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

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ClinicalTrials.gov Identifier: NCT03166605
Recruitment Status : Unknown
Verified June 2018 by Gurjiwan Virk, Albany Medical College.
Recruitment status was:  Recruiting
First Posted : May 25, 2017
Last Update Posted : June 26, 2018
Sponsor:
Information provided by (Responsible Party):
Gurjiwan Virk, Albany Medical College

Study Description
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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).

Condition or disease Intervention/treatment Phase
Video Capsule Endoscopy Drug: Simethicone Not Applicable

Detailed Description:

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.

Simethicone 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.

Albert 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Control, Sham , Experimental
Masking: Double (Care Provider, Outcomes Assessor)
Masking Description: Randomized control
Primary Purpose: Diagnostic
Official Title: Ingestion of Simethicone After Capsule Ingestion and Its Impact on Quality of Video Capsule Endoscopy- a Pilot Study
Actual Study Start Date : May 3, 2017
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy
Drug Information available for: Simethicone

Arms and Interventions
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Arm Intervention/treatment
No Intervention: Control

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 Comparator: Sham
  • 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
Giving simethicone before and after capsule ingestion.
Experimental: Experiment
  • 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
Giving simethicone before and after capsule ingestion.


Outcome Measures
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Primary Outcome Measures :
  1. Small bowel visualization quality (SBVQ) [ Time Frame: 8 hours ]

Secondary Outcome Measures :
  1. Small bowel transit time (SBTT), [ Time Frame: 8 hours ]
  2. Diagnostic yield (DY) [ Time Frame: 8 hours ]
  3. completion rate (CR) [ Time Frame: 8 hours ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• prisoners

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03166605


Contacts
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Contact: Marilyn Fisher, MD (518) 262-5182 irboard@mail.amc.edu
Contact: Angela Sheehan, MS 518-262-2475 sheehaa@mail.amc.edu

Locations
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United States, New York
Albany medical center Recruiting
Albany, New York, United States, 12208
Contact: Asra Batool, MD    518-262-5276    batoola@mail.amc.edu   
Contact: Gurjiwan S Virk, MD    2483202562    virkg@mail.amc.edu   
Sponsors and Collaborators
Albany Medical College
Investigators
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Principal Investigator: Asra Batool, MD Albany Medical College
Principal Investigator: Gurjiwan s Virk, MD Albany Medical College
More Information
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Publications of Results:
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.

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Responsible Party: Gurjiwan Virk, MD, Resident Physician, Albany Medical College
ClinicalTrials.gov Identifier: NCT03166605    
Other Study ID Numbers: 4849
First Posted: May 25, 2017    Key Record Dates
Last Update Posted: June 26, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Simethicone
Antifoaming Agents
Molecular Mechanisms of Pharmacological Action
Emollients
Dermatologic Agents