Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Placebo | Placebo Comparator | The control group will not chew bacon bits while undergoing capsule endoscopy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sham Feeding of Bacon Bits | Other | Bacon bits will be a commercially available produce which has been deemed safe for sale in Canada. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Small bowel transit time | To investigate whether sham feeding using bacon shortens small bowel transit time (SBTT) | 5 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Gastric transit time | To investigate whether sham feeding shortens gastric transit time (GTT) | 1 hour |
| Diagnostic yield of capsule endoscopy | To investigate whether sham feeding alters clarity of the capsule endoscopy images. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Robert Enns, M.D. | University of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GI Clinic, St. Paul's Hospital | Vancouver | British Columbia | V6Z 1Y6 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24119509 | Background | 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. | |
| 18356113 | Background |
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 17, 2018 | |
| Reset | Mar 29, 2019 | |
| Release | Nov 10, 2020 | |
| Reset | Dec 2, 2020 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 17, 2018 | Mar 29, 2019 | |||
| Nov 10, 2020 |
Not provided
Not provided
Not provided
Not provided
| Placebo | Other | Participants will not be asked to chew bacon bits |
|
|
| 5 hours |
| Completion examination rate | To investigate whether sham feeding using bacon increases the completion examination rate (CER) | 8 hours |
| 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. |
| 18155426 | Background | 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. |
| 16181299 | Background | 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. |
| 15654777 | Background | 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. |
| 16279893 | Background | 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. |
| 16427932 | Background | 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. |
| 19152909 | Background | 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. |
| 16246685 | Background | 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. |
| 18691709 | Background | 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. |
| 18620344 | Background | 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. |
| 18556803 | Background | 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. |
| 23790243 | Background | 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. |
| 18045735 | Background | 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. |
| 7336138 | Background | 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. |
| 2702882 | Background | Stern RM, Crawford HE, Stewart WR, Vasey MW, Koch KL. Sham feeding. Cephalic-vagal influences on gastric myoelectric activity. Dig Dis Sci. 1989 Apr;34(4):521-7. doi: 10.1007/BF01536327. |
| 1634057 | Background | Katschinski M, Dahmen G, Reinshagen M, Beglinger C, Koop H, Nustede R, Adler G. Cephalic stimulation of gastrointestinal secretory and motor responses in humans. Gastroenterology. 1992 Aug;103(2):383-91. doi: 10.1016/0016-5085(92)90825-j. |
| 1854946 | Background | Brin VB, Tsabolova ZT. [The effect of calcitonin on the mechanisms of urine formation and sodium excretion in normotensive and spontaneously hypertensive rats]. Biull Eksp Biol Med. 1991 Feb;111(2):118-20. Russian. |
| 24112594 | Background | Ou G, Svarta S, Chan C, Galorport C, Qian H, Enns R. The effect of chewing gum on small-bowel transit time in capsule endoscopy: a prospective, randomized trial. Gastrointest Endosc. 2014 Apr;79(4):630-6. doi: 10.1016/j.gie.2013.08.038. Epub 2013 Oct 7. |
| 3940915 | Background | Feldman M, Richardson CT. Role of thought, sight, smell, and taste of food in the cephalic phase of gastric acid secretion in humans. Gastroenterology. 1986 Feb;90(2):428-33. doi: 10.1016/0016-5085(86)90943-1. |
| 9062523 | Background | Abdallah L, Chabert M, Louis-Sylvestre J. Cephalic phase responses to sweet taste. Am J Clin Nutr. 1997 Mar;65(3):737-43. doi: 10.1093/ajcn/65.3.737. |
| 16093874 | Background | Wicks D, Wright J, Rayment P, Spiller R. Impact of bitter taste on gastric motility. Eur J Gastroenterol Hepatol. 2005 Sep;17(9):961-5. doi: 10.1097/00042737-200509000-00012. |
| 7372066 | Background | Schiller LR, Feldman M, Richardson CT. Effect of sham feeding on gastric emptying. Gastroenterology. 1980 Jun;78(6):1472-5. |
| 1618049 | Background | Soffer EE, Adrian TE. Effect of meal composition and sham feeding on duodenojejunal motility in humans. Dig Dis Sci. 1992 Jul;37(7):1009-14. doi: 10.1007/BF01300279. |
| 3933326 | Background | Powley TL, Berthoud HR. Diet and cephalic phase insulin responses. Am J Clin Nutr. 1985 Nov;42(5 Suppl):991-1002. doi: 10.1093/ajcn/42.5.991. |
| 7652029 | Background | Teff KL, Devine J, Engelman K. Sweet taste: effect on cephalic phase insulin release in men. Physiol Behav. 1995 Jun;57(6):1089-95. doi: 10.1016/0031-9384(94)00373-d. |
| 16189787 | Background | de Franchis R, Avgerinos A, Barkin J, Cave D, Filoche B; ICCE. ICCE consensus for bowel preparation and prokinetics. Endoscopy. 2005 Oct;37(10):1040-5. doi: 10.1055/s-2005-870327. No abstract available. |
| Dec 2, 2020 |