RecruitingNot ApplicableNCT06436833

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

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


Sponsor

Department of Medical Services Ministry of Public Health of Thailand

Enrollment

360 participants

Start Date

May 24, 2024

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria13

  • 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

Exclusion Criteria10

  • 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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Interventions

DRUG2-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.

DRUG4-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(1)

Rajavithi Hospital

Bangkok, Thailand

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NCT06436833


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