Comparison of Bowel Preparation Using 2 Liter Polyethylene Glycol Regimen Plus Elobixibat Versus 4-Liter Polyethylene Glycol Regimen

Comparison of Bowel Preparation Using 2 Liter Polyethylene Glycol Regimen Plus Elobixibat Versus 4-Liter Polyethylene Glycol Regimen: a Randomized Controlled Trial

Comparison of bowel preparation using 2 liter polyethylene glycol regimen plus elobixibat Versus 4-Liter polyethylene glycol regimen. This study based on hypothesis that show Boston bowel preparation scale which 2L PEG regimen plus Elobixibat have result no significant difference from 4L PEG regimen

Study Overview

• Status: Recruiting
• Conditions: Colonoscopy; Bowel Preparation Solution
• Intervention / Treatment: Drug: 2-Liter polyethylene glycol plus elobixibat; Drug: 4-Liter polyethylene glycol

Detailed Description

The trial study in participant who visit to Rajavithi hospital for indication of colonoscopy such as Colorectal cancer screening, Iron deficiency anemia, Chronic diarrhea, chronic constipation, abdominal pain, unintentional weight loss, History of stool occult blood test , abnormal finding from imaging

Randomized participant as above in to two group as bowel preparation regimen Group 1 the participant recieved Polyethylene glycol 2 liter split dose plus Elobixibat 10 milligram.

Group 2 the participant recieved Polyethylene 4 liter split dose

Result of the study show the difference of 2 regimen of bowel preparation which regimen better than another by measuring cleanliness of bowel preparation. The cleanliness of bowel preparation measured by Boston bowel preparation scale

• Study Type: Interventional
• Enrollment (Estimated): 360
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Apichet Sirinawasatien, M.D.; Phone Number: 023548108; Email: sui_apichet@hotmail.com
• Study Contact Backup: Name: Somchai Uthiwamek, M.D.; Phone Number: 0851267424; Email: p3n_p1ng@hotmail.com

Study Locations

• Thailand
  • Bangkok, Thailand
    • Recruiting
    • Rajavithi Hospital
    • Contact: Rajavithi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Adute aged 18-80 year old

• Indication for colonoscopy(one selected)

  1. Colorectal cancer screening
  2. Stool occult blood test positive
  3. History of colonic polyp
  4. abdominal pain
  5. Iron deficiency anemia
  6. Chronic diarrhea
  7. chronic constipation
  8. Unintentional weight loss
  9. Gastrointestinal bleeding
  10. Abnormal imagind study
• Participant acceptconsent information

Exclusion Criteria:

• Pregnancy or lactation
• Gastroparesis, gastric outlet obstuction
• Bowel obstruction
• Gastrointestinal tract surgery
• Inflammatory bowel disease
• ASA(American society of anesthesiologist physical status) status > or = 4
• Allergic to Elobixibat or PEG
• Chronic kidney disease stage 4-5(GFR <30 ml/min)
• Biliary tract obstruction
• Previous history of inadequate bowel preparation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 2-Liter polyethylene glycol plus elobixibat; Take Elobixibat 10 mg, one day before colonoscopy at 8 a.m. Take Polyethylene glycol 1 Liter, one day before colonoscopy at 8 p.m. Take polyethylene glycol 1 Liter, at day of colonoscopy at 5 a.m.	Drug: 2-Liter polyethylene glycol plus elobixibat; Take Elobixibat 10 mg, one day before colonoscopy at 8 a.m. Take Polyethylene glycol 1 Liter, one day before colonoscopy at 8 p.m. Take polyethylene glycol 1 Liter, at day of colonoscopy at 5 a.m.
Active Comparator: 4-Liter polyethylene glycol; Take Polyethylene glycol 2 Liter, one day before colonoscopy at 8 p.m. Take polyethylene glycol 2 Liter, at day of colonoscopy at 5 a.m.	Drug: 4-Liter polyethylene glycol; Take Polyethylene glycol 2 Liter, one day before colonoscopy at 8 p.m. Take polyethylene glycol 2 Liter, at day of colonoscopy at 5 a.m.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison efficacy of bowel preparation before colonoscopy between 2 group	Bowel preaparation measure by Boston bowel preparation scale	During colonoscopy procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall procedural time of colonoscopy	Duration since start colonoscopy insertion until withdrawal endoscope	During colonoscopy procedure
Cecal intubation rate	Perform successful endoscopy to cecum	During colonoscopy procedure
Withdrawal time of colonoscopy	Duration since endoscopy withdrawal from cecum to anal canal	During colonoscopy procedure
Adenoma detection rate	At least one adenoma presented in this colonoscopy	During colonoscopy procedure
Patient satisfaction in their bowel preparation regimen	Satisfaction score evaluate by Linkert scale	1 day before colonoscopy
Adverse event in each group	Nausea, vomiting, abdominal pain, bloating, sleep disturbance, chest pain, dizziness, dyspnea, leg edema	During 24 hour after taking bowel preparation

