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

NCT06436833 | Recruiting DMC

• 1 other identifier: 67017
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Bowel Preparation Solution; Colonoscopy

Outcome Measures

Primary Outcomes (1)

• Comparison efficacy of bowel preparation before colonoscopy between 2 group

  Bowel preaparation measure by Boston bowel preparation scale

  During colonoscopy procedure

Secondary Outcomes (6)

• Overall procedural time of colonoscopy

  During colonoscopy procedure

• Cecal intubation rate

  During colonoscopy procedure

• Withdrawal time of colonoscopy

  During colonoscopy procedure

• Adenoma detection rate

  During colonoscopy procedure

• Patient satisfaction in their bowel preparation regimen

  1 day before colonoscopy

Study Arms (2)

2-Liter polyethylene glycol plus elobixibat

EXPERIMENTAL

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

4-Liter polyethylene glycol

ACTIVE COMPARATOR

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

Interventions

2-Liter polyethylene glycol plus elobixibat DRUG

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.

2-Liter polyethylene glycol plus elobixibat

4-Liter polyethylene glycol DRUG

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.

4-Liter polyethylene glycol

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adute aged 18-80 year old
• Indication for colonoscopy(one selected)
• Colorectal cancer screening
• Stool occult blood test positive
• History of colonic polyp
• abdominal pain
• Iron deficiency anemia
• Chronic diarrhea
• chronic constipation
• Unintentional weight loss
• Gastrointestinal bleeding
• Abnormal imagind study
• Participant acceptconsent information

You may not qualify if:

• 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

Sponsors & Collaborators

• Department of Medical Services Ministry of Public Health of Thailand: lead

Study Sites (1)

Rajavithi Hospital

Bangkok, Thailand

RECRUITING

Related Publications (9)

• 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.

  PMID: 33971037 BACKGROUND

• 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.

  PMID: 28840422 BACKGROUND

• 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.

  PMID: 27446836 BACKGROUND

• 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.

  PMID: 20883845 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.

  PMID: 19136102 BACKGROUND

• 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.

  PMID: 26232311 BACKGROUND

• 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.

  PMID: 25057297 BACKGROUND

• 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.

  PMID: 30793431 BACKGROUND

• 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.

  PMID: 12135020 BACKGROUND

MeSH Terms

Interventions

elobixibat

Study Officials

• Apichet Sirinawasatien, M.D.

  Department of Medical Services Ministry of Public Health of Thailand

  STUDY CHAIR

Central Study Contacts

Apichet Sirinawasatien, M.D.

CONTACT

023548108; sui_apichet@hotmail.com

Somchai Uthiwamek, M.D.

CONTACT

0851267424; p3n_p1ng@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2024
• First Posted: May 31, 2024
• Study Start: May 24, 2024
• Primary Completion: November 30, 2024
• Study Completion: December 31, 2024
• Last Updated: December 27, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)