ChromoendoscopyNCT02631798
Chromocolonoscopy With Food-grade Dyes
A study testing Food grade dye mucosal staining in people with Chromoendoscopy, run by University Hospital Schleswig-Holstein at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Chromoendoscopy
- What is being tested?
- Food grade dye mucosal staining
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2015to Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Schleswig-Holstein, Campus Kiel
Kiel, Schleswig-Holstein, 24105
Mark Ellrichmann, MD, 00494315972075, mark.ellrichmann@uksh.de
Stefan Schreiber, Prof., 00494315971272, s.schreiber@mucosa.de
About this study
Official title: 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.
Read more
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
- Being tested
- Food grade dye mucosal staining
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food grade dye mucosal stainingDietary supplement
mucosal staining with food grade dye
| Study group | Role | What they receive |
|---|---|---|
| Dye staining | Experimental | Food grade dye mucosal staining Receives: Dietary Supplement: Food grade dye mucosal staining |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of mucosal staining
Assessment of mucosal staining by questionnaire
Measured: Day of scheduled endoscopy
Secondary outcomes (2)
Number of patients with treatment related adverse events
Measured: Day of scheduled endoscopy and within 3 days after colonoscopy
Number of patients with detected adenomas
Measured: Day of scheduled endoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionJun 2023 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChromoendoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Schleswig-Holstein
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Ellrichmann, University Hospital Schleswig-Holstein
- Investigators
- Mark Ellrichmann, MD, Principal investigator, University Hospital Schleswig-HolsteinStefan Schreiber, Prof., Study director, University Hospital Schleswig-Holstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02631798
- Sponsor's protocol ID
- Microcapsule Chromo-122015
- Status last verified
- Jun 2022
- First submitted
- 4 Dec 2015
- Last updated
- 1 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mucosal Staining After Oral Administration of Food Grade Dyes in Subjects Undergoing Outpatients Colonoscopy
- ClinicalTrials.gov ID
- NCT02631798
- Acronym / sponsor ID
- Microcapsule Chromo-122015
- Conditions
- Chromoendoscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital Schleswig-HolsteinUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 16 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dye staining | Experimental | Dietary Supplement: Food grade dye mucosal stainingFood grade dye mucosal staining |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Food grade dye mucosal stainingmucosal staining with food grade dye | Dietary supplement | Dye staining |
Primary outcome
Quality of mucosal staining
Time frame: Day of scheduled endoscopy
Assessment of mucosal staining by questionnaire
2 secondary outcomes
Number of patients with treatment related adverse events
Time frame: Day of scheduled endoscopy and within 3 days after colonoscopy
Number of patients with detected adenomas
Time frame: Day of scheduled endoscopy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Ellrichmann, MD principal investigator
University Hospital Schleswig-Holstein
Stefan Schreiber, Prof. study director
University Hospital Schleswig-Holstein
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food grade dye mucosal staining in people with Chromoendoscopy, run by University Hospital Schleswig-Holstein at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mark Ellrichmann, MD (00494315972075, mark.ellrichmann@uksh.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of mucosal staining (time frame: Day of scheduled endoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2022.