Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-26 @ 1:15 AM
Study NCT ID:
NCT07293234
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-19
First Post:
2025-12-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Simethicone on Helicobacter Pylori Detection in Routine Endoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D012841', 'term': 'Simethicone'}], 'ancestors': [{'id': 'D004129', 'term': 'Dimethylpolysiloxanes'}, {'id': 'D012828', 'term': 'Silicones'}, {'id': 'D012833', 'term': 'Siloxanes'}, {'id': 'D017646', 'term': 'Organosilicon Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-17', 'studyFirstSubmitDate': '2025-12-17', 'studyFirstSubmitQcDate': '2025-12-17', 'lastUpdatePostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in H.pylori Detection Rate by Rapid Urease Test before and After simethicone administration', 'timeFrame': 'Baseline ( prior to intervention ) and 30-60 minutes post- intervention (same day assessment during second endoscopy'}], 'secondaryOutcomes': [{'measure': 'Change in H.pylori Detection Rate by Histology, PCR, Culture, and Urea Breath Test before and After Simethicone or placebo', 'timeFrame': 'Baseline (pre -intervention) and 30-60 minutes post- intervention', 'description': 'This outcome measures the difference in detection rates of Helicobacter pylori using four additional diagnostic methods- histopathology , PCR, bacterial culture,and the urea breath test before and After administration of simethicone or placebo.The comparison will determine whether simethicone impacts these methgods similarly to RUT'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['H Pylori Infection']}, 'referencesModule': {'references': [{'pmid': '27548885', 'type': 'RESULT', 'citation': 'Bisschops R, Areia M, Coron E, Dobru D, Kaskas B, Kuvaev R, Pech O, Ragunath K, Weusten B, Familiari P, Domagk D, Valori R, Kaminski MF, Spada C, Bretthauer M, Bennett C, Senore C, Dinis-Ribeiro M, Rutter MD. Performance measures for upper gastrointestinal endoscopy: a European Society of Gastrointestinal Endoscopy (ESGE) Quality Improvement Initiative. Endoscopy. 2016 Sep;48(9):843-64. doi: 10.1055/s-0042-113128. Epub 2016 Aug 22. No abstract available.'}, {'pmid': '21826120', 'type': 'RESULT', 'citation': 'Ahsan M, Babaei L, Gholamrezaei A, Emami MH. Simethicone for the Preparation before Esophagogastroduodenoscopy. Diagn Ther Endosc. 2011;2011:484532. doi: 10.1155/2011/484532. Epub 2011 Aug 4.'}, {'pmid': '37854124', 'type': 'RESULT', 'citation': 'Beaufort IN, Verbeek RE, Bosman JH, Al-Toma A, Bogte A, Alvarez Herrero L, Weusten BLAM. Optimal timing of simethicone administration prior to upper endoscopy: A multicenter, single-blind, randomized controlled trial. Endosc Int Open. 2023 Oct 17;11(10):E992-E1000. doi: 10.1055/a-2157-5034. eCollection 2023 Oct.'}]}, 'descriptionModule': {'briefSummary': 'Rationale: Although simethicone improves mucosal clarity, in vitro evidence suggests that its surfactant properties may disrupt bacterial adherence or viability. These findings raise concerns that simethicone may negatively affect the sensitivity of endoscopic-based H. pylori diagnostic methods. To date, no prospective in vivo study has evaluated whether simethicone influences H. pylori detection through endoscopic sampling. This randomized paired trial is designed to address this gap in evidence and evaluate whether simethicone administration reduces diagnostic yield.\n\nHypothesis: We hypothesize that simethicone administration prior to upper gastrointestinal endoscopy may reduce the detection rate of H. pylori by interfering with bacterial detection and diagnostic test performance.\n\nNote on Pilot Study Design: This is a pilot study to test feasibility and inform the design of a larger future trial.\n\nObjectives :\n\nTo evaluate whether oral administration of simethicone prior to endoscopy reduces the diagnostic yield of H. pylori using rapid urease test (RUT) To evaluate whether oral administration of simethicone impacts the detection of H. pylori by other diagnostic methods, including histology, PCR, culture and Urea Breath Test performed during endoscopy.\n\nTo explore variability in detection methods and determine feasibility for a future larger trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 and \\<80 years RUT (Rapid Urease Test) positive on endoscopic biopsy. Able to provide informed consent\n\nExclusion Criteria:\n\n* Antibiotics or bismuth within 4 weeks PPIs within last 2 weeks H2 blockers within 72 hours History of previous gastric surgery On Anticoagulation Severe thrombocytopenia (Platelets \\<50,000/mm³) Severe comorbidities that contraindicate the administration of sedation Immunodeficiency Pregnancy Negative initial RUT or inability to consent'}, 'identificationModule': {'nctId': 'NCT07293234', 'briefTitle': 'Effect of Simethicone on Helicobacter Pylori Detection in Routine Endoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Asian Institute of Gastroenterology, India'}, 'officialTitle': 'Effect of Simethicone on Helicobacter Pylori Detection: A Paired, Randomized, Pilot Study in Routine Endoscopic Practice', 'orgStudyIdInfo': {'id': 'SIMPACT-HP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A (Simethicone Group)', 'interventionNames': ['Procedure: Simeticone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm B (Placebo Group)', 'interventionNames': ['Procedure: Simeticone']}], 'interventions': [{'name': 'Simeticone', 'type': 'PROCEDURE', 'description': 'Description: If the initial RUT (Rapid Urease Test) is positive. Randomization is done: Group A (will recevie simeticone), Group B (Placebo: will receive water). Group A: The patient receives 200 mL of oral simethicone (4 mg/mL). The preparation is: Each simethicone bottle contains 40 mg/mL in 10 mL volume (400 mg total per bottle). To prepare 1 liter of 4 mg/mL solution: we will take a 1 liter bottle of sterile water, aspirate and discard 100 mL, then add 10 bottles of simethicone (100 mL total volume containing 4000 mg). This creates 1000 mL of solution with a concentration of 4 mg/mL \\[8,9\\]. After 30-60 minutes, a second endoscopy is performed and biopsies are taken for RUT, culture, PCR, and histology. Group B: The patient receives 200 mL of plane water. After 30-60 minutes, a second endoscopy is performed and biopsies are taken for RUT, culture, PCR, and histology.', 'armGroupLabels': ['Arm A (Simethicone Group)', 'Arm B (Placebo Group)']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Dr.Aniruddha Pratap singh, MD, DM', 'role': 'CONTACT', 'email': 'Doc.aniruddha85@gmail.com', 'phone': '9004093248', 'phoneExt': '+91'}], 'overallOfficials': [{'name': 'Dr.Mohan Kumar Ramchandani, MD, DM', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AIG Hospitals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asian Institute of Gastroenterology, India', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, DM, FJGES , Director interventional Endoscopy , senior consultant Gastroenterologist', 'investigatorFullName': 'Mohan Ramchandani', 'investigatorAffiliation': 'Asian Institute of Gastroenterology, India'}}}}