Assessment of Safety, Quality, and Acceptance of a Bowel Preparation Using a Food Kit With Laxatives

Summary

The main purpose of this research study is to learn if an alternative bowel preparation (bowel prep) for colonoscopy is safe, tolerable and effective as compared to the standard bowel prep. Participants are randomly assigned to receive one of the following bowel cleansing regimens for colonoscopy. * Standard Bowel Prep which includes a clear liquid diet the day before the scheduled procedure and two doses of a laxative, polyethylene glycol 3350 (PEG-3350) taken with 4 liters of water. * Happy Colon Foods Bowel Prep which begins the day before the scheduled procedure and contains various low residue foods (foods that are easily digested and absorbed), and seven doses of laxatives including PEG-3350 taken with a total of about 4 liters of water, senna tablets, and one dose of magnesium citrate.

Timeline

Start

2022-11-01

Primary completion

2025-06-24

Completion

2025-06-24

Publications

• Background Lahti H, Lyyra N, Hietajarvi L, Villberg J, Paakkari L. Profiles of Internet Use and Health in Adolescence: A Person-Oriented Approach. Int J Environ Res Public Health. 2021 Jun 29;18(13):6972. doi: 10.3390/ijerph18136972.
• Background Gimeno-Garcia AZ, Baute JL, Hernandez G, Morales D, Gonzalez-Perez CD, Nicolas-Perez D, Alarcon-Fernandez O, Jimenez A, Hernandez-Guerra M, Romero R, Alonso I, Gonzalez Y, Adrian Z, Carrillo M, Ramos L, Quintero E. Risk factors for inadequate bowel preparation: a validated predictive score. Endoscopy. 2017 Jun;49(6):536-543. doi: 10.1055/s-0043-101683. Epub 2017 Mar 10.
• Background Tyson SF, Burton L, McGovern A. The impact of a toolkit on use of standardised measurement tools in stroke rehabilitation. Clin Rehabil. 2015 Sep;29(9):926-34. doi: 10.1177/0269215514562590. Epub 2014 Dec 11.
• Background Hafeez M, Yuan C, Shahzad K, Aziz B, Iqbal K, Raza S. An empirical evaluation of financial development-carbon footprint nexus in One Belt and Road region. Environ Sci Pollut Res Int. 2019 Aug;26(24):25026-25036. doi: 10.1007/s11356-019-05757-z. Epub 2019 Jun 27.
• Background Othman F, Crooks CJ, Card TR. The risk of Clostridium difficile infection in patients with pernicious anaemia: a retrospective cohort study using primary care database. United European Gastroenterol J. 2017 Nov;5(7):959-966. doi: 10.1177/2050640617695697. Epub 2017 Feb 21.
• Background Chak A, Cooper GS, Canto MI, Pollack BJ, Sivak MV Jr. Enteroscopy for the initial evaluation of iron deficiency. Gastrointest Endosc. 1998 Feb;47(2):144-8. doi: 10.1016/s0016-5107(98)70347-5.
• Background Vetter B, Gasch B, Padosch SA. [Coping with complex medical emergency situations : Competent and successful decision-making, communication and leadership]. Anaesthesist. 2015 Apr;64(4):298-303. doi: 10.1007/s00101-015-2423-2. German.
• Background Smith MM, Hayes AJ, Melrose J. Pentosan Polysulfate, a Semisynthetic Heparinoid Disease-Modifying Osteoarthritic Drug with Roles in Intervertebral Disc Repair Biology Emulating the Stem Cell Instructive and Tissue Reparative Properties of Heparan Sulfate. Stem Cells Dev. 2022 Aug;31(15-16):406-430. doi: 10.1089/scd.2022.0007. Epub 2022 Mar 14.
• Background Hu S, Gong T, Ma J, Tao Y, Xian Q. Simultaneous determination of iodinated haloacetic acids and aromatic iodinated disinfection byproducts in waters with a new SPE-HPLC-MS/MS method. Chemosphere. 2018 May;198:147-153. doi: 10.1016/j.chemosphere.2018.01.124. Epub 2018 Feb 3.
