Slow TransitNCT02353208

The Effect of Sham Feeding on Small Bowel Transit Time in Patients Undergoing Capsule Endoscopy

A study of Slow Transit, run by University of British Columbia at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 19 years and olderHealthy volunteers can take part
Conditions the study is for: Slow Transit
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 122 participants
Where: 1 siteCanada
Study dates: Jan 2015to May 2017
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 19 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Out-patients, 19 years or older referred to St. Paul's Hospital for capsule endoscopy

Who cannot join

In-patients will be excluded
Patients who have been taking taken medications that affect your bowel movement in the five days prior to the procedure
Patients who are vegetarian or have dietary restrictions that do not allow bacon/pork products.
Patients, who have proven or suspected obstruction of the bowel.
Patients, who have had prior small bowel and/or stomach surgery.
Patients who have a known and/or have a history suggestive of a swallowing disorder

Show all 10Show fewer

Patients with complicated diabetes diabetes with associated complications (bleeding in eyes, kidney disease, or numbness/tingling in hands/feet)
Patient who have thyroid problem that is not being treated (for example, hypothyroid but not taking supplement)
Patients who are pregnant, prisoners or an institutionalized individuals
Patients whose capsule camera is placed using a traditional scope (instead of swallowing the capsule camera)

Trial locations and contacts

1 site in 1 country.

Canada1 site

GI Clinic, St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6

Other trials in Canada

About this study

Official title: The Effect of Sham Feeding on Small Bowel Transit Time in Patients Undergoing Capsule Endoscopy: a Prospective Randomized Trial

Capsule endoscopy is a non-invasive way to examine the small bowel, but its yield is limited by the battery life. In 20% of cases, the recording stops before the entire length of small bowel is examined. Capsule transit speed is dependent on bowel motility. When we eat, the brain sends signal to the bowel to speed up motility. In this study the investigators wish to determine if chewing bacon (sham feeding) can trick the brain to speed up bowel motility and improve the rate of complete small bowel examination.

Read the detailed description

This is a prospective, randomized, single-blinded controlled trial.

Subjects ages 19 years and older referred for capsule endoscopy (CE) at the GI Clinic, St. Paul's Hospital will be invited to participate in the study. We will be recruiting 122 subjects and will randomize them into 2 groups: control group and treatment group. Control subjects will undergo the standard capsule endoscopy procedure. Subjects in Treatment group will undergo sham feeding in addition to the standard capsule endoscopy procedure. Both control and treatment subjects in this study will be required to swallow a capsule (the size of a large pill) named Given Imaging SB3® Capsule.

The investigator and the video reader will be blinded (single-blinded study). Times will be recorded at: first gastric image, first duodenal image and first cecal image.

The diagnostic yield for controls and subjects will be calculated. The clarity of the images will be graded according to the ICCE 2005 consensus regarding bowel preparation and prokinetics in capsule endoscopy.

Conditions: Slow Transit
Being tested: Sham Feeding of Bacon Bits, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Sham Feeding of Bacon BitsOther
Also called Bacon bits
Bacon bits will be a commercially available produce which has been deemed safe for sale in Canada.
PlaceboOther
Also called Control
Participants will not be asked to chew bacon bits

Study groups in NCT02353208
Study group	Role	What they receive
Sham Feeding of Bacon Bits	Active comparator	In addition to the standard procedure, subjects will be asked to perform sham feeding on two occasions: 1) Immediately after having swallowed the capsule and 2) One hour after having swallowed the capsule. Sham feeding will be performed as follows: The patients will be asked to chew 10 times on a piece of bacon over a period of 30 seconds, prior to spitting saliva and bacon into a container. This will be repeated 10 times at one minute intervals. The patient will then complete the capsule study as per the standard procedure. Bacon bits will be a commercially available produce which has been deemed safe for sale in Canada. Receives: Other: Sham Feeding of Bacon Bits
Placebo	Placebo comparator	The control group will not chew bacon bits while undergoing capsule endoscopy. Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Small bowel transit time
To investigate whether sham feeding using bacon shortens small bowel transit time (SBTT)
Measured: 5 hours

