## Protocol Section
### Identification Module
**NCT ID:** NCT06436833

**Brief Title:** Comparison of Bowel Preparation Using 2 Liter Polyethylene Glycol Regimen Plus Elobixibat Versus 4-Liter Polyethylene Glycol Regimen

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

#### Organization Study ID Info
**ID:** 67017
#### Organization
**Class:** OTHER_GOV
**Full Name:** Rajavithi Hospital
### Status Module
#### Completion Date
**Date:** 2024-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-24

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-11-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-24

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER_GOV

**Name:** Rajavithi Hospital

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** True

### Description Module

**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

**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

### Conditions Module

**Conditions:**

- Bowel Preparation Solution

- Colonoscopy

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 360

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Drug: 2-Liter polyethylene glycol plus elobixibat

**Label:** 2-Liter polyethylene glycol plus elobixibat

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 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.

**Intervention Names:**

- Drug: 4-Liter polyethylene glycol

**Label:** 4-Liter polyethylene glycol

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 2-Liter polyethylene glycol plus elobixibat

**Description:** 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.

**Name:** 2-Liter polyethylene glycol plus elobixibat

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- 4-Liter polyethylene glycol

**Description:** 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.

**Name:** 4-Liter polyethylene glycol

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Bowel preaparation measure by Boston bowel preparation scale

**Measure:** Comparison efficacy of bowel preparation before colonoscopy between 2 group

**Time Frame:** During colonoscopy procedure

#### Secondary Outcomes

**Description:** Duration since start colonoscopy insertion until withdrawal endoscope

**Measure:** Overall procedural time of colonoscopy

**Time Frame:** During colonoscopy procedure

**Description:** Perform successful endoscopy to cecum

**Measure:** Cecal intubation rate

**Time Frame:** During colonoscopy procedure

**Description:** Duration since endoscopy withdrawal from cecum to anal canal

**Measure:** Withdrawal time of colonoscopy

**Time Frame:** During colonoscopy procedure

**Description:** At least one adenoma presented in this colonoscopy

**Measure:** Adenoma detection rate

**Time Frame:** During colonoscopy procedure

**Description:** Satisfaction score evaluate by Linkert scale

**Measure:** Patient satisfaction in their bowel preparation regimen

**Time Frame:** 1 day before colonoscopy

**Description:** Nausea, vomiting, abdominal pain, bloating, sleep disturbance, chest pain, dizziness, dyspnea, leg edema

**Measure:** Adverse event in each group

**Time Frame:** During 24 hour after taking bowel preparation

### Eligibility Module

**Eligibility Criteria:** 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

**Healthy Volunteers:** True

**Maximum Age:** 80 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** sui_apichet@hotmail.com

**Name:** Apichet Sirinawasatien, M.D.

**Phone:** 023548108

**Role:** CONTACT

**Contact 2:**

**Email:** p3n_p1ng@hotmail.com

**Name:** Somchai Uthiwamek, M.D.

**Phone:** 0851267424

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** Rajavithi Hospital

**Name:** Apichet Sirinawasatien, M.D.

**Role:** STUDY_CHAIR

### IPD Sharing Statement Module

**Description:** No plan for IPD sharing

**IPD Sharing:** NO

### References Module

#### References

**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.

**PMID:** 33971037

**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.

**PMID:** 28840422

**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.

**PMID:** 27446836

**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.

**PMID:** 20883845

**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.

**PMID:** 19136102

**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.

**PMID:** 26232311

**Citation:** 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

**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.

**PMID:** 30793431

**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.

**PMID:** 12135020

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
