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

Not Applicable

Recruiting

• Conditions: Bowel Preparation Solution; Colonoscopy
• Interventions: Drug: 2-Liter polyethylene glycol plus elobixibat; Drug: 4-Liter polyethylene glycol

• Registration Number: NCT06436833
• Lead Sponsor: Rajavithi Hospital

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

Study Timeline

• Status Verified: 2024-05
• Study Start: 2024-05-24
• Study First Submitted: 2024-05-24
• Study First Submitted QC: 2024-05-24
• Study First Posted: 2024-05-31
• Primary Completion: 2024-11-30
• Last Update Submitted: 2024-12-20
• Last Update Posted: 2024-12-27
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 360

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2-Liter polyethylene glycol plus elobixibat	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	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.

Primary Outcome Measures

Name	Time	Method
Comparison efficacy of bowel preparation before colonoscopy between 2 group	During colonoscopy procedure	Bowel preaparation measure by Boston bowel preparation scale

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Rajavithi Hospital; 🇹🇭 Bangkok, Thailand