Chromocolonoscopy With Food-grade Dyes

Mucosal Staining After Oral Administration of Food Grade Dyes in Subjects Undergoing Outpatients Colonoscopy

Previous with methylene blue suggested that oral administration may be superior to conventional spray catheters. The main advantages claimed were better staining due to longer exposure to the dye, more uniform staining due to normal position of the intestines (during conventional chromocolonoscopy, patients are lying on one side), and a quicker and more comfortable procedure for the patients and endoscopy personnel.

Using food-grade dyes would enable higher dye loads and lower systemic side effects.

Food grade dyes will be administered orally during preparation with KleanPrep (total amount of 4 liters) in patients undergoing screening colonoscopy.

On day 1 patients will drink 3 l of the preparation solution, the last liter together with the last dose of dye will be administered 5 hours before scheduled colonoscopy.

Primary endpoints:

• quality of mucosal staining of colon (assessed by questionnaire)

Secondary endpoints:

• adenoma detection rate
• adverse events
• time of colonoscopy

Study Overview

• Status: Recruiting
• Conditions: Chromoendoscopy
• Intervention / Treatment: Dietary supplement: Food grade dye mucosal staining

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mark Ellrichmann, MD; Phone Number: 00494315972075; Email: mark.ellrichmann@uksh.de
• Study Contact Backup: Name: Stefan Schreiber, Prof.; Phone Number: 00494315971272; Email: s.schreiber@mucosa.de

Study Locations

• Germany
  • Schleswig-Holstein
    • Kiel, Schleswig-Holstein, Germany, 24105
      • Recruiting
      • University Hospital Schleswig-Holstein, Campus Kiel
      • Contact: Mark Ellrichmann, MD; Phone Number: 00494315972075; Email: mark.ellrichmann@uksh.de
      • Contact: Stefan Schreiber, Prof.; Phone Number: 00494315971272; Email: s.schreiber@mucosa.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy males and post-menopausal females aged 18 to 75 y and scheduled for screening colonoscopy
• body weight ≥60 kg
• good health based on medical history, physical examination, a 12-lead electrocardiogram (ECG) and routine haematology and blood chemistry tests
• ability to understand and comply with the protocol
• written informed consent

Exclusion Criteria:

• standard criteria for bioavailability estimation of new drugs, namely (i) intake of any medication, (ii) a history of drug, caffeine (>5 cups coffee/tea/day) or tobacco (≥10 cigarettes/day) abuse, (iii) history of alcohol consumption in excess of two drinks per day in males and one drink per day in females
• known or suspected hypersensitivity to food colourants,
• GI obstruction or perforation
• serious cardiovascular, renal or hepatic disease
• prolonged prothrombin time, elevated INR (international normalized ration)
• elevated serum creatinine
• any other severe underlying medical condition

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dye staining; Food grade dye mucosal staining	Dietary supplement: Food grade dye mucosal staining; mucosal staining with food grade dye

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of mucosal staining	Assessment of mucosal staining by questionnaire	Day of scheduled endoscopy

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of patients with treatment related adverse events	Day of scheduled endoscopy and within 3 days after colonoscopy
Number of patients with detected adenomas	Day of scheduled endoscopy

Collaborators and Investigators

• Sponsor: University Hospital Schleswig-Holstein
• Investigators: Principal Investigator: Mark Ellrichmann, MD, University Hospital Schleswig-Holstein, Campus Kiel; Study Director: Stefan Schreiber, Prof., University Hospital Schleswig-Holstein, Campus Kiel

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: December 4, 2015
• First Submitted That Met QC Criteria: December 15, 2015
• First Posted (Estimate): December 16, 2015

Study Record Updates

• Last Update Posted (Actual): July 1, 2022
• Last Update Submitted That Met QC Criteria: June 30, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: Microcapsule Chromo-122015