An interventional study of Budesonide and Bismuth in Colitis, sponsored by Norwegian University of Science and Technology. Terminated at 9 sites in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-01-21.
Sponsored by Norwegian University of Science and Technology · Not applicable, Interventional, and Treatment
The study compares the effect of Budesonide, Bismuth and fiber in patients with microscopic colitis
This randomized, controlled, open study compares the effects of 8 weeks' treatment with Budesonide, Bismuth and fiber on symptoms and histological findings in patients with microscopic colitis (both collagenous colitis and lymphocytic colitis).
23 studies on the registry are indexed under Colitis, Microscopic; 6 are open to participants now.
This study's enrollment of 105 is above the median of 47 across 14 interventional studies indexed under Colitis, Microscopic.
Browse Colitis, Microscopic studies →Norwegian University of Science and Technology is the lead sponsor of 495 studies on the registry; 48 are open to participants now.
Compared within Colitis, Microscopic, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Colitis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
Exclusion Criteria:
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.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
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.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Budesonide 9mg
Drug: Budesonide
Bismuth mixture
Drug: Bismuth
Fiber preparation
Drug: Fiber
Budesonide 9 mg
Bismuth mixture
Fiber for control
Symptoms: Stool frequency and consistency
September 2010: Patient's enrollment completed. Data analysis ongoing.
Time frame: 2001 - 2011
Histological findings in biopsies from colon
Patient's enrollment completed. Data analysis ongoing.
Time frame: 2001 - 2011
The record gives a start of Nov 2001, a primary completion of Sep 2010 and a completion of Oct 2014. 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.
This study is terminated, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions 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.
Studies of the drugs tested here: Budesonide · Bismuth
Norwegian University of Science and Technology →