the digestive tract.', 'timeFrame': 'Immediately after the procedure', 'description': 'The symptoms will be assessed by Gastrointestinal Symptom-Rating Scale (GSRS) scores. The gas sample will be taken through the biopsy port during endoscopy. The concentration of H2, CH4, NO and H2S will be assessed by chemical gas sensor. The measured concentration of H2 and CH4 is one part per million(ppm). For NO and H2S, the measured concentration is one part per billion (ppb). The Spearman correlation will be used to determine the correlation between the severity of gastrointestinal symptoms and different gas concentration.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Inflammatory Bowel Diseases', 'Irritable Bowel Syndrome', 'Functional Dyspepsia', 'Colorectal Neoplasms', 'Helicobacter Pylori Infection']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to detect the concentration of various gases，including hydrogen, methane, hydrogen sulfide, nitric oxide in different parts of the digestive tract by a safe and direct method, and to establish a human digestive tract gas profiles. Analyze the differences in gas components in different segments of the digestive tract in patients with different diseases, and analyze the correlation between specific gases and digestive tract diseases and non-specific symptoms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing endoscopy at Qilu Hospital of Shandong University', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 18 to 70 years.\n* Patients undergoing endoscopic examination\n\nExclusion Criteria:\n\n* Patients with serious underlying diseases, such as liver insufficiency, renal insufficiency, immunosuppression, coronary heart disease (angina pectoris or coronary artery stenosis ≥ 75%).\n* Patients have history of gastrointestinal surgery\n* Patients who failed to complete the endoscopic examination due to various reasons\n* Patients Boston score of Bowel preparation≤ 6 points\n* Patients who have medication history of probiotics, antibiotics, PPIs and prokinetic drugs in the last 4 weeks\n* Patients who combined with thyroid disease and other diseases that affect gastrointestinal motility\n* Patients who combined with other risk factors such as mental illness, alcoholism, and drug abuse\n* Patients who unable or unwilling to provide informed consent'}, 'identificationModule': {'nctId': 'NCT05810805', 'briefTitle': 'Measurement and Analysis of Gas Composition in Digestive Tract', 'organization': {'class': 'OTHER', 'fullName': 'Shandong University'}, 'officialTitle': 'Measurement and Analysis of Gas Composition in Digestive Tract: a Prospective, Single-center Observational Study', 'orgStudyIdInfo': {'id': '2023SDU-QILU-G001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control group', 'interventionNames': ['Other: gas component of digestive tract']}, {'label': 'Imflammtory bowel disease group', 'interventionNames': ['Other: gas component of digestive tract']}, {'label': 'Irritable bowel syndrome group', 'interventionNames': ['Other: gas component of digestive tract']}, {'label': 'Colorectal neoplasms group', 'interventionNames': ['Other: gas component of digestive tract']}, {'label': 'Helicobacter pylori infection group', 'interventionNames': ['Other: gas component of digestive tract']}, {'label': 'functional dyspepia group', 'interventionNames': ['Other: gas component of digestive tract']}], 'interventions': [{'name': 'gas component of digestive tract', 'type': 'OTHER', 'description': 'Analyze the differences in gas components in different segments of the digestive tract in patients with different diseases, and analyze the correlation between specific gases and digestive tract diseases and non-specific symptoms.', 'armGroupLabels': ['Colorectal neoplasms group', 'Control group', 'Helicobacter pylori infection group', 'Imflammtory bowel disease group', 'Irritable bowel syndrome group', 'functional dyspepia group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '250012', 'city': 'Jinan', 'state': 'Shandong', 'country': 'China', 'facility': 'Qilu Hospital, Shandong University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xiuli Zuo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'director of Qilu Hospital gastroenterology department', 'investigatorFullName': 'Xiuli Zuo', 'investigatorAffiliation': 'Shandong University'}}}}