Inflammatory Bowel DiseasesSTRIDENTNCT03218202
Stricture Definition and Treatment (STRIDENT) Observational Study.
An observational study of Inflammatory Bowel Diseases and Crohn Disease, run by St Vincent's Hospital Melbourne at 1 site in Australia.
Trial summary
Two thirds of patients with Crohn's disease require intestinal surgery at some time in their life. Intestinal strictures, that is narrowing of the bowel due to inflammation and scarring, are the most common reason for surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis
- How many people
- 9 participants
- Where
- 1 siteAustralia
- Study dates
- 9 Oct 2017to 29 Aug 2019
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with inflammatory bowel disease (Crohn's Disease or Ulcerative Colitis) without symptoms who are incidentally found to have a stricture on CT, MRI or endoscopy.
Who may be able to join
- Inflammatory bowel disease patients with intestinal stricture(s) identified on CT, MRI or endoscopy but without associated symptoms
Who cannot join
- Low rectal or anal strictures
- Evidence of dysplasia or malignancy from stricture biopsies or adjacent mucosal biopsies
- Patients for whom endoscopy is not suitable due to co-morbidities or clinical state
- Inability to give informed consent
- Suspected perforation of the gastrointestinal tract
- Inability to undergo MRI small bowel due to a contraindication.
Trial locations and contacts
1 site in 1 country.
About this study
Two thirds of patients with Crohn's disease require intestinal surgery at some time in their life. Intestinal strictures, that is narrowing of the bowel due to inflammation and scarring, are the most common reason for surgery. Despite the high frequency, associated disability, and cost there are no are no treatment strategies that aim to improve the outcome of this disease complication. The STRIDENT (stricture definition and treatment) studies aim to determine biochemical and imaging features associated with the development of strictures and in related STRIDENT studies develop strategies for treatment.
Read the detailed description
Patients with asymptomatic Crohn's disease strictures will be followed prospectively for 12 months using imaging (including MRI/intestinal ultrasound) and biochemical analyses (including CRP/calprotectin). Patient's with symptomatic or asymptomatic ulcerative colitis related strictures will be followed similarly. Risk factors for progression of strictures and development of symptoms will be identified.
- Keywords
- Inflammatory Bowel Disease, Crohn Disease, Ulcerative Colitis, Intestinal stricture
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative, Constriction, Pathologic
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of symptoms
Number of patients who develop symptoms and require step up in therapy (drug, endoscopic or surgical therapy).
Measured: 12 months
Secondary outcomes (6)
Imaging features associated with development of symptoms (MRI).
MaRIA
Measured: 12 months
Imaging features associated with development of symptoms (Intestinal Ultrasound).
Limberg's score
Measured: 12 months
Biochemical features associated with development of symptoms
CRP and calprotectin
Measured: 12 months
Patient reported outcomes
SF36
Measured: 12 months
Patient reported outcomes
IBDQ
Measured: 12 months
Requirement for step up in drug therapy
Need for additional drug therapy due to development of symptoms
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2017
- Study start9 Oct 2017
- Primary completion29 Aug 2019
- Study completion29 Aug 2019
Why it stopped: To focus on STRIDENT intervention studies as this study population is heterogenous
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- St Vincent's Hospital Melbourne
- Sponsor type
- University, hospital or other
- Collaborators
- Australasian Gastro Intestinal Research Foundation
- Responsible party
- Principal investigator, Michael Kamm, St Vincent's Hospital Melbourne
- Investigators
- Emily Wright, MBBS PhD, Principal investigator, St Vincent's Hospital MelbourneBronte Holt, MBBS PhD, Principal investigator, St Vincent's Hospital MelbourneMichael Kamm, MBBS PhD, Principal investigator, St Vincent's Hospital Melbourne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03218202
- Sponsor's protocol ID
- SVHMelbourneSTRIDENT3
- Acronym
- STRIDENT
- Status last verified
- Aug 2019
- First submitted
- 7 Jul 2017
- Last updated
- 3 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stricture Definition and Treatment (STRIDENT) Observational Study.
- ClinicalTrials.gov ID
- NCT03218202
- Acronym / sponsor ID
- STRIDENT / SVHMelbourneSTRIDENT3
- Keywords
- Inflammatory Bowel Disease, Crohn Disease, Ulcerative Colitis, Intestinal stricture
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: To focus on STRIDENT intervention studies as this study population is heterogenous
- Enrolment
- 9 participants (actual)
- Lead sponsor
- St Vincent's Hospital MelbourneUniversity, hospital or other
- Collaborators
- Australasian Gastro Intestinal Research Foundation
- Study start
- 9 Oct 2017 (actual)
- Primary completion
- 29 Aug 2019 (actual)
- Study completion
- 29 Aug 2019 (actual)
- First posted
- 14 Jul 2017 (actual)
- 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.
Two thirds of patients with Crohn's disease require intestinal surgery at some time in their life. Intestinal strictures, that is narrowing of the bowel due to inflammation and scarring, are the most common reason for surgery. Despite the high frequency, associated disability, and cost there are no are no treatment strategies that aim to improve the outcome of this disease complication. The STRIDENT (stricture definition and treatment) studies aim to determine biochemical and imaging features associated with the development of strictures and in related STRIDENT studies develop strategies for treatment.
Detailed description
Patients with asymptomatic Crohn's disease strictures will be followed prospectively for 12 months using imaging (including MRI/intestinal ultrasound) and biochemical analyses (including CRP/calprotectin). Patient's with symptomatic or asymptomatic ulcerative colitis related strictures will be followed similarly. Risk factors for progression of strictures and development of symptoms will be identified.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with inflammatory bowel disease (Crohn's Disease or Ulcerative Colitis) without symptoms who are incidentally found to have a stricture on CT, MRI or endoscopy.
Key inclusion criteria (1 listed)
- Inflammatory bowel disease patients with intestinal stricture(s) identified on CT, MRI or endoscopy but without associated symptoms
Key exclusion criteria (6 listed)
- Low rectal or anal strictures
- Evidence of dysplasia or malignancy from stricture biopsies or adjacent mucosal biopsies
- Patients for whom endoscopy is not suitable due to co-morbidities or clinical state
- Inability to give informed consent
- Suspected perforation of the gastrointestinal tract
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
Development of symptoms
Time frame: 12 months
Number of patients who develop symptoms and require step up in therapy (drug, endoscopic or surgical therapy).
6 secondary outcomes
Imaging features associated with development of symptoms (MRI).
Time frame: 12 months
Imaging features associated with development of symptoms (Intestinal Ultrasound).
Time frame: 12 months
Biochemical features associated with development of symptoms
Time frame: 12 months
Patient reported outcomes
Time frame: 12 months
Patient reported outcomes
Time frame: 12 months
Requirement for step up in drug therapy
Time frame: 12 months
Results and safety
The study was stopped early (reason given: To focus on STRIDENT intervention studies as this study population is heterogenous). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2019.
- 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.
Emily Wright, MBBS PhD principal investigator
St Vincent's Hospital Melbourne
Bronte Holt, MBBS PhD principal investigator
St Vincent's Hospital Melbourne
Michael Kamm, MBBS PhD principal investigator
St Vincent's Hospital Melbourne
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 Inflammatory Bowel Diseases and Crohn Disease, run by St Vincent's Hospital Melbourne at 1 site in Australia.
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: stopped early, as of the sponsor's last update on 3 Sep 2019. 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 Australia. 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 stopped early (reason given: To focus on STRIDENT intervention studies as this study population is heterogenous). Results are not available in the source record.
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?
Development of symptoms (time frame: 12 months). 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 3 Sep 2019.