Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2025-12-30 @ 7:41 AM
Study NCT ID:
NCT06268834
Status:
COMPLETED
Last Update Posted:
2024-02-20
First Post:
2024-02-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Is Long-Term Proton Pump Inhibitor Use a Cause of Leaky Gut Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel Assignment'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-19', 'studyFirstSubmitDate': '2024-02-13', 'studyFirstSubmitQcDate': '2024-02-19', 'lastUpdatePostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Zonulin levels in long-term proton pump inhibitor users', 'timeFrame': 'Blood was drawn and collected during the examination and studied collectively after 3 months', 'description': "Approximately 5 cc of blood was drawn from the antebrachial veins of the patients to determine serum zonulin levels. Serum örnekleri -80 santigrat derecede 3 ay süreyle saklanmıştır. Serum örneklerindeki Zonulin seviyeleri Shanghai Crystal Day Biotech Co, Ltd, Shanghai, Çin'den ticari BT-LAB Human Zonulin ELISA kitleri (Kat. No. E1117Hu) kullanılarak ölçülmüştür. The test range of the kit was 2-600 ng/ml. The sensitivity of the test was 1.09 ng/ml. A serum zonulin level above 12 ng/ml was considered positive."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Proton Pump Inhibitor Adverse Reaction']}, 'referencesModule': {'references': [{'pmid': '16265432', 'type': 'BACKGROUND', 'citation': 'Fasano A, Shea-Donohue T. Mechanisms of disease: the role of intestinal barrier function in the pathogenesis of gastrointestinal autoimmune diseases. Nat Clin Pract Gastroenterol Hepatol. 2005 Sep;2(9):416-22. doi: 10.1038/ncpgasthep0259.'}, {'pmid': '12404235', 'type': 'BACKGROUND', 'citation': 'El Asmar R, Panigrahi P, Bamford P, Berti I, Not T, Coppa GV, Catassi C, Fasano A. Host-dependent zonulin secretion causes the impairment of the small intestine barrier function after bacterial exposure. Gastroenterology. 2002 Nov;123(5):1607-15. doi: 10.1053/gast.2002.36578.'}, {'pmid': '29658189', 'type': 'BACKGROUND', 'citation': 'Haastrup PF, Thompson W, Sondergaard J, Jarbol DE. Side Effects of Long-Term Proton Pump Inhibitor Use: A Review. Basic Clin Pharmacol Toxicol. 2018 Aug;123(2):114-121. doi: 10.1111/bcpt.13023. Epub 2018 May 24.'}]}, 'descriptionModule': {'briefSummary': 'Our study aims to investigate the effect of bacterial overgrowth induced by long-term PPI use on zonulin levels.', 'detailedDescription': 'The study included a total of 75 participants, with 45 individuals classified as long-term PPI users and 30 as non-PPI users. The PPI user group was defined as those who had been consistently using PPIs (specifically omeprazole, lansoprazole, pantoprazole, esomeprazole, or rabeprazole) on a daily basis for a minimum of 6 months or at least twice a week for a minimum of 2 years. The control group comprised individuals who had never used PPIs. Venous blood samples were taken from all participants to measure serum zonulin levels.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nThe patient group was patients taking long-term PPIs (omeprazole, lansoprazole, pantoprazole, esomeprazole and rabeprazole) every day for at least 6 months or at least twice a week for at least 2 years.\n\nA control group was formed from individuals who had never used PPI.\n\nExclusion Criteria:\n\nThose with inflammatory bowel disease, celiac disease, type 1 diabetes, active gastroenteritis, acute kidney failure, chronic kidney failure, and those who had used antibiotics for any reason in the last 3 months, as well as those receiving probiotic drug support, were not included in the study\n\n\\-'}, 'identificationModule': {'nctId': 'NCT06268834', 'briefTitle': 'Is Long-Term Proton Pump Inhibitor Use a Cause of Leaky Gut Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital'}, 'officialTitle': 'Is Long-Term Proton Pump Inhibitor Use a Cause of Leaky Gut Syndrome: A Cross-Sectional Case-Control Study', 'orgStudyIdInfo': {'id': 'ZonulinPPI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Using PPI', 'description': 'Group receiving a long-term PPI (omeprazole, lansoprazole, pantoprazole, esomeprazole and rabeprazole) every day for at least 6 months or at least twice a week for at least 2 years.', 'interventionNames': ['Diagnostic Test: Blood for zonulin level was drawn from the group.']}, {'type': 'EXPERIMENTAL', 'label': 'Control', 'description': 'A control group was formed from individuals who had never used PPI.', 'interventionNames': ['Diagnostic Test: Blood for zonulin level was drawn from the group.']}], 'interventions': [{'name': 'Blood for zonulin level was drawn from the group.', 'type': 'DIAGNOSTIC_TEST', 'description': 'Serum zonulin levels were determined by taking 5 cc blood from the antebrachial veins of the patients.', 'armGroupLabels': ['Control', 'Using PPI']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'clinic physician', 'investigatorFullName': 'Semih Sezer', 'investigatorAffiliation': 'Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital'}}}}