Comparing two bowel preparation methods for colonoscopy
Comparison of Bowel Preparation Using 2 Liter Polyethylene Glycol Regimen Plus Elobixibat Versus 4-Liter Polyethylene Glycol Regimen: a Randomized Controlled Trial
This study is testing whether a smaller dose of a bowel prep drink combined with a new medication works better than the standard larger dose to help people get ready for a colonoscopy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 360 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Department of Medical Services Ministry of Public Health of Thailand Government |
| Locations | 1 site (Bangkok) |
| Trial ID | NCT06436833 on ClinicalTrials.gov |
What this trial studies
This trial compares the effectiveness of a 2-liter polyethylene glycol (PEG) regimen combined with elobixibat against a standard 4-liter PEG regimen for bowel preparation prior to colonoscopy. Participants visiting Rajavithi Hospital for various indications, such as colorectal cancer screening and gastrointestinal symptoms, will be randomly assigned to one of the two preparation groups. The study aims to evaluate the cleanliness of bowel preparation using the Boston bowel preparation scale to determine which regimen is more effective.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 who require a colonoscopy for specific medical indications.
Not a fit: Patients with conditions such as bowel obstruction, inflammatory bowel disease, or those who are pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a more effective and less burdensome bowel preparation method for patients undergoing colonoscopy.
How similar studies have performed: Other studies have shown varying success with different bowel preparation regimens, but this specific combination of 2L PEG and elobixibat is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bangkok
- Rajavithi Hospital — Bangkok, Thailand (Recruiting)
Study contacts
- Study coordinator: Apichet Sirinawasatien, M.D.
- Email: sui_apichet@hotmail.com
- Phone: 023548108
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.