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

Rajavithi Hospital

Status: Enrolling

Conditions: Bowel Preparation Solution; Colonoscopy

Treatments: Drug: 2-Liter polyethylene glycol plus elobixibat; Drug: 4-Liter polyethylene glycol

Study type: Interventional

Funder types: Other

Identifiers

NCT06436833

67017

Details and patient eligibility

About

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

Full 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

Enrollment: 360 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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360 participants in 2 patient groups

2-Liter polyethylene glycol plus elobixibat

Experimental group

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.

Treatment:

Drug: 2-Liter polyethylene glycol plus elobixibat

4-Liter polyethylene glycol

Active Comparator group

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.

Treatment:

Drug: 4-Liter polyethylene glycol