Bowel Preparation Regimen for Colon Capsule Endoscopy Procedure

NCT05726097 | Completed Phase 3

• 1 other identifier: 2022-06303-02
• Study Type: interventional
• Target: 147
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colon Cancer; Inflammatory Bowel Diseases; Gastrointestinal Bleed; Colon Polyp

Keywords

colon capsule endoscopy; panenteric capsule endoscopy; colon preparation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Transit times

  Within 3 months after completed capsule colonoscopy

• Diagnostic yield

  Within 3 months after completed capsule colonoscopy

• Assessment of patient tolerance of the bowel preparations

  Within 3 months after completed capsule colonoscopy

Study Arms (3)

Standard preparation regimen

ACTIVE COMPARATOR

4 L polyethylene glycol as laxative 30 + 15 mL sodium phosphate as a booster

Drug: polyethylene glycol; Drug: sodium phosphate

Optimized preparation regimen

EXPERIMENTAL

1 L polyethylene glycol + ascorbic acid as laxative and gastrografin and magnesiumoxid + sodium picosulfate as a booster

Drug: polyethylene glycol + ascorbic acid; Drug: gastrografin; Drug: magnesiumoxid + sodium picosulfate

Optimized preparation regimen with prucalopride

EXPERIMENTAL

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; Drug: gastrografin; Drug: magnesiumoxid + sodium picosulfate; Drug: prucalopride

Interventions

polyethylene glycol DRUG

colonic preparation

Also known as: Laxabon

Standard preparation regimen

sodium phosphate DRUG

colonic preparation

Also known as: Phosphoral

Standard preparation regimen

polyethylene glycol + ascorbic acid DRUG

colonic preparation

Also known as: Plenvu

Optimized preparation regimen; Optimized preparation regimen with prucalopride

gastrografin DRUG

colonic preparation

Optimized preparation regimen; Optimized preparation regimen with prucalopride

magnesiumoxid + sodium picosulfate DRUG

colonic preparation

Also known as: Picoprep

Optimized preparation regimen; Optimized preparation regimen with prucalopride

prucalopride DRUG

colonic preparation

Also known as: Resolol

Optimized preparation regimen with prucalopride

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Region Skane: lead
• Lund University: collaborator
• Odense University Hospital: collaborator

Study Sites (1)

Skåne University Hospital

Malmo, 20502, Sweden

Location

MeSH Terms

Conditions

Colonic Neoplasms; Inflammatory Bowel Diseases; Gastrointestinal Hemorrhage; Colonic Polyps

Interventions

Polyethylene Glycols; sodium phosphate; Ascorbic Acid; Diatrizoate Meglumine; picosulfate sodium; prucalopride

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Gastroenteritis; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intestinal Polyps; Polyps; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Hydroxy Acids; Carbohydrates; Meglumine; Sorbitol; Sugar Alcohols; Diatrizoate; Triiodobenzoic Acids; Iodobenzoates; Benzoates; Acids, Carbocyclic; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Hexosamines; Amino Sugars

Study Officials

• Ervin Toth, MD PhD

  Department of Gastroenterology, Skåne University Hospital, Malmö, Lund University, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2022
• First Posted: February 13, 2023
• Study Start: February 1, 2023
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)