Bowel Preparation Regimen for Colon Capsule Endoscopy Procedure

Optimization of the Bowel Preparation Regimen for Colon Capsule Endoscopy Procedure

The study aims to investigate the effect of the optimized bowel preparation and boost regimens on colon capsule endoscopy procedures, specifically on cleanliness and completion rate.

Study Overview

• Status: Completed
• Conditions: Inflammatory Bowel Diseases; Colon Cancer; Colon Polyp; Gastrointestinal Bleed
• Intervention / Treatment: Drug: polyethylene glycol; Drug: sodium phosphate; Drug: polyethylene glycol + ascorbic acid; Drug: gastrografin; Drug: magnesiumoxid + sodium picosulfate; Drug: prucalopride

Detailed Description

Colon capsule endoscopy (CCE) is a promising modality for lower gastrointestinal (GI) investigations in clinical routine and screening. Furthermore, the double-headed camera capsules are being applied for panenteric investigations, with promising results. The major limitation to its use has been finding a bowel preparation that will clean the colon adequately for good visualization of the mucosa and help propel the capsule using boosters through the colon. To achieve wider CCE adoption, challenges regarding completion rates (CR) and adequate cleanliness rates (ACR) must be handled. CR and ACR should be improved to meet the standards for optical colonoscopy (OC) from the European Society of GI Endoscopy (ESGE). ESGE recommends both CR and ACR ≥ 90%. Recently, a meta-analysis of preparation regimens for CCE confirmed that CR and ACR were suboptimal.

This study is designed to investigate the CR, ACR, and diagnostic yield (DY) of very low-volume polyethylene glycol (PEG) - based laxative compared to a conventional high-volume laxative and the use of different boosters.

All consecutive patients referred for colon capsule endoscopy will be enrolled in the study. PillCam® Crohn's capsule will be used. Patients will undergo a split-dose bowel preparation with a very low-volume PEG-based laxative. In the study arm nr1 gastrografin and magnesiumoxid + sodium picosulfate will be used. In the study arm Nr 2, the same regimen will be used but completed with 2 mg of prucalopride before ingesting the capsule. The results of the study arms will be compared to the previously used standard regimen with 4 L of PEG as a laxative and sodium phosphate as a booster.

The images from the colon capsule will be reviewed, and the quality of bowel preparation (cleanliness rates) and completion rate will be evaluated. Patient tolerance of the bowel preparations and diagnostic yield of colon capsule endoscopy using the different preparation regimens will also be evaluated.

• Study Type: Interventional
• Enrollment (Actual): 147
• Phase: Phase 3

Contacts and Locations

Study Locations

• Sweden
  • Malmö, Sweden, 20502
    • Skåne University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Subject referred for clinical colon/panenteric examination
• Subject received an explanation about the nature of the study and agreed to provide written informed consent

Exclusion Criteria:

• Subject with dysphagia or any swallowing disorder
• Subject with a prior stomach, small bowel, or colonic resection
• Subject with severe renal insufficiency
• Subject with any allergy or other known contraindication to the medications used in the study
• Women who are either pregnant or nursing
• Subject suffers from life threatening conditions

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard preparation regimen; 4 L polyethylene glycol as laxative 30 + 15 mL sodium phosphate as a booster	Drug: polyethylene glycol; colonic preparation; Other Names: Laxabon; Drug: sodium phosphate; colonic preparation; Other Names: Phosphoral
Experimental: Optimized preparation regimen; 1 L polyethylene glycol + ascorbic acid as laxative and gastrografin and magnesiumoxid + sodium picosulfate as a booster	Drug: polyethylene glycol + ascorbic acid; colonic preparation; Other Names: Plenvu; Drug: gastrografin; colonic preparation; Drug: magnesiumoxid + sodium picosulfate; colonic preparation; Other Names: Picoprep
Experimental: Optimized preparation regimen with prucalopride; 1 L polyethylene glycol + ascorbic acid as laxative and gastrografin and magnesiumoxid + sodium picosulfate as a booster + 2 mg of prucalopride	Drug: polyethylene glycol + ascorbic acid; colonic preparation; Other Names: Plenvu; Drug: gastrografin; colonic preparation; Drug: magnesiumoxid + sodium picosulfate; colonic preparation; Other Names: Picoprep; Drug: prucalopride; colonic preparation; Other Names: Resolol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Completeness rate	Visualization of the hemorrhoidal plexus or an excreted capsule	Within 3 months after completed capsule colonoscopy
Adequate cleanliness rate	Assessment of the quality of the bowel preparation using a the 4-point Leighton-Rex scale	Within 3 months after completed capsule colonoscopy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transit times	Determining the amount of time for the capsule to transit through the stomach, small bowel and large bowel for the different preparations	Within 3 months after completed capsule colonoscopy
Diagnostic yield	Findings in the small and large bowel	Within 3 months after completed capsule colonoscopy
Assessment of patient tolerance of the bowel preparations	Survey questionnaire to be completed by participants at the time of the colon capsule endoscopy assessing the tolerability of the preparation and side effects	Within 3 months after completed capsule colonoscopy

Collaborators and Investigators

• Sponsor: Region Skane
• Collaborators: Odense University Hospital; Lund University
• Investigators: Principal Investigator: Ervin Toth, MD PhD, Department of Gastroenterology, Skåne University Hospital, Malmö, Lund University, Sweden

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Actual): October 31, 2023
• Study Completion (Actual): October 31, 2023

Study Registration Dates

• First Submitted: December 22, 2022
• First Submitted That Met QC Criteria: February 9, 2023
• First Posted (Actual): February 13, 2023

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: colon preparation; colon capsule endoscopy; panenteric capsule endoscopy
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Hemorrhage; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Gastrointestinal Hemorrhage; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Protective Agents; Micronutrients; Serotonin Agents; Serotonin Receptor Agonists; Vitamins; Antioxidants; Cathartics; Laxatives; Serotonin 5-HT4 Receptor Agonists; Picosulfate sodium; Ascorbic Acid; Prucalopride
• Other Study ID Numbers: 2022-06303-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No