Ulcerative ColitisNCT00213330
Cerebral Resonance Magnetic Imaging During Rectal Distention
An observational study of Ulcerative Colitis and Irritable Bowel Syndrome, run by University Hospital, Rouen at 1 site in France.
Trial summary
Irritable bowel syndrome is responsible for chronic abdominal pain, diarrhea and/or constipation. It is a very frequent problem. However, the exact cause of irritable bowel syndrome remains unknown. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ulcerative Colitis, Irritable Bowel Syndrome
- What is being tested?
- rectal distension
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2003to Feb 2006
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: healthy subjects and patients with irritable bowel syndrome
Who may be able to join
- healthy subjects irritable bowel syndrome (Rome II criteria) colitis ulcerative
Who cannot join
- pregnant or breast feeding metallic material implanted good tolerance of rectal distension acute phase of ulcerative colitis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cerebral Activity During Rectal Pain in Patients With Irritable Bowel Syndrome or Inflammatory Bowel Disease:Resonance Magnetic Imaging Study.
Irritable bowel syndrome is responsible for chronic abdominal pain, diarrhea and/or constipation. It is a very frequent problem. However, the exact cause of irritable bowel syndrome remains unknown. The purpose of this study is to look for a different cerebral response by magnetic resonance imaging after rectal stimulation in patients with irritable bowel syndrome compared to healthy subjects and to patients with digestive organic disease. Our hypothesis is that irritable bowel syndrome could be a problem of cerebral integration of visceral stimulation.
- Conditions
- Ulcerative Colitis, Irritable Bowel Syndrome
- Being tested
- rectal distension
- Keywords
- cerebral activity, rectal distension, colitis ulcerative, irritable bowel syndrome, magnetic resonance imaging
- Medical subject headings
- Colitis, Ulcerative, Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rectal distensionProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startApr 2003
- Study completionFeb 2006
Why it stopped: patients with inflammatory colitis not included
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanuel Gérardin, MD, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00213330
- Sponsor's protocol ID
- 2001/105/HP
- Status last verified
- Apr 2012
- First submitted
- 13 Sep 2005
- Last updated
- 23 Apr 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Activity During Rectal Pain in Patients With Irritable Bowel Syndrome or Inflammatory Bowel Disease:Resonance Magnetic Imaging Study.
- ClinicalTrials.gov ID
- NCT00213330
- Acronym / sponsor ID
- 2001/105/HP
- Conditions
- Ulcerative Colitis, Irritable Bowel Syndrome
- Keywords
- cerebral activity, rectal distension, colitis ulcerative, irritable bowel syndrome, magnetic resonance imaging
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: patients with inflammatory colitis not included
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- Apr 2003
- Study completion
- Feb 2006
- First posted
- 21 Sep 2005 (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.
Irritable bowel syndrome is responsible for chronic abdominal pain, diarrhea and/or constipation. It is a very frequent problem. However, the exact cause of irritable bowel syndrome remains unknown. The purpose of this study is to look for a different cerebral response by magnetic resonance imaging after rectal stimulation in patients with irritable bowel syndrome compared to healthy subjects and to patients with digestive organic disease. Our hypothesis is that irritable bowel syndrome could be a problem of cerebral integration of visceral stimulation.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- healthy subjects and patients with irritable bowel syndrome
Key inclusion criteria (1 listed)
- healthy subjects irritable bowel syndrome (Rome II criteria) colitis ulcerative
Key exclusion criteria (1 listed)
- pregnant or breast feeding metallic material implanted good tolerance of rectal distension acute phase of ulcerative colitis
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 |
|---|---|---|
| rectal distension | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2012.
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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.
Emmanuel Gérardin, MD principal investigator
University Hospital, Rouen
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 Ulcerative Colitis and Irritable Bowel Syndrome, run by University Hospital, Rouen at 1 site in France.
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 1 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: withdrawn, as of the sponsor's last update on 23 Apr 2012. 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 France. 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 was withdrawn before enrolling participants, so there are no results.
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.
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 23 Apr 2012.