• Background Rotolo F, Vitiello V, Pellegrini D, Carotenuto Y, Buttino I. Historical control data in ecotoxicology: Eight years of tests with the copepod Acartia tonsa. Environ Pollut. 2021 Sep 1;284:117468. doi: 10.1016/j.envpol.2021.117468. Epub 2021 May 27.
• Background Lai EJ, Calderwood AH, Doros G, Fix OK, Jacobson BC. The Boston bowel preparation scale: a valid and reliable instrument for colonoscopy-oriented research. Gastrointest Endosc. 2009 Mar;69(3 Pt 2):620-5. doi: 10.1016/j.gie.2008.05.057. Epub 2009 Jan 10.
• Background Raulf-Heimsoth M, Rihs HP, Rozynek P, Cremer R, Gaspar A, Pires G, Yeang HY, Arif SA, Hamilton RG, Sander I, Lundberg M, Bruning T. Quantitative analysis of immunoglobulin E reactivity profiles in patients allergic or sensitized to natural rubber latex (Hevea brasiliensis). Clin Exp Allergy. 2007 Nov;37(11):1657-67. doi: 10.1111/j.1365-2222.2007.02833.x. Epub 2007 Sep 19.
• Background Robertson GS, Ristic CD, Bullen BR. The incidence of congenitally absent foot pulses. Ann R Coll Surg Engl. 1990 Mar;72(2):99-100.
• Background Kahl S, Zimmermann S, Genz I, Glasbrenner B, Pross M, Schulz HU, Mc Namara D, Schmidt U, Malfertheiner P. Risk factors for failure of endoscopic stenting of biliary strictures in chronic pancreatitis: a prospective follow-up study. Am J Gastroenterol. 2003 Nov;98(11):2448-53. doi: 10.1111/j.1572-0241.2003.08667.x.
• Background Parsons TM, Satchithananda K, Berbe R, Siddiqui IA, Robinson E, Hart AJ. [MRI investigations in patients with problems due to metal-on-metal implants]. Orthopade. 2013 Aug;42(8):629-36. doi: 10.1007/s00132-012-2036-2. German.
• Background Riemann JF. Colorectal cancer screening in Europe: compliance and the choice of test. Endoscopy. 2010 Jul;42(7):576-7. doi: 10.1055/s-0030-1255542. Epub 2010 Jun 30. No abstract available.
• Background Klein EY. Antimalarial drug resistance: a review of the biology and strategies to delay emergence and spread. Int J Antimicrob Agents. 2013 Apr;41(4):311-7. doi: 10.1016/j.ijantimicag.2012.12.007. Epub 2013 Feb 8.
• Background Chave SP. The Duncan memorial lecture. 'Duncan of Liverpool--and some lessons for today'. Community Med. 1984 Feb;6(1):61-71. No abstract available.
• Background Scaglione G, Pietrini L, Russo F, Franco MR, Sorrentini I. Long-acting octreotide as rescue therapy in chronic bleeding from gastrointestinal angiodysplasia. Aliment Pharmacol Ther. 2007 Sep 15;26(6):935-42. doi: 10.1111/j.1365-2036.2007.03435.x.
• Background See CC, Newman LJ, Berezin S, Glassman MS, Medow MS, Dozor AJ, Schwarz SM. Gastroesophageal reflux-induced hypoxemia in infants with apparent life-threatening event(s). Am J Dis Child. 1989 Aug;143(8):951-4.
• Background Kluge MA, Williams JL, Wu CK, Jacobson BC, Schroy PC 3rd, Lieberman DA, Calderwood AH. Inadequate Boston Bowel Preparation Scale scores predict the risk of missed neoplasia on the next colonoscopy. Gastrointest Endosc. 2018 Mar;87(3):744-751. doi: 10.1016/j.gie.2017.06.012. Epub 2017 Jun 23.
• Background Lebwohl B, Kastrinos F, Glick M, Rosenbaum AJ, Wang T, Neugut AI. The impact of suboptimal bowel preparation on adenoma miss rates and the factors associated with early repeat colonoscopy. Gastrointest Endosc. 2011 Jun;73(6):1207-14. doi: 10.1016/j.gie.2011.01.051. Epub 2011 Apr 8.
• Background Rex DK, Boland CR, Dominitz JA, Giardiello FM, Johnson DA, Kaltenbach T, Levin TR, Lieberman D, Robertson DJ. Colorectal Cancer Screening: Recommendations for Physicians and Patients from the U.S. Multi-Society Task Force on Colorectal Cancer. Am J Gastroenterol. 2017 Jul;112(7):1016-1030. doi: 10.1038/ajg.2017.174. Epub 2017 Jun 6.

Drugs

Indications