Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2026-03-07 @ 5:59 PM
Study NCT ID:
NCT03166605
Status:
UNKNOWN
Last Update Posted:
2018-06-26
First Post:
2017-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ingestion of Simethicone After Capsule Ingestion and Its Impact on Quality of Video Capsule Endoscopy- a Pilot Study
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': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Randomized control'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Control, Sham , Experimental'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-05-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2019-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-06-25', 'studyFirstSubmitDate': '2017-05-23', 'studyFirstSubmitQcDate': '2017-05-23', 'lastUpdatePostDateStruct': {'date': '2018-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Small bowel visualization quality (SBVQ)', 'timeFrame': '8 hours'}], 'secondaryOutcomes': [{'measure': 'Small bowel transit time (SBTT),', 'timeFrame': '8 hours'}, {'measure': 'Diagnostic yield (DY)', 'timeFrame': '8 hours'}, {'measure': 'completion rate (CR)', 'timeFrame': '8 hours'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Video Capsule Endoscopy']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Does purgative preparation influence the diagnostic yield of small bowel video capsule endoscopy?: A meta-analysis. Rokkas T, Papaxoinis K, Triantafyllou K, Pistiolas D, Ladas SD Am J Gastroenterol. 2009;104(1):219. Purgative bowel cleansing combined with simethicone improves capsule endoscopy imaging. Wei W, Ge ZZ, Lu H, Gao YJ, Hu YB, Xiao SD Am J Gastroenterol. 2008;103(1):77. Investigation of colonic and whole-gut transit with wireless motility capsule and radiopaque markers in constipation.Rao SS, Kuo B, McCallum RW, Chey WD, DiBaise JK, Hasler WL, Koch KL, Lackner JM, Miller C, Saad R, Semler JR, Sitrin MD, Wilding GE, Parkman HP Clin Gastroenterol Hepatol. 2009;7(5):537. Optimal Bowel Preparation for Video Capsule Endoscopy. Hyun Joo Song, Jeong Seop Moon, and Ki-Nam Shim. Gastroenterology Research and Practice, vol. 2016, Article ID 6802810, 7 pages, 2016. doi:10.1155/2016/6802810 Simethicone for small bowel preparation for capsule endoscopy: a systematic, single-blinded, controlled study. Albert J, Göbel CM, Lesske J, Lotterer E, Nietsch H, Fleig WE Gastrointest Endosc. 2004;59(4):487 Small bowel preparations for capsule endoscopy with mannitol and simethicone: a prospective, randomized, clinical trial. Chen HB, Huang Y, Chen SY, Song HW, Li XL, Dai DL, Xie JT, He S, Zhao YY, Huang C, Zhang SJ, Yang LN J Clin Gastroenterol. 2011;45(4):337.'}, {'pmid': '18005366', 'type': 'RESULT', 'citation': 'Wei W, Ge ZZ, Lu H, Gao YJ, Hu YB, Xiao SD. Purgative bowel cleansing combined with simethicone improves capsule endoscopy imaging. Am J Gastroenterol. 2008 Jan;103(1):77-82. doi: 10.1111/j.1572-0241.2007.01633.x. Epub 2007 Nov 15.'}, {'pmid': '19418602', 'type': 'RESULT', 'citation': 'Rao SS, Kuo B, McCallum RW, Chey WD, DiBaise JK, Hasler WL, Koch KL, Lackner JM, Miller C, Saad R, Semler JR, Sitrin MD, Wilding GE, Parkman HP. Investigation of colonic and whole-gut transit with wireless motility capsule and radiopaque markers in constipation. Clin Gastroenterol Hepatol. 2009 May;7(5):537-44. doi: 10.1016/j.cgh.2009.01.017.'}, {'pmid': '26880894', 'type': 'RESULT', 'citation': 'Song HJ, Moon JS, Shim KN. Optimal Bowel Preparation for Video Capsule Endoscopy. Gastroenterol Res Pract. 2016;2016:6802810. doi: 10.1155/2016/6802810. Epub 2015 Dec 31.'}, {'pmid': '15044883', 'type': 'RESULT', 'citation': 'Albert J, Gobel CM, Lesske J, Lotterer E, Nietsch H, Fleig WE. Simethicone for small bowel preparation for capsule endoscopy: a systematic, single-blinded, controlled study. Gastrointest Endosc. 2004 Apr;59(4):487-91. doi: 10.1016/s0016-5107(04)00003-3.'}, {'pmid': '20871410', 'type': 'RESULT', 'citation': 'Chen HB, Huang Y, Chen SY, Song HW, Li XL, Dai DL, Xie JT, He S, Zhao YY, Huang C, Zhang SJ, Yang LN. Small bowel preparations for capsule endoscopy with mannitol and simethicone: a prospective, randomized, clinical trial. J Clin Gastroenterol. 2011 Apr;45(4):337-41. doi: 10.1097/MCG.0b013e3181f0f3a3.'}]}, 'descriptionModule': {'briefSummary': 'Wireless video capsule endoscopy (VCE) is a non-invasive technology that looks into small intestine and gives images of its lumen as the wireless capsule passes through it. It is used widely to access this anatomically difficult part of the body that cannot be seen via either colonoscopy or endoscopy. Currently various studies have been done that give multiple comparisons between various bowel preparation in terms of quality of the small bowel visualization. No studies have been done where simethicone (Gas-X) is ingested after capsule swallowing. We intend to give patients simethicone 1 hour after capsule ingestion for two consecutive hours and compare results of capsule endoscopy outcomes like small bowel transit time (SBTT), diagnostic yield (DY), small bowel visualization quality (SBVQ) and completion rate (CR).', 'detailedDescription': "Currently various studies have been done that give multiple comparisons between various bowel preparation in terms of small bowel transit time (SBTT), diagnostic yield (DY), small bowel visualization quality (SBVQ), completion rate (CR). Studies suggest that using Polyethylene glycol (PEG) prep is significantly better compared to clear liquid and overnight fast in terms if SBVQ and DY (Rokkas et al 2009). Other studies have shown using simethicone 30 minutes before capsule ingestion increases visibility compared to clear liquid and PEG preparation but no significant difference in gastrointestinal transit time or examination completion rate (Wei et al 2008). No studies have been done where simethicone is ingested after capsule swallowing.