A Study to Investigate the Effect of a Meal At 6pm the Day Before the Colonoscopy on the Bowel Cleansing with Plenvu (DinNER1006)

To Dine or Not to Dine: Effect of Day-before Light Dinner on Bowel Cleansing Prior to Colonoscopy

Bowel cleansing prior to colonoscopy is crucial to be able to perform a high-quality examination. Therefore maximum efforts are made to achieve optimal bowel cleansing including diet restriction and refraining from day-before dinner. However, the effect of this interdiction is currently not clear. On the other hand, patient compliance and experience with the entire procedure is important, especially for follow-up colonoscopies. Strict diets may interfere with this as an additional burden on the patient. In this study we want to assess whether a more lenient diet influences the quality of bowel preparation and whether it improves patient's experience.

Study Overview

• Status: Active, not recruiting
• Conditions: Healthy; Bowel Preparation; Bowel Preparation for Colonoscopy; Bowel Cleansing for Colonoscopy
• Intervention / Treatment: Behavioral: Lenient diet

• Study Type: Interventional
• Enrollment (Actual): 525
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • UZ Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Patient referred for diagnostic colonoscopy
• Age between 40 and 85 years old
• Ability of normal oral ingestion
• Able to give informed consent by the patient or the legal representative

Exclusion Criteria:

• Participant has a history of (partial) colectomy, excluding appendectomy
• Inability of oral ingestion
• Chronic severe constipation, defined as the need for daily laxative use of any kind or the need to use laxatives to obtain defaecation.
• Uncontrolled coagulopathy
• Pregnancy
• Premenopausal women not adhering to any contraceptive method
• Inflammatory bowel disease
• Lynch syndrome
• Familial adenomatosis polyposis syndrome
• Serrated polyposis syndrome
• hypersensitivity to the active substances of PLENVU as listed in the SmPC section 6.1
• gastrointestinal obstruction or perforation
• ileus
• gastric emptying disorders (e.g. gastroparesis, gastric retention, etc.)
• phenylketonuria (due to the presence of aspartame in PLENVU)
• glucose-6-phosphate dehydrogenase deficiency (due to the presence of ascorbate in PLENVU)
• toxic megacolon
• Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol
• Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lenient diet; This group can have a less stringent diet compared to the current standard of care and eat a light meal until 18h before drinking the first dose of the bowel preparation on the day before the colonoscopy	Behavioral: Lenient diet; The interventional goup receives the lenient diet instructions and will eat a light meal until 18h on the day before the colonoscopy. The first dose of Plenvu will be started at 20h. All the other bowel preparation instructions will be the same as in the control group.
No Intervention: Control group; This group follows the strict diet similar to what is currently used in standard of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of patients with an adequate bowel preparation (BBPS ≥6, and no segmental subscore ≤1)	Max 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with an optimal bowel preparation (BBPS 8-9)		Max 12 weeks
Detection rates	Adenoma Detection Rate (ADR), Polyp Detection Rate (PDR), Serrated Polyp Detection Rate (SPDR), Advanced Adenoma Detection Rate (aADR)	Max 12 weeks
Number of patients with high-quality right sided colon preparation (subscore = 3)		Max 12 weeks
Overall patient's tolerance, adherence and satisfaction based on the patient's diary		Max 12 weeks

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Collaborators: Norgine BV

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2023
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: October 18, 2024
• First Submitted That Met QC Criteria: October 18, 2024
• First Posted (Actual): October 21, 2024

Study Record Updates

• Last Update Posted (Actual): October 21, 2024
• Last Update Submitted That Met QC Criteria: October 18, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: bowel preparation; bowel cleansing; colonoscopy preparation
• Other Study ID Numbers: S66191

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No