Efficacy of elobixibat as bowel preparation agent for colonoscopy: Prospective, randomized, multi-center study.
Daisuke Yamaguchi, Hidenori Hidaka, Takuya Matsunaga...
https://pubmed.ncbi.nlm.nih.gov/33971037Actively Recruiting
Phase Not Applicable
Age: 18Years - 80Years
All Genders
Healthy Volunteers
ID06436833
Comparison of 2-Liter Polyethylene Glycol Plus Elobixibat Versus 4-Liter Polyethylene Glycol Bowel Preparation for Colonoscopy: A Randomized Controlled Trial
Led by Department of Medical Services Ministry of Public Health of Thailand · Updated on 2024-12-27
360
Participants Needed
1
Research Sites
31 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating two different bowel preparation regimens for patients undergoing colonoscopy at Rajavithi Hospital. The study aims to compare the effectiveness of a 2-liter polyethylene glycol (PEG) regimen combined with elobixibat versus a standard 4-liter PEG regimen. The cleanliness of the bowel preparation is assessed using the Boston bowel preparation scale to determine if there is a significant difference between the two methods. Participants are randomly assigned to one of two groups. Group 1 receives elobixibat 10 mg at 8 a.m. one day before colonoscopy, followed by 1 liter of PEG at 8 p.m. the same day and another 1 liter at 5 a.m. on the day of the colonoscopy. Group 2 receives 2 liters of PEG at 8 p.m. one day before the colonoscopy and another 2 liters at 5 a.m. on the day of the procedure. This design allows comparison of the two bowel cleansing regimens in a controlled setting. During their participation, patients undergo assessment during the colonoscopy procedure, focusing on the quality of bowel cleanliness. The Boston bowel preparation scale is used as the primary outcome measure. The study includes adults aged 18 to 80 years with indications for colonoscopy such as colorectal cancer screening or gastrointestinal symptoms. Safety and adherence are monitored throughout the study period to evaluate the preparation's effectiveness and tolerability.
CONDITIONS
Official Title
Comparison of Bowel Preparation Using 2 Liter Polyethylene Glycol Regimen Plus Elobixibat Versus 4-Liter Polyethylene Glycol Regimen
Who Can Participate
Age: 18Years - 80Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 80 years
- Indication for colonoscopy including 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, or abnormal imaging study
- Participant agrees to provide informed consent
You will not qualify if you...
- Pregnancy or lactation
- Gastroparesis or gastric outlet obstruction
- Bowel obstruction
- History of gastrointestinal tract surgery
- Inflammatory bowel disease
- ASA physical status 4 or higher
- Allergy to elobixibat or polyethylene glycol
- Chronic kidney disease stage 4 or 5 (GFR below 30 ml/min)
- Biliary tract obstruction
- Previous inadequate bowel preparation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Trial Site Locations
Total: 1 location
1
Rajavithi Hospital
Bangkok, Thailand
Actively Recruiting
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Research Team
A
Apichet Sirinawasatien, M.D.
S
Somchai Uthiwamek, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
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.
Atsushi Nakajima, Mitsunori Seki, Shinya Taniguchi
https://pubmed.ncbi.nlm.nih.gov/28840422Split-Dose Polyethylene Glycol Is Superior to Single Dose for Colonoscopy Preparation: Results of a Randomized Controlled Trial.
Rachid Mohamed, Robert J Hilsden, Catherine Dube...
https://pubmed.ncbi.nlm.nih.gov/27446836Comprehensive validation of the Boston Bowel Preparation Scale.
Audrey H Calderwood, Brian C Jacobson
https://pubmed.ncbi.nlm.nih.gov/20883845The Boston bowel preparation scale: a valid and reliable instrument for colonoscopy-oriented research.
Edwin J Lai, Audrey H Calderwood, Gheorghe Doros...
https://pubmed.ncbi.nlm.nih.gov/191361022-Litre polyethylene glycol-citrate-simethicone plus bisacodyl versus 4-litre polyethylene glycol as preparation for colonoscopy in chronic constipation.
Fabrizio Parente, Cristian Vailati, Stefano Bargiggia...
https://pubmed.ncbi.nlm.nih.gov/26232311Elobixibat and its potential role in chronic idiopathic constipation.
Andres Acosta, Michael Camilleri
https://pubmed.ncbi.nlm.nih.gov/25057297Efficacy, 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.
Atsushi Nakajima, Shinya Taniguchi, Shinsuke Kurosu...
https://pubmed.ncbi.nlm.nih.gov/30793431Impact of bowel preparation on efficiency and cost of colonoscopy.
Douglas K Rex, Thomas F Imperiale, Danielle R Latinovich...
https://pubmed.ncbi.nlm.nih.gov/12135020