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

Colonoscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06436833
• Other study ID #: 67017
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 24, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: Rajavithi Hospital
• Contact: Apichet Sirinawasatien, M.D.
• Phone: 023548108
• Email: sui_apichet[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 360
• Est. completion date: December 31, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Colonoscopy

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rajavithi Hospital

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison efficacy of bowel preparation before colonoscopy between 2 group	Bowel preaparation measure by Boston bowel preparation scale	During colonoscopy procedure
Secondary	Overall procedural time of colonoscopy	Duration since start colonoscopy insertion until withdrawal endoscope	During colonoscopy procedure
Secondary	Cecal intubation rate	Perform successful endoscopy to cecum	During colonoscopy procedure
Secondary	Withdrawal time of colonoscopy	Duration since endoscopy withdrawal from cecum to anal canal	During colonoscopy procedure
Secondary	Adenoma detection rate	At least one adenoma presented in this colonoscopy	During colonoscopy procedure
Secondary	Patient satisfaction in their bowel preparation regimen	Satisfaction score evaluate by Linkert scale	1 day before colonoscopy
Secondary	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