Randomized Clinical Trial
Copyright ©The Author(s) 2017. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Dec 28, 2017; 23(48): 8615-8625
Published online Dec 28, 2017. doi: 10.3748/wjg.v23.i48.8615
Multicenter, randomized study to optimize bowel preparation for colon capsule endoscopy
David Kastenberg, Wilmot C Burch Jr, David P Romeo, Pankaj K Kashyap, David C Pound, Neophytos Papageorgiou, Ignacio Fernández-Urien Sainz, Carly E Sokach, Douglas K Rex
David Kastenberg, Division of Gastroenterology, Thomas Jefferson University, Philadelphia, PA 19107, United States
Wilmot C Burch Jr, Franklin Gastroenterology, PLLC, Franklin, TN 37067, United States
David P Romeo, Dayton Gastroenterology, Inc., Beavercreek, OH 45540, United States
Pankaj K Kashyap, Pinnacle Research Group LLC, Anniston, AL 36207, United States
David C Pound, Indianapolis Gastroenterology and Hepatology, Indianapolis, IN 46237, United States
Neophytos Papageorgiou, Department of Gastroenterology, American Medical Center, Nicosia 1311, Cyprus
Ignacio Fernández-Urien Sainz, Department of Gastroenterology, Servicio de Digestivo, Hospital de Navarra, Pamplona 31001, Spain
Carly E Sokach, Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, PA 19107, United States
Douglas K Rex, Indiana University Hospital, Indianapolis, IN 19107, United States
Author contributions: Rex DK contributed to conception and design of the study; Kastenberg D, Burch WC, Romeo DP, Kashyap PK, Pound DC, Papageorgiou NP, Fernández-Urien Sainz I and Rex DK acquired the data; Kastenberg D and Rex DK contributed to analysis and interpretation of the data; Kastenberg D and Sokach CE drafted the article; Kastenberg D critically revised the article for important intellectual content; all authors approved the final article.
Institutional review board statement: Each center obtained IRB approval prior to study initiation from the respective IRB or Research Ethics Committee.
Clinical trial registration statement: This study and protocol was registered with clinicaltrials.gov (ID# NCT02481219)
Informed consent statement: All study participants, or their legal guardian, provided informed written consent prior to study enrollment.
Conflict-of-interest statement: Kastenberg D, reports grants and advisory board fees from Ferring, outside the submitted work. Burch WC, Romeo PD, Kashyap PK, Pound DC, and Sokach CE, do not declare any conflict of interests. Fernández-Urien Sainz I, reports personal fees from Medtronic, during the conduct of the study; personal fees from Medtronic, outside the submitted work. Papageorgiou NP, reports personal fees from Medtronic, during the conduct of the study; personal fees from Medtronic, outside the submitted work. Rex DK, reports other from Medtronic, during the conduct of the study; other from Medtronic, outside the submitted work; and Consulting fees, Olympus hororaria; Boston Scientific Research support; Endochoice; Endo Aid, Modivators, Boston Scientific.
Data sharing statement: All of the individual participant data collected during the trial, after de-identification, is available at www.clinicaltrials.gov (NCT 02481219) and will be accessible to anyone who wishes to access the data for any purpose.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: David Kastenberg, FACP, MD, Professor, Division of Gastroenterology and Hepatology, Thomas Jefferson University, 4th Floor Main Building, 132 South 10th St. Philadelphia, PA 19107, United States. david.kastenberg@jefferson.edu
Telephone: +1-215-9558900 Fax: +1-215-9555513
Received: September 1, 2017
Peer-review started: September 3, 2017
First decision: September 13, 2017
Revised: September 29, 2017
Accepted: November 21, 2017
Article in press: November 21, 2017
Published online: December 28, 2017
Processing time: 117 Days and 8.3 Hours
Core Tip

Core tip: Current bowel preparation boost agents for colon capsule endoscopy have associated risks and contraindications. This paper describes a new boost agent comprised of two very low dose hyperosmotic agents, oral sodium sulfate and diatrizoate solution, which appears to be an acceptable alternative regimen for colon capsule endoscopy.