Chronic DiarrhoeaNCT01504048
Usefulness of Chromoendoscopy in Diagnosing Microscopic Colitis
A study testing Colonoscopy with Indigo-Carmine Chromoendoscopy in people with Chronic Diarrhoea and Lymphocytic Colitis, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
The purpose of this study is to determine whether chromoendoscopy using Indigo-Carmine dye spray is useful in diagnosing microscopic colitis among patients undergoing colonoscopy due to chronic watery diarrhea. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Diarrhoea, Lymphocytic Colitis, Collagenous Colitis
- What is being tested?
- Colonoscopy with Indigo-Carmine Chromoendoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSweden
- Study dates
- Jun 2009to Dec 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with chronic non-bloody diarrhea for at least one month
Who cannot join
- Patients who decline to participate
- Unable to give informed consent
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Karoliniska University Hospital, Dept. of Gastroenterology
Stockholm, 17176
Peter T Schmidt, MD, PhD, +46 8 51770000, peter.thelin.schmidt@ki.se
Peter T Schmidt, MD, PhD
About this study
Official title: Prospective Study on the Usefulness of Chromoendoscopy in Detecting Microscopic Colitis in Patients Undergoing Colonoscopy Due to Chronic Watery Diarrhoea
The purpose of this study is to determine whether chromoendoscopy using Indigo-Carmine dye spray is useful in diagnosing microscopic colitis among patients undergoing colonoscopy due to chronic watery diarrhea.
Read the detailed description
Microscopic colitis is a common disease found in 10% to 20% of cases having chronic watery diarrhea. Obvious endoscopically identifiable changes of the mucosal surface are usually absent, thus diagnosing microscopic colitis relies on multiple biopsy sampling from all segments of the colon. Chromoendoscopy using indigo-carmine dye spray might, however, unravel mucosal changes in microscopic colitis (Suzuki 2011).
The aim of this study is to investigate if chromoendoscopy using Indigo-Carmine 0.2-0.5% in patients with chronic watery diarrhea is useful in diagnosing microscopic colitis.
- Conditions
- Chronic Diarrhoea, Lymphocytic Colitis, Collagenous Colitis
- Being tested
- Colonoscopy with Indigo-Carmine Chromoendoscopy
- Keywords
- Microscopic colitis, Intestinal Diseases, Inflammatory Bowel Diseases
- Medical subject headings
- Colitis, Lymphocytic, Colitis, Collagenous, Colitis, Microscopic, Intestinal Diseases, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colonoscopy with Indigo-Carmine ChromoendoscopyProcedure or surgery
Also called Indigo-Carmine
Colonoscopy with chromoendoscopy using 0.2-0.5% Indigo-Carmine solution sprayed in five areas of the large intestine: Cecum, ascending colon, transverse colon, descending colon and rectum. Pictures are taken before and after dye-spraying and biopsies are collected from all segments of the large intestine and rectum.
| Study group | Role | What they receive |
|---|---|---|
| Chromoendoscopy | Experimental | Not described Receives: Procedure: Colonoscopy with Indigo-Carmine Chromoendoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of microscopic colitis using chromoendoscopy
To investigate the usefullness of chromoendoscopy in diagnosing microscopic colitis using 0.2-0.5% Indigo-Carmine dye spray. The golden standard is the results of histological examination of biopsies from the colo-rectal mucosa.
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2012 (estimated)
- Study startJun 2009
- Primary completionJun 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic DiarrhoeaStudies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe sponsor's other registered studies.
- 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Thelin Schmidt, Karolinska University Hospital
- Investigators
- Peter T Schmidt, MD, PhD, Principal investigator, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01504048
- Sponsor's protocol ID
- PTS-02
- Status last verified
- Aug 2015
- First submitted
- 29 Dec 2011
- Last updated
- 6 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Suzuki G, Mellander MR, Suzuki A, Rubio CA, Lambert R, Bjork J, Schmidt PT. Usefulness of colonoscopic examination with indigo carmine in diagnosing microscopic colitis. Endoscopy. 2011 Dec;43(12):1100-4. doi: 10.1055/s-0031-1291423. Epub 2011 Nov 4.
PubMed 22057822
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study on the Usefulness of Chromoendoscopy in Detecting Microscopic Colitis in Patients Undergoing Colonoscopy Due to Chronic Watery Diarrhoea
- ClinicalTrials.gov ID
- NCT01504048
- Acronym / sponsor ID
- PTS-02
- Conditions
- Chronic Diarrhoea, Lymphocytic Colitis, Collagenous Colitis
- Keywords
- Microscopic colitis, Intestinal Diseases, Inflammatory Bowel Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 5 Jan 2012 (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.
The purpose of this study is to determine whether chromoendoscopy using Indigo-Carmine dye spray is useful in diagnosing microscopic colitis among patients undergoing colonoscopy due to chronic watery diarrhea.
Detailed description
Microscopic colitis is a common disease found in 10% to 20% of cases having chronic watery diarrhea. Obvious endoscopically identifiable changes of the mucosal surface are usually absent, thus diagnosing microscopic colitis relies on multiple biopsy sampling from all segments of the colon. Chromoendoscopy using indigo-carmine dye spray might, however, unravel mucosal changes in microscopic colitis (Suzuki 2011).
The aim of this study is to investigate if chromoendoscopy using Indigo-Carmine 0.2-0.5% in patients with chronic watery diarrhea is useful in diagnosing microscopic colitis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chromoendoscopy | Experimental | Procedure: Colonoscopy with Indigo-Carmine Chromoendoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with chronic non-bloody diarrhea for at least one month
Key exclusion criteria (2 listed)
- Patients who decline to participate
- Unable to give informed consent
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 |
|---|---|---|
| Colonoscopy with Indigo-Carmine ChromoendoscopyAlso: Indigo-CarmineColonoscopy with chromoendoscopy using 0.2-0.5% Indigo-Carmine solution sprayed in five areas of the large intestine: Cecum, ascending colon, transverse colon, descending colon and rectum. Pictures are taken before and after dye-spraying and biopsies are collected from all segments of the large intestine and rectum. | Procedure or surgery | Chromoendoscopy |
Primary outcome
Detection of microscopic colitis using chromoendoscopy
Time frame: 12 month
To investigate the usefullness of chromoendoscopy in diagnosing microscopic colitis using 0.2-0.5% Indigo-Carmine dye spray. The golden standard is the results of histological examination of biopsies from the colo-rectal mucosa.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2015.
- Background: PubMed 22057822Suzuki G, Mellander MR, Suzuki A, Rubio CA, Lambert R, Bjork J, Schmidt PT. Usefulness of colonoscopic examination with indigo carmine in diagnosing microscopic colitis. Endoscopy. 2011 Dec;43(12):1100-4. doi: 10.1055/s-0031-1291423. Epub 2011 Nov 4.
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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.
Peter T Schmidt, MD, PhD principal investigator
Karolinska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colonoscopy with Indigo-Carmine Chromoendoscopy in people with Chronic Diarrhoea and Lymphocytic Colitis, run by Karolinska University Hospital at 1 site in Sweden.
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 1 inclusion and 2 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 6 Aug 2015. 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 Sweden. 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 Peter T Schmidt, MD, PhD (+46 8 51770000, peter.thelin.schmidt@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of microscopic colitis using chromoendoscopy (time frame: 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01504048, which also lists 1 linked publication.
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 6 Aug 2015.