Collaborators and Investigators

• Sponsor: Rajavithi Hospital
• Investigators: Study Chair: Apichet Sirinawasatien, M.D., Rajavithi Hospital

Publications and helpful links

General Publications

• 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.
• Calderwood AH, Jacobson BC. Comprehensive validation of the Boston Bowel Preparation Scale. Gastrointest Endosc. 2010 Oct;72(4):686-92. doi: 10.1016/j.gie.2010.06.068.
• Rex DK, Imperiale TF, Latinovich DR, Bratcher LL. Impact of bowel preparation on efficiency and cost of colonoscopy. Am J Gastroenterol. 2002 Jul;97(7):1696-700. doi: 10.1111/j.1572-0241.2002.05827.x.
• Parente F, Vailati C, Bargiggia S, Manes G, Fontana P, Masci E, Arena M, Spinzi G, Baccarin A, Mazzoleni G, Testoni PA. 2-Litre polyethylene glycol-citrate-simethicone plus bisacodyl versus 4-litre polyethylene glycol as preparation for colonoscopy in chronic constipation. Dig Liver Dis. 2015 Oct;47(10):857-63. doi: 10.1016/j.dld.2015.06.008. Epub 2015 Jul 6.
• Yamaguchi D, Hidaka H, Matsunaga T, Akutagawa T, Tanaka Y, Jubashi A, Takeuchi Y, Tsuruoka N, Sakata Y, Miyahara K, Tominaga N, Kawakubo H, Takamori A, Shimoda R, Noda T, Ogata S, Tsunada S, Esaki M. Efficacy of elobixibat as bowel preparation agent for colonoscopy: Prospective, randomized, multi-center study. Dig Endosc. 2022 Jan;34(1):171-179. doi: 10.1111/den.14010. Epub 2021 May 24.
• Nakajima A, Seki M, Taniguchi S. Determining an optimal clinical dose of elobixibat, a novel inhibitor of the ileal bile acid transporter, in Japanese patients with chronic constipation: a phase II, multicenter, double-blind, placebo-controlled randomized clinical trial. J Gastroenterol. 2018 Apr;53(4):525-534. doi: 10.1007/s00535-017-1383-5. Epub 2017 Aug 24.
• Mohamed R, Hilsden RJ, Dube C, Rostom A. Split-Dose Polyethylene Glycol Is Superior to Single Dose for Colonoscopy Preparation: Results of a Randomized Controlled Trial. Can J Gastroenterol Hepatol. 2016;2016:3181459. doi: 10.1155/2016/3181459. Epub 2016 Apr 13.
• Acosta A, Camilleri M. Elobixibat and its potential role in chronic idiopathic constipation. Therap Adv Gastroenterol. 2014 Jul;7(4):167-75. doi: 10.1177/1756283X14528269.
• Nakajima A, Taniguchi S, Kurosu S, Gillberg PG, Mattsson JP, Camilleri M. Efficacy, long-term safety, and impact on quality of life of elobixibat in more severe constipation: Post hoc analyses of two phase 3 trials in Japan. Neurogastroenterol Motil. 2019 May;31(5):e13571. doi: 10.1111/nmo.13571. Epub 2019 Feb 21.

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2024
• Primary Completion (Actual): November 30, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: May 24, 2024
• First Submitted That Met QC Criteria: May 24, 2024
• First Posted (Actual): May 31, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 20, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 67017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan for IPD sharing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No