Chromocolonoscopy With Food-grade Dyes

Chromoendoscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02631798
• Other study ID #: Microcapsule Chromo-122015
• Status: Recruiting
• Phase: N/A
• Start date: December 2015
• Est. completion date: July 2023

Study information

• Verified date: June 2022
• Source: University Hospital Schleswig-Holstein
• Contact: Mark Ellrichmann, MD
• Phone: 00494315972075
• Email: mark.ellrichmann[@]uksh.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Chromoendoscopy

Intervention

Dietary Supplement:
• Food grade dye mucosal staining
mucosal staining with food grade dye

Locations

Country	Name	City	State
Germany	University Hospital Schleswig-Holstein, Campus Kiel	Kiel	Schleswig-Holstein

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Schleswig-Holstein

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of mucosal staining	Assessment of mucosal staining by questionnaire	Day of scheduled endoscopy
Secondary	Number of patients with treatment related adverse events		Day of scheduled endoscopy and within 3 days after colonoscopy
Secondary	Number of patients with detected adenomas		Day of scheduled endoscopy