Video Capsule EndoscopyNCT03166605
Ingestion of Simethicone After Capsule Ingestion and Its Impact on Quality of Video Capsule Endoscopy- a Pilot Study
A study testing Simethicone in people with Video Capsule Endoscopy, run by Albany Medical College at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Video Capsule Endoscopy
- What is being tested?
- Simethicone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 3 May 2017to Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients aged 18 and older
- patients undergoing capsule endoscopy for standard of care
- patients able to give consent for themselves
Who cannot join
- prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Albany medical center
Albany, New York, 12208
Asra Batool, MD, 518-262-5276, batoola@mail.amc.edu
Gurjiwan S Virk, MD, 2483202562, virkg@mail.amc.edu
About this study
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).
Read the 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.
- Conditions
- Video Capsule Endoscopy
- Being tested
- Simethicone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SimethiconeDrug
Giving simethicone before and after capsule ingestion.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Simethicone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Small bowel visualization quality (SBVQ)
Measured: 8 hours
Secondary outcomes (3)
Small bowel transit time (SBTT),
Measured: 8 hours
Diagnostic yield (DY)
Measured: 8 hours
completion rate (CR)
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2017
- Study start3 May 2017
- Primary completionMar 2019 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Video Capsule EndoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Control, Sham , Experimental
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Albany Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gurjiwan Virk, Albany Medical College
- Investigators
- Asra Batool, MD, Principal investigator, Albany Medical CollegeGurjiwan s Virk, MD, Principal investigator, Albany Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03166605
- Sponsor's protocol ID
- 4849
- Status last verified
- Jun 2018
- First submitted
- 23 May 2017
- Last updated
- 26 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
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.
PubMed 18005366Rao 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.
PubMed 19418602Song 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.
PubMed 26880894Albert 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.
PubMed 15044883Chen 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.
PubMed 20871410
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ingestion of Simethicone After Capsule Ingestion and Its Impact on Quality of Video Capsule Endoscopy- a Pilot Study
- ClinicalTrials.gov ID
- NCT03166605
- Acronym / sponsor ID
- 4849
- Conditions
- Video Capsule Endoscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Albany Medical CollegeUniversity, hospital or other
- Study start
- 3 May 2017 (actual)
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 25 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- Control, Sham , Experimental
| Arm | Type | Receives |
|---|---|---|
| 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 | Drug: Simethicone* 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. |
| Experiment | Experimental | Drug: Simethicone* 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients aged 18 and older
- patients undergoing capsule endoscopy for standard of care
- patients able to give consent for themselves
Key exclusion criteria (1 listed)
- prisoners
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SimethiconeGiving simethicone before and after capsule ingestion. | Drug | Experiment, Sham |
Primary outcome
Small bowel visualization quality (SBVQ)
Time frame: 8 hours
3 secondary outcomes
Small bowel transit time (SBTT),
Time frame: 8 hours
Diagnostic yield (DY)
Time frame: 8 hours
completion rate (CR)
Time frame: 8 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2018.
- Results publicationDoes 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.
- Results publication: PubMed 18005366Wei 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.
- Results publication: PubMed 19418602Rao 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.
- Results publication: PubMed 26880894Song 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.
- Results publication: PubMed 15044883Albert 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.
- Results publication: PubMed 20871410Chen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asra Batool, MD principal investigator
Albany Medical College
Gurjiwan s Virk, MD principal investigator
Albany Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simethicone in people with Video Capsule Endoscopy, run by Albany Medical College at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marilyn Fisher, MD ((518) 262-5182, irboard@mail.amc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Small bowel visualization quality (SBVQ) (time frame: 8 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03166605, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2018.