Chromocolonoscopy With Food-grade Dyes

NCT02631798 | Unknown

• 1 other identifier: Microcapsule Chromo-122015
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Chromoendoscopy

Outcome Measures

Primary Outcomes (1)

• Quality of mucosal staining

  Assessment of mucosal staining by questionnaire

  Day of scheduled endoscopy

Secondary Outcomes (2)

• 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

Study Arms (1)

Dye staining

EXPERIMENTAL

Food grade dye mucosal staining

Dietary Supplement: Food grade dye mucosal staining

Interventions

Food grade dye mucosal staining DIETARY_SUPPLEMENT

mucosal staining with food grade dye

Dye staining

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Schleswig-Holstein: lead

Study Sites (1)

University Hospital Schleswig-Holstein, Campus Kiel

Kiel, Schleswig-Holstein, 24105, Germany

RECRUITING

Study Officials

• Mark Ellrichmann, MD

  University Hospital Schleswig-Holstein

  PRINCIPAL INVESTIGATOR

• Stefan Schreiber, Prof.

  University Hospital Schleswig-Holstein

  STUDY DIRECTOR

Central Study Contacts

Mark Ellrichmann, MD

CONTACT

00494315972075; mark.ellrichmann@uksh.de

Stefan Schreiber, Prof.

CONTACT

00494315971272; s.schreiber@mucosa.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Interdisciplinary Endoscopy

Study Record Dates

• First Submitted: December 4, 2015
• First Posted: December 16, 2015
• Study Start: December 1, 2015
• Primary Completion: June 1, 2023
• Study Completion: July 1, 2023
• Last Updated: July 1, 2022

Record last verified: 2022-06

Locations

DE (1)