Microscopic ColitisNCT02303132
Ussing Experiments to Evaluate the Role of Medication-induced Microscopic Colitis
A study testing Ussing experiment in people with Microscopic Colitis, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Medication use, especially NSAIDs and PPIs, prior to diagnosis is considered a risk factor for MC development. However, the exact pathophysiological mechanism is unclear. It is hypothesized that NSAIDs, PPIs, and SSRIs may have an effect on the colon permeability, due to an idiosyncratic reaction which results in a… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Microscopic Colitis
- What is being tested?
- Ussing experiment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2015to Jul 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The indication for colonoscopy is a relapse of MC (active) / MC in remission (remission) / no MC (control)
- Patient is not treated with NSAIDs / PPI / SSRI in week before inclusion
Who cannot join
- Age below 18 years at the time of diagnosis
- Use of anticoagulants or immunosuppressive drugs
- Severe co-morbidities hindering an endoscopic procedure
- A previous history of any type of chronic colitis, IBS, IBD, colon carcinoma or (partial) colectomy
- A recent (last year) diagnosis of infectious diarrhea or radiation proctitis.
- Use of medication known to influence intestinal permeability
- Excessive alcohol usage (>20 standard units per week)
- Not capable of signing an informed consent
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Center
Maastricht, 6229 HX
About this study
Official title: Ex Vivo Experiments to Evaluate the Role of Medication on the Colon Permeability in Microscopic Colitis
Medication use, especially NSAIDs and PPIs, prior to diagnosis is considered a risk factor for MC development. However, the exact pathophysiological mechanism is unclear. It is hypothesized that NSAIDs, PPIs, and SSRIs may have an effect on the colon permeability, due to an idiosyncratic reaction which results in a local immune response. MC patients are considered to be susceptible hosts, prone to react on administration of abovementioned drugs. In order to test this hypothesis and to generate new insights in the pathophysiology of MC, we want to perform an Ussing chamber experiment using fresh colon tissue samples. The primary objective is to assess ex vivo the effect of NSAIDs and PPIs on epithelial permeability of colon biopsy specimens of MC and non-MC patients, using the Ussing chamber system
- Conditions
- Microscopic Colitis
- Being tested
- Ussing experiment
- Medical subject headings
- Colitis, Microscopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ussing experimentOther
fresh colon mucosa (biopsy) of all participants will be mounted in an Ussing chamber and exposed to NSAIDs / PPI / control.
| Study group | Role | What they receive |
|---|---|---|
| Active MC | Other | Patients with active MC will be included Receives: Other: Ussing experiment |
| MC in remission | Other | Patients with MC in remission will be included Receives: Other: Ussing experiment |
| Controls | Other | Patients without MC will be included Receives: Other: Ussing experiment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Transepithelial electircal resistance
Measured: 2 hours
Secondary outcomes (1)
Change in permeation of a fluorescent marker
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2014 (estimated)
- Study startNov 2015
- Primary completionJun 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microscopic ColitisStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- A Masclee, PhD, Study chair, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02303132
- Sponsor's protocol ID
- NL48505.068.14
- Status last verified
- Jul 2016
- First submitted
- 25 Nov 2014
- Last updated
- 19 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ex Vivo Experiments to Evaluate the Role of Medication on the Colon Permeability in Microscopic Colitis
- ClinicalTrials.gov ID
- NCT02303132
- Acronym / sponsor ID
- NL48505.068.14
- Conditions
- Microscopic Colitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 27 Nov 2014 (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.
Medication use, especially NSAIDs and PPIs, prior to diagnosis is considered a risk factor for MC development. However, the exact pathophysiological mechanism is unclear. It is hypothesized that NSAIDs, PPIs, and SSRIs may have an effect on the colon permeability, due to an idiosyncratic reaction which results in a local immune response. MC patients are considered to be susceptible hosts, prone to react on administration of abovementioned drugs. In order to test this hypothesis and to generate new insights in the pathophysiology of MC, we want to perform an Ussing chamber experiment using fresh colon tissue samples. The primary objective is to assess ex vivo the effect of NSAIDs and PPIs on epithelial permeability of colon biopsy specimens of MC and non-MC patients, using the Ussing chamber system
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active MC | Other | Other: Ussing experimentPatients with active MC will be included |
| MC in remission | Other | Other: Ussing experimentPatients with MC in remission will be included |
| Controls | Other | Other: Ussing experimentPatients without MC will be included |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The indication for colonoscopy is a relapse of MC (active) / MC in remission (remission) / no MC (control)
- Patient is not treated with NSAIDs / PPI / SSRI in week before inclusion
Key exclusion criteria (8 listed)
- Age below 18 years at the time of diagnosis
- Use of anticoagulants or immunosuppressive drugs
- Severe co-morbidities hindering an endoscopic procedure
- A previous history of any type of chronic colitis, IBS, IBD, colon carcinoma or (partial) colectomy
- A recent (last year) diagnosis of infectious diarrhea or radiation proctitis.
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 |
|---|---|---|
| Ussing experimentfresh colon mucosa (biopsy) of all participants will be mounted in an Ussing chamber and exposed to NSAIDs / PPI / control. | Other | Active MC, Controls, MC in remission |
Primary outcome
Change in Transepithelial electircal resistance
Time frame: 2 hours
1 secondary outcome
Change in permeation of a fluorescent marker
Time frame: 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2016.
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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.
A Masclee, PhD study chair
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ussing experiment in people with Microscopic Colitis, run by Maastricht University Medical Center at 1 site in Netherlands.
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 2 inclusion and 8 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: finished, as of the sponsor's last update on 19 Jul 2016. 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 Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Transepithelial electircal resistance (time frame: 2 hours). 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 19 Jul 2016.