Secondary outcomes (3)

Gastric transit time
To investigate whether sham feeding shortens gastric transit time (GTT)
Measured: 1 hour
Diagnostic yield of capsule endoscopy
To investigate whether sham feeding alters clarity of the capsule endoscopy images.
Measured: 5 hours
Completion examination rate
To investigate whether sham feeding using bacon increases the completion examination rate (CER)
Measured: 8 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2015May 2017

First posted2 Feb 2015 (estimated)
Study startJan 2015
Primary completion16 Nov 2016
Study completionMay 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (27)Papers the sponsor has linked to this study.
Other trials for Slow TransitStudies of the same condition, open and under way.
More trials run by University of British ColumbiaThe sponsor's other registered studies.
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
Masking: Single blind
Who is masked: Investigator
Enrolment: 122 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02353208
Sponsor's protocol ID: H14-03443
Status last verified: Dec 2017
First submitted: 12 Jan 2015
Last updated: 27 Dec 2017
Results posted: No
Data monitoring committee: No

Publications

ASGE Technology Committee; Wang A, Banerjee S, Barth BA, Bhat YM, Chauhan S, Gottlieb KT, Konda V, Maple JT, Murad F, Pfau PR, Pleskow DK, Siddiqui UD, Tokar JL, Rodriguez SA. Wireless capsule endoscopy. Gastrointest Endosc. 2013 Dec;78(6):805-815. doi: 10.1016/j.gie.2013.06.026. Epub 2013 Oct 8.
PubMed 24119509
Pasha SF, Leighton JA, Das A, Harrison ME, Decker GA, Fleischer DE, Sharma VK. Double-balloon enteroscopy and capsule endoscopy have comparable diagnostic yield in small-bowel disease: a meta-analysis. Clin Gastroenterol Hepatol. 2008 Jun;6(6):671-6. doi: 10.1016/j.cgh.2008.01.005. Epub 2008 Mar 20.
PubMed 18356113
Iaquinto G, Fornasarig M, Quaia M, Giardullo N, D'Onofrio V, Iaquinto S, Di Bella S, Cannizzaro R. Capsule endoscopy is useful and safe for small-bowel surveillance in familial adenomatous polyposis. Gastrointest Endosc. 2008 Jan;67(1):61-7. doi: 10.1016/j.gie.2007.07.048.
PubMed 18155426
Marmo R, Rotondano G, Piscopo R, Bianco MA, Cipolletta L. Meta-analysis: capsule enteroscopy vs. conventional modalities in diagnosis of small bowel diseases. Aliment Pharmacol Ther. 2005 Oct 1;22(7):595-604. doi: 10.1111/j.1365-2036.2005.02625.x.
PubMed 16181299
Schulmann K, Hollerbach S, Kraus K, Willert J, Vogel T, Moslein G, Pox C, Reiser M, Reinacher-Schick A, Schmiegel W. Feasibility and diagnostic utility of video capsule endoscopy for the detection of small bowel polyps in patients with hereditary polyposis syndromes. Am J Gastroenterol. 2005 Jan;100(1):27-37. doi: 10.1111/j.1572-0241.2005.40102.x.
PubMed 15654777
Triester SL, Leighton JA, Leontiadis GI, Fleischer DE, Hara AK, Heigh RI, Shiff AD, Sharma VK. A meta-analysis of the yield of capsule endoscopy compared to other diagnostic modalities in patients with obscure gastrointestinal bleeding. Am J Gastroenterol. 2005 Nov;100(11):2407-18. doi: 10.1111/j.1572-0241.2005.00274.x.
PubMed 16279893
Caddy GR, Moran L, Chong AK, Miller AM, Taylor AC, Desmond PV. The effect of erythromycin on video capsule endoscopy intestinal-transit time. Gastrointest Endosc. 2006 Feb;63(2):262-6. doi: 10.1016/j.gie.2005.07.043.
PubMed 16427932
Postgate A, Tekkis P, Patterson N, Fitzpatrick A, Bassett P, Fraser C. Are bowel purgatives and prokinetics useful for small-bowel capsule endoscopy? A prospective randomized controlled study. Gastrointest Endosc. 2009 May;69(6):1120-8. doi: 10.1016/j.gie.2008.06.044. Epub 2009 Jan 18.
PubMed 19152909
Rondonotti E, Herrerias JM, Pennazio M, Caunedo A, Mascarenhas-Saraiva M, de Franchis R. Complications, limitations, and failures of capsule endoscopy: a review of 733 cases. Gastrointest Endosc. 2005 Nov;62(5):712-6; quiz 752, 754. doi: 10.1016/j.gie.2005.05.002.
PubMed 16246685
Westerhof J, Weersma RK, Koornstra JJ. Risk factors for incomplete small-bowel capsule endoscopy. Gastrointest Endosc. 2009 Jan;69(1):74-80. doi: 10.1016/j.gie.2008.04.034. Epub 2008 Aug 8.
PubMed 18691709
Aparicio JR, Martinez J, Casellas JA. Right lateral position does not affect gastric transit times of video capsule endoscopy: a prospective study. Gastrointest Endosc. 2009 Jan;69(1):34-7. doi: 10.1016/j.gie.2008.03.1111. Epub 2008 Jul 11.
PubMed 18620344
Liao Z, Li F, Li ZS. Right lateral position improves complete examination rate of capsule endoscope: a prospective randomized, controlled trial. Endoscopy. 2008 Jun;40(6):483-7. doi: 10.1055/s-2007-995689.
PubMed 18556803
Koulaouzidis A, Giannakou A, Yung DE, Dabos KJ, Plevris JN. Do prokinetics influence the completion rate in small-bowel capsule endoscopy? A systematic review and meta-analysis. Curr Med Res Opin. 2013 Sep;29(9):1171-85. doi: 10.1185/03007995.2013.818532. Epub 2013 Jul 11.
PubMed 23790243
Power ML, Schulkin J. Anticipatory physiological regulation in feeding biology: cephalic phase responses. Appetite. 2008 Mar-May;50(2-3):194-206. doi: 10.1016/j.appet.2007.10.006. Epub 2007 Oct 24.
PubMed 18045735
Defilippi C, Valenzuela JE. Sham feeding disrupts the interdigestive motility complex in man. Scand J Gastroenterol. 1981;16(8):977-9. doi: 10.3109/00365528109181014.
PubMed 7336138

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Efficacy and Safety of Lubiprostone in the Treatment of Slow Transit Constipation
Slow Transit Constipation, Pharmacotherapy
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STOPS Trial: Total vs Subtotal Colectomy for Slow Transit Constipation
Slow Transit Constipation, Surgery
Not yet recruitingObservational study
Preoperative Fish Oil PN and Prognosis After Constipation Surgery
Constipation, Slow Transit Constipation
Recruiting
MSOT and MRI for Non-invasive Assessment of Intestinal Transit Time in Children With Chronic Bowel Emptying Disorders
Chronic Constipation, Slow Transit Constipation

All Slow Transit trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Sham Feeding on Small Bowel Transit Time in Patients Undergoing Capsule Endoscopy: a Prospective Randomized Trial
ClinicalTrials.gov ID: NCT02353208
Acronym / sponsor ID: H14-03443
Conditions: Slow Transit
Study type: Interventional
Recruitment status: Completed
Enrolment: 122 participants (actual)
Lead sponsor: University of British ColumbiaUniversity, hospital or other
Study start: Jan 2015
Primary completion: 16 Nov 2016 (actual)
Study completion: May 2017 (actual)
First posted: 2 Feb 2015 (estimated)
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.

Detailed description

This is a prospective, randomized, single-blinded controlled trial.

The investigator and the video reader will be blinded (single-blinded study). Times will be recorded at: first gastric image, first duodenal image and first cecal image.

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
Sham Feeding of Bacon Bits	Active comparator	Other: Sham Feeding of Bacon BitsIn addition to the standard procedure, subjects will be asked to perform sham feeding on two occasions: 1) Immediately after having swallowed the capsule and 2) One hour after having swallowed the capsule. Sham feeding will be performed as follows: The patients will be asked to chew 10 times on a piece of bacon over a period of 30 seconds, prior to spitting saliva and bacon into a container. This will be repeated 10 times at one minute intervals. The patient will then complete the capsule study as per the standard procedure. Bacon bits will be a commercially available produce which has been deemed safe for sale in Canada.
Placebo	Placebo comparator	Other: PlaceboThe control group will not chew bacon bits while undergoing capsule endoscopy.

Who may qualify

Ages: 19 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Out-patients, 19 years or older referred to St. Paul's Hospital for capsule endoscopy

Key exclusion criteria (10 listed)

In-patients will be excluded
Patients who have been taking taken medications that affect your bowel movement in the five days prior to the procedure
Patients who are vegetarian or have dietary restrictions that do not allow bacon/pork products.
Patients, who have proven or suspected obstruction of the bowel.
Patients, who have had prior small bowel and/or stomach surgery.

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
Sham Feeding of Bacon BitsAlso: Bacon bitsBacon bits will be a commercially available produce which has been deemed safe for sale in Canada.	Other	Sham Feeding of Bacon Bits
PlaceboAlso: ControlParticipants will not be asked to chew bacon bits	Other	Placebo

Primary outcome

Small bowel transit time
Time frame: 5 hours
To investigate whether sham feeding using bacon shortens small bowel transit time (SBTT)

3 secondary outcomes

Gastric transit time
Time frame: 1 hour
Diagnostic yield of capsule endoscopy
Time frame: 5 hours
Completion examination rate
Time frame: 8 hours

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2017.
Background: PubMed 24119509ASGE Technology Committee; Wang A, Banerjee S, Barth BA, Bhat YM, Chauhan S, Gottlieb KT, Konda V, Maple JT, Murad F, Pfau PR, Pleskow DK, Siddiqui UD, Tokar JL, Rodriguez SA. Wireless capsule endoscopy. Gastrointest Endosc. 2013 Dec;78(6):805-815. doi: 10.1016/j.gie.2013.06.026. Epub 2013 Oct 8.
Background: PubMed 18356113Pasha SF, Leighton JA, Das A, Harrison ME, Decker GA, Fleischer DE, Sharma VK. Double-balloon enteroscopy and capsule endoscopy have comparable diagnostic yield in small-bowel disease: a meta-analysis. Clin Gastroenterol Hepatol. 2008 Jun;6(6):671-6. doi: 10.1016/j.cgh.2008.01.005. Epub 2008 Mar 20.
Background: PubMed 18155426Iaquinto G, Fornasarig M, Quaia M, Giardullo N, D'Onofrio V, Iaquinto S, Di Bella S, Cannizzaro R. Capsule endoscopy is useful and safe for small-bowel surveillance in familial adenomatous polyposis. Gastrointest Endosc. 2008 Jan;67(1):61-7. doi: 10.1016/j.gie.2007.07.048.
Background: PubMed 16181299Marmo R, Rotondano G, Piscopo R, Bianco MA, Cipolletta L. Meta-analysis: capsule enteroscopy vs. conventional modalities in diagnosis of small bowel diseases. Aliment Pharmacol Ther. 2005 Oct 1;22(7):595-604. doi: 10.1111/j.1365-2036.2005.02625.x.
Background: PubMed 15654777Schulmann K, Hollerbach S, Kraus K, Willert J, Vogel T, Moslein G, Pox C, Reiser M, Reinacher-Schick A, Schmiegel W. Feasibility and diagnostic utility of video capsule endoscopy for the detection of small bowel polyps in patients with hereditary polyposis syndromes. Am J Gastroenterol. 2005 Jan;100(1):27-37. doi: 10.1111/j.1572-0241.2005.40102.x.
Background: PubMed 16279893Triester SL, Leighton JA, Leontiadis GI, Fleischer DE, Hara AK, Heigh RI, Shiff AD, Sharma VK. A meta-analysis of the yield of capsule endoscopy compared to other diagnostic modalities in patients with obscure gastrointestinal bleeding. Am J Gastroenterol. 2005 Nov;100(11):2407-18. doi: 10.1111/j.1572-0241.2005.00274.x.
Background: PubMed 16427932Caddy GR, Moran L, Chong AK, Miller AM, Taylor AC, Desmond PV. The effect of erythromycin on video capsule endoscopy intestinal-transit time. Gastrointest Endosc. 2006 Feb;63(2):262-6. doi: 10.1016/j.gie.2005.07.043.
Background: PubMed 19152909Postgate A, Tekkis P, Patterson N, Fitzpatrick A, Bassett P, Fraser C. Are bowel purgatives and prokinetics useful for small-bowel capsule endoscopy? A prospective randomized controlled study. Gastrointest Endosc. 2009 May;69(6):1120-8. doi: 10.1016/j.gie.2008.06.044. Epub 2009 Jan 18.
Background: PubMed 16246685Rondonotti E, Herrerias JM, Pennazio M, Caunedo A, Mascarenhas-Saraiva M, de Franchis R. Complications, limitations, and failures of capsule endoscopy: a review of 733 cases. Gastrointest Endosc. 2005 Nov;62(5):712-6; quiz 752, 754. doi: 10.1016/j.gie.2005.05.002.
Background: PubMed 18691709Westerhof J, Weersma RK, Koornstra JJ. Risk factors for incomplete small-bowel capsule endoscopy. Gastrointest Endosc. 2009 Jan;69(1):74-80. doi: 10.1016/j.gie.2008.04.034. Epub 2008 Aug 8.
Background: PubMed 18620344Aparicio JR, Martinez J, Casellas JA. Right lateral position does not affect gastric transit times of video capsule endoscopy: a prospective study. Gastrointest Endosc. 2009 Jan;69(1):34-7. doi: 10.1016/j.gie.2008.03.1111. Epub 2008 Jul 11.
Background: PubMed 18556803Liao Z, Li F, Li ZS. Right lateral position improves complete examination rate of capsule endoscope: a prospective randomized, controlled trial. Endoscopy. 2008 Jun;40(6):483-7. doi: 10.1055/s-2007-995689.

Related trials for Slow Transit

RecruitingPhase 3
Efficacy and Safety of Lubiprostone in the Treatment of Slow Transit Constipation
Slow Transit Constipation, Pharmacotherapy
Active, not recruiting
STOPS Trial: Total vs Subtotal Colectomy for Slow Transit Constipation
Slow Transit Constipation, Surgery
Not yet recruitingObservational study
Preoperative Fish Oil PN and Prognosis After Constipation Surgery
Constipation, Slow Transit Constipation
Recruiting
MSOT and MRI for Non-invasive Assessment of Intestinal Transit Time in Children With Chronic Bowel Emptying Disorders
Chronic Constipation, Slow Transit Constipation

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.

Robert Enns, M.D. principal investigator

University of British Columbia

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study of Slow Transit, run by University of British Columbia at 1 site in Canada.

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 1 inclusion and 10 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: finished, as of the sponsor's last update on 27 Dec 2017. 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 Canada. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Small bowel transit time (time frame: 5 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 NCT02353208, which also lists 27 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 27 Dec 2017.