Colitis, MicroscopicNCT02699333
Risk Factors for Microscopic Colitis
An observational study of Colitis, Microscopic, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
Microscopic colitis is a common cause of watery diarrhea, particularly in the elderly. Although the incidence is comparable to ulcerative colitis and Crohn's disease, the etiology is unknown. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Colitis, Microscopic
- How many people
- 346 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2016to 24 Dec 2020
- Phase
- Observational
- 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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who undergo colonoscopy for diarrhea at the University of North Carolina
Who may be able to join
- Colonoscopy for diarrhea
Who cannot join
- Fewer than 4 loose bowel movements per day.
- Failure to visualize the entire colon to the cecum or preparation less than good or excellent.
- Age under 35 years. There will be no upper age limit.
- Inability to understand and cooperate with the interview.
- Indication for colonoscopy other than diarrhea.
- Prior history of inflammatory bowel disease (Crohn's disease or ulcerative colitis).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina
Chapel Hill, North Carolina, 27599-7555
About this study
Microscopic colitis is a common cause of watery diarrhea, particularly in the elderly. Although the incidence is comparable to ulcerative colitis and Crohn's disease, the etiology is unknown. Understanding the etiology of microscopic colitis is an important step in developing logical interventions to decrease the burden from microscopic colitis. This research could provide critical insights into the etiology of this poorly studied condition.
Read the detailed description
Microscopic colitis (MC) is a chronic condition that is a common cause of watery diarrhea, particularly in the elderly. The etiology is unknown but widely considered to be an abnormal immune reaction to luminal antigens in predisposed hosts. Drugs and autoimmunity have also been implicated. The aims of the study are: 1) To quantitatively classify microscopic colitis using image analysis microscopy to determine whether the degree of lymphocytic infiltration correlates with etiology, symptoms and prognosis. 2) To investigate the etiology of microscopic colitis by examining medical and lifestyle risk factors including medications, autoimmunity, diet, and smoking 3) To evaluate the association between the adherent microbial flora and MC to assess whether bacterial dysbiosis is linked to presence of MC. As an exploratory aim we will evaluate whether CYP2C19 polymorphisms are more common in purportedly drug-induced disease since the diverse drugs that have been associated with MC are all substrates for this gene.
To conduct the study the investigators will obtain detailed dietary, medical and lifestyle information on study subjects who undergo complete colonoscopy for diarrhea. The investigators will obtain colon biopsies from the right, transverse and left colon to evaluate adherent bacterial organisms. The investigators will draw blood to evaluate CYP2C19 polymorphisms and for future genetic studies. The prospective design corrects important limitations of prior research on MC. Successful completion of the study aims will improve the understanding of risk factors, set the stage for more scientifically grounded future research, and potentially suggest new interventions for a disease that is currently poorly understood.
- Conditions
- Colitis, Microscopic
- Medical subject headings
- Colitis, Microscopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Microscopic colitis cases | Patients found to have microscopic colitis based on colonic biopsies. | |
| Controls | Patients who meet eligibility requirements but do not have microscopic colitis on biopsy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microscopic Colitis
Microscopic colitis defined by increased lymphocytes or collagen
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2016 (estimated)
- Study start1 May 2016
- Primary completion24 Dec 2020
- Study completion24 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colitis, MicroscopicStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 346 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert S. Sandler, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02699333
- Sponsor's protocol ID
- 14-3156
- Status last verified
- Feb 2021
- First submitted
- 23 Feb 2016
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Microscopic Colitis
- ClinicalTrials.gov ID
- NCT02699333
- Acronym / sponsor ID
- 14-3156
- Conditions
- Colitis, Microscopic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 346 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- 1 May 2016 (actual)
- Primary completion
- 24 Dec 2020 (actual)
- Study completion
- 24 Dec 2020 (actual)
- First posted
- 4 Mar 2016 (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.
Microscopic colitis is a common cause of watery diarrhea, particularly in the elderly. Although the incidence is comparable to ulcerative colitis and Crohn's disease, the etiology is unknown. Understanding the etiology of microscopic colitis is an important step in developing logical interventions to decrease the burden from microscopic colitis. This research could provide critical insights into the etiology of this poorly studied condition.
Detailed description
Microscopic colitis (MC) is a chronic condition that is a common cause of watery diarrhea, particularly in the elderly. The etiology is unknown but widely considered to be an abnormal immune reaction to luminal antigens in predisposed hosts. Drugs and autoimmunity have also been implicated. The aims of the study are: 1) To quantitatively classify microscopic colitis using image analysis microscopy to determine whether the degree of lymphocytic infiltration correlates with etiology, symptoms and prognosis. 2) To investigate the etiology of microscopic colitis by examining medical and lifestyle risk factors including medications, autoimmunity, diet, and smoking 3) To evaluate the association between the adherent microbial flora and MC to assess whether bacterial dysbiosis is linked to presence of MC. As an exploratory aim we will evaluate whether CYP2C19 polymorphisms are more common in purportedly drug-induced disease since the diverse drugs that have been associated with MC are all substrates for this gene.
To conduct the study the investigators will obtain detailed dietary, medical and lifestyle information on study subjects who undergo complete colonoscopy for diarrhea. The investigators will obtain colon biopsies from the right, transverse and left colon to evaluate adherent bacterial organisms. The investigators will draw blood to evaluate CYP2C19 polymorphisms and for future genetic studies. The prospective design corrects important limitations of prior research on MC. Successful completion of the study aims will improve the understanding of risk factors, set the stage for more scientifically grounded future research, and potentially suggest new interventions for a disease that is currently poorly understood.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Microscopic colitis cases | – | –Patients found to have microscopic colitis based on colonic biopsies. |
| Controls | – | –Patients who meet eligibility requirements but do not have microscopic colitis on biopsy. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who undergo colonoscopy for diarrhea at the University of North Carolina
Key inclusion criteria (1 listed)
- Colonoscopy for diarrhea
Key exclusion criteria (6 listed)
- Fewer than 4 loose bowel movements per day.
- Failure to visualize the entire colon to the cecum or preparation less than good or excellent.
- Age under 35 years. There will be no upper age limit.
- Inability to understand and cooperate with the interview.
- Indication for colonoscopy other than diarrhea.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Microscopic Colitis
Time frame: Day 1
Microscopic colitis defined by increased lymphocytes or collagen
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 21 Feb 2021.
- Individual participant dataSharing planned: Undecided
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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.
Robert S. Sandler, MD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colitis, Microscopic, run by University of North Carolina, Chapel Hill at 1 site in United States.
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 6 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 21 Feb 2021. 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 United States. 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?
Microscopic Colitis (time frame: Day 1). 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 21 Feb 2021.