\n\nSimethicone helps absorb the air bubble in the lumen which can improve the image quality. It decreases the surface tension of gas bubbles thereby dissolving them and preventing gas pockets from forming in GI system. It's often used over the counter for gas relief. Gastric emptying time is usually less than 5 hours, small bowel transit time is usually less than 6 hours, and colonic transit time is usually less than 59 hours (Rao et al 2009). Giving simethicone till 2 hours after swallowing capsule can help clear gas bubble before the capsule migrates into the small bowel.\n\nAlbert et al 2004 gave patients 80mg simethicone before swallowing the wireless capsule for their study. Wei et al 2008 gave 300mg of simethicone 20 minutes before swallowing the capsule. Chen et al 2011 gave 20ml (40mg/ml) simethicone 30 minutes before capsule ingestion which amounts to 800 mg total. Current FDA recommendation for adults is 500mg maximum daily dose. The liquid form comes in concentration of 20mg/0.3ml which constitutes to 7.5 ml for 500mg dose."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients aged 18 and older\n* patients undergoing capsule endoscopy for standard of care\n* patients able to give consent for themselves\n\nExclusion Criteria:\n\n• prisoners'}, 'identificationModule': {'nctId': 'NCT03166605', 'briefTitle': 'Ingestion of Simethicone After Capsule Ingestion and Its Impact on Quality of Video Capsule Endoscopy- a Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'Albany Medical College'}, 'officialTitle': 'Ingestion of Simethicone After Capsule Ingestion and Its Impact on Quality of Video Capsule Endoscopy- a Pilot Study', 'orgStudyIdInfo': {'id': '4849'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'First group: Control\n\nFollow the current standard protocol used at Albany Medical Center that includes:\n\n* Do not drink anything for an additional 2 hours after swallowing pill cam. After which patient may drink clear liquids\n* Do not eat solid food until 4 hours after swallowing. After which patient may eat light that includes soup, toast.\n* Return to clinic (RTC) 8 hours after to remove equipment\n* Avoid carbonated beverages and gas forming foods for the completion of the 8-hours study period'}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham', 'description': '* Receive 3 ml simethicone 20 minutes prior to capsule swallowing\n* Do not drink anything for an additional 2 hours after swallowing pill cam. After which patient may drink clear liquids\n* Do not eat solid food until 4 hours after swallowing. After which patient may eat light that includes soup, toast.\n* Return to clinic (RTC) 8 hours after to remove equipment\n* Avoid carbonated beverages and gas forming foods for the completion of the 8-hours study period.', 'interventionNames': ['Drug: Simethicone']}, {'type': 'EXPERIMENTAL', 'label': 'Experiment', 'description': '* Receive 3 ml simethicone 20 minutes prior to capsule swallowing.\n* Receive 3 ml simethicone 1 hours after capsule swallowing\n* Receive 1.5 ml simethicone 2 hours after capsule swallowing\n* Do not drink anything for an additional 1 hour after taking last simethicone dose. After which patient may drink clear liquids\n* Do not eat solid food until 4 hours after swallowing. After which patient may eat light that includes soup, toast.\n* Return to clinic (RTC) 8 hours after to remove equipment\n* Avoid carbonated beverages and gas forming foods for the completion of the 8-hours study period.', 'interventionNames': ['Drug: Simethicone']}], 'interventions': [{'name': 'Simethicone', 'type': 'DRUG', 'description': 'Giving simethicone before and after capsule ingestion.', 'armGroupLabels': ['Experiment', 'Sham']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12208', 'city': 'Albany', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Asra Batool, MD', 'role': 'CONTACT', 'email': 'batoola@mail.amc.edu', 'phone': '518-262-5276'}, {'name': 'Gurjiwan S Virk, MD', 'role': 'CONTACT', 'email': 'virkg@mail.amc.edu', 'phone': '2483202562'}], 'facility': 'Albany medical center', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}], 'centralContacts': [{'name': 'Marilyn Fisher, MD', 'role': 'CONTACT', 'email': 'irboard@mail.amc.edu', 'phone': '(518) 262-5182'}, {'name': 'Angela Sheehan, MS', 'role': 'CONTACT', 'email': 'sheehaa@mail.amc.edu', 'phone': '518-262-2475'}], 'overallOfficials': [{'name': 'Asra Batool, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Albany Medical College'}, {'name': 'Gurjiwan s Virk, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Albany Medical College'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Albany Medical College', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Resident Physician', 'investigatorFullName': 'Gurjiwan Virk', 'investigatorAffiliation': 'Albany Medical College'}}}}