ClinicalTrials.gg
Status unknownNCT01504048Updated Aug 6, 2015

Usefulness of Chromoendoscopy in Diagnosing Microscopic Colitis

An interventional study of Colonoscopy with Indigo-Carmine Chromoendoscopy in Chronic Diarrhoea, Lymphocytic Colitis and Collagenous Colitis, sponsored by Karolinska University Hospital. Status unknown at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-08-06.

Sponsored by Karolinska University Hospital · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Aug 2015), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Chronic Diarrhoea
  • Lymphocytic Colitis
  • Collagenous Colitis

Keywords

  • Microscopic colitis
  • Intestinal Diseases
  • Inflammatory Bowel Diseases
03

In context

Colitis, Microscopic

23 studies on the registry are indexed under Colitis, Microscopic; 6 are open to participants now.

This study's planned enrollment of 150 is above the median of 47 across 14 interventional studies indexed under Colitis, Microscopic.

Browse Colitis, Microscopic studies →

Lead sponsor

Karolinska University Hospital is the lead sponsor of 279 studies on the registry; 55 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with chronic non-bloody diarrhea for at least one month

Exclusion criteria

Exclusion Criteria:

  • Patients who decline to participate
  • Unable to give
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    Chromoendoscopy

    Procedure: Colonoscopy with Indigo-Carmine Chromoendoscopy

Interventions

  • ProcedureColonoscopy with Indigo-Carmine Chromoendoscopy

    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.

    Also known as: Indigo-Carmine

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 12 month

07

Study locations

1 of 1 sites recruiting
  • Karoliniska University Hospital, Dept. of Gastroenterology
    Stockholm, 17176, Sweden
    Recruiting
    • Peter T Schmidt, MD, PhD · Contactpeter.thelin.schmidt@ki.se · +46 8 51770000
    • Peter T Schmidt, MD, PhD · Principal investigator
08

References and documents

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 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2009, a primary completion of Jun 2016 and a completion of Dec 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 29, 2011
First posted
Jan 5, 2012
Start
Jun 2009
Primary completionEst.
Jun 2016
CompletionEst.
Dec 2016
Last update
Aug 6, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 6, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01504048
Responsible party
Peter Thelin Schmidt (Head of Endoscopy, Karolinska University Hospital) — Principal investigator
First posted
Jan 5, 2012
Start date
Jun 2009
Primary completion
Jun 2016 (estimated)
Completion
Dec 2016 (estimated)
Last update
Aug 6, 2015

Study contacts

Peter T Schmidt, MD, PhD
Contact
peter.thelin.schmidt@ki.se
+46 8 51770000
Peter T Schmidt, MD, PhD
principal investigator · Karolinska University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion