Chromocolonoscopy With Food-grade Dyes

Study Overview
=================
Brief 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

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

Conditions
-----------------
Chromoendoscopy

Intervention / Treatment
-----------------
* Dietary Supplement: Food grade dye mucosal staining


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dye staining<br>Food grade dye mucosal staining | Dietary Supplement: Food grade dye mucosal staining<br>* mucosal staining with food grade dye<br>|

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 | Measure Description | 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 |