Clinical trial NCT06436833: Comparison of Bowel Preparation Using 2 Liter Polyethylene Glycol Regimen Plus Elobixibat Versus 4-Liter Polyethylene Glycol Regimen
Official title: Comparison of Bowel Preparation Using 2 Liter Polyethylene Glycol Regimen Plus Elobixibat Versus 4-Liter Polyethylene Glycol Regimen: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bowel Preparation Solution
Colonoscopy
Lead sponsor: Department of Medical Services Ministry of Public Health of Thailand
Sponsor class: OTHER_GOV
First posted: 2024-05-31
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility 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

Primary outcomes:
measure: Comparison efficacy of bowel preparation before colonoscopy between 2 group
timeFrame: During colonoscopy procedure
Secondary outcomes:
measure: Overall procedural time of colonoscopy
timeFrame: During colonoscopy procedure
measure: Cecal intubation rate
timeFrame: During colonoscopy procedure
measure: Withdrawal time of colonoscopy
timeFrame: During colonoscopy procedure
measure: Adenoma detection rate
timeFrame: During colonoscopy procedure
measure: Patient satisfaction in their bowel preparation regimen
timeFrame: 1 day before colonoscopy
measure: Adverse event in each group
timeFrame: During 24 hour after taking bowel preparation
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Rajavithi Hospital
Study officials:
affiliation: Department of Medical Services Ministry of Public Health of Thailand
name: Apichet Sirinawasatien, M.D.
role: STUDY_CHAIR
References:
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citation: Parente F, Vailati C, Bargiggia S, Manes G, Fontana P, Masci E, Arena M, Spinzi G, Baccarin A, Mazzoleni G, Testoni PA. 2-Litre polyethylene glycol-citrate-simethicone plus bisacodyl versus 4-litre polyethylene glycol as preparation for colonoscopy in chronic constipation. Dig Liver Dis. 2015 Oct;47(10):857-63. doi: 10.1016/j.dld.2015.06.008. Epub 2015 Jul 6.
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citation: Nakajima A, Taniguchi S, Kurosu S, Gillberg PG, Mattsson JP, Camilleri M. Efficacy, 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. Neurogastroenterol Motil. 2019 May;31(5):e13571. doi: 10.1111/nmo.13571. Epub 2019 Feb 21.
citation: Rex DK, Imperiale TF, Latinovich DR, Bratcher LL. Impact of bowel preparation on efficiency and cost of colonoscopy. Am J Gastroenterol. 2002 Jul;97(7):1696-700. doi: 10.1111/j.1572-0241.2002.05827.x.