Ingestion of Simethicone After Capsule Ingestion and Its Impact on Quality of Video Capsule Endoscopy- a Pilot Study

NCT03166605 | Unknown

• 1 other identifier: 4849
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Video Capsule Endoscopy

Outcome Measures

Primary Outcomes (1)

• Small bowel visualization quality (SBVQ)

  8 hours

Secondary Outcomes (3)

• Small bowel transit time (SBTT),

  8 hours

• Diagnostic yield (DY)

  8 hours

• completion rate (CR)

  8 hours

Study Arms (3)

Control

NO INTERVENTION

First group: Control Follow the current standard protocol used at Albany Medical Center that includes: * Do not drink anything for an additional 2 hours after swallowing pill cam. After which patient may drink clear liquids * Do not eat solid food until 4 hours after swallowing. After which patient may eat light that includes soup, toast. * Return to clinic (RTC) 8 hours after to remove equipment * Avoid carbonated beverages and gas forming foods for the completion of the 8-hours study period

Sham

SHAM COMPARATOR

* Receive 3 ml simethicone 20 minutes prior to capsule swallowing * Do not drink anything for an additional 2 hours after swallowing pill cam. After which patient may drink clear liquids * Do not eat solid food until 4 hours after swallowing. After which patient may eat light that includes soup, toast. * Return to clinic (RTC) 8 hours after to remove equipment * Avoid carbonated beverages and gas forming foods for the completion of the 8-hours study period.

Drug: Simethicone

Experiment

EXPERIMENTAL

* Receive 3 ml simethicone 20 minutes prior to capsule swallowing. * Receive 3 ml simethicone 1 hours after capsule swallowing * Receive 1.5 ml simethicone 2 hours after capsule swallowing * Do not drink anything for an additional 1 hour after taking last simethicone dose. After which patient may drink clear liquids * Do not eat solid food until 4 hours after swallowing. After which patient may eat light that includes soup, toast. * Return to clinic (RTC) 8 hours after to remove equipment * Avoid carbonated beverages and gas forming foods for the completion of the 8-hours study period.

Drug: Simethicone

Interventions

Simethicone DRUG

Giving simethicone before and after capsule ingestion.

Experiment; Sham

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients aged 18 and older
• patients undergoing capsule endoscopy for standard of care
• patients able to give consent for themselves

You may not qualify if:

• prisoners

Sponsors & Collaborators

• Albany Medical College: lead

Study Sites (1)

Albany medical center

Albany, New York, 12208, United States

RECRUITING

Related Publications (6)

• 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.

  RESULT

• 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: 18005366 RESULT

• 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: 19418602 RESULT

• 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: 26880894 RESULT

• 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: 15044883 RESULT

• 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.

  PMID: 20871410 RESULT

MeSH Terms

Interventions

Simethicone

Intervention Hierarchy (Ancestors)

Dimethylpolysiloxanes; Silicones; Siloxanes; Organosilicon Compounds; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Asra Batool, MD

  Albany Medical College

  PRINCIPAL INVESTIGATOR

• Gurjiwan s Virk, MD

  Albany Medical College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marilyn Fisher, MD

CONTACT

(518) 262-5182; irboard@mail.amc.edu

Angela Sheehan, MS

CONTACT

518-262-2475; sheehaa@mail.amc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Randomized control
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Resident Physician

Model Details: Control, Sham , Experimental

Study Record Dates

• First Submitted: May 23, 2017
• First Posted: May 25, 2017
• Study Start: May 3, 2017
• Primary Completion: March 1, 2019
• Study Completion: June 1, 2019
• Last Updated: June 26, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)