Recruiting

Simethicone

Sponsor:

Albany Medical College

Code:

NCT03166605

Conditions

Video Capsule Endoscopy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Simethicone

Study Details

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

Study ID

NCT03166605

Start date

May 3, 2017

Status verified date

Jun, 2018

Completion date

Jun, 2019

Anticipated

Primary completion date

Mar, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

36 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Simethicone

Giving simethicone before and after capsule ingestion.

Primary outcome measure

  • Small bowel visualization quality (SBVQ) [ Time Frame: 8 hours ]

Central Contacts and Locations

Central contacts

Marilyn Fisher, MD

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

Angela Sheehan, MS

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

Locations

Albany medical center

Recruiting

Albany, New York, United States, 12208

Contacts

Asra Batool, MD

518-262-5276batoola@mail.amc.edu

Gurjiwan S Virk, MD

2483202562virkg@mail.amc.edu

More Information

Sponsor

Albany Medical College

Last update posted

Jun 26, 2018

Last verified

Jun, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Albany Medical College on 2018-06-26.