SpondyloarthropathiesSPONDILENDONCT00768950
The Characterization of Small Bowel and Colonic Involvement in Patients With Seronegative Spondyloarthritides
An observational study of Spondyloarthropathies, run by Carol Davila University of Medicine and Pharmacy at 1 site in Romania.
Trial summary
Up to 60% of patients with Seronegative Spondyloarthritides have inflammation in the colon or ileum. This is usually asymptomatic, but in 5 to 10% of patients with SA, Frank IBD will develop. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spondyloarthropathies
- What is being tested?
- Capsule endoscopy examination and Colonoscopy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 65 participants
- Where
- 1 siteRomania
- Study dates
- Jan 2008to Aug 2013
- 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 spondyloarthropathies (ankylosing spondylitis, reactive arthritis, psoriatic arthritis and spondylitis, enteropathic arthritis and spondylitis, juvenile-onset spondyloarthritis, and undifferentiated spondyloarthritis) reffered to a Universitary Clinic of Internal Medicine and Rheumatology
Who may be able to join
- signing of the inform consent
- subjects 18 years old or more
- patients with spondyloarthropathy as defined by the Amor criteria
Who cannot join
- presumed intestinal obstruction
- impaired deglutition
- cardiac pace-makers present
- pregnancy
- pelvic or abdominal radiotherapy anytime in the past
- major abdominal surgery anytime in the past
- major comorbidities which could represent a contraindication to a surgical abdominal intervention
Trial locations and contacts
1 site in 1 country.
Romania1 site
Gastroenterology Department, Colentina Clinical Hospital
Bucharest, 020125
About this study
Up to 60% of patients with Seronegative Spondyloarthritides have inflammation in the colon or ileum. This is usually asymptomatic, but in 5 to 10% of patients with SA, Frank IBD will develop. Lesions of the bowel could also be present in the SA patients because of the potential injury posed by the NSAIDS, a common used medication in this setting.
It is the bowel involvement in patients with SA that we propose to characterize, partly because there are scant communicated data in the medical literature, especially regarding small bowel lesions.
Read the detailed description
The Seronegative Spondyloarthritides (SA) are a group of disorders that share certain clinical features and an association with the hla-b27 allele, having also overlapping features with inflammatory bowel disease (IBD).
Up to 60% of patients have inflammation in the colon or ileum. This is usually asymptomatic, but in 5 to 10% of patients with SA, Frank IBD will develop.
Lesions of the bowel could also be present in the SA patients because of the potential injury posed by the NSAIDS, a common used medication in this setting.
On the other hand, biologics used to treat patients with SA are believed to favorably influence the small bowel lesions that are concomitantly present.
It is the bowel involvement in patients with SA that we propose to characterize, partly because there are scant communicated data in the medical literature.
The design of the proposed study involves performing one full colonoscopic examination (including ileoscopy) followed by one capsule endoscopy examination to the patients with SA. Prior to these examination, the patency of the gi tract will be tested using a patency capsule. If the patency of the gi tract is not confirmed, then the capsule endoscopy examination is abandoned.
Our aim is to explore about 100 patients in three years, thus having a close-to-reality "look" into the presence and extent of bowel involvement in the pool of the patients having SA; and also to characterize the lesions mainly depending on the treatment received, concomitant pathology and the form of the disease. We also aim to identify a relationship between the lesions found at colonoscopy and capsule endoscopy, the purpose being the possibility to predict one having only performed the other.
Thus, we hope to identify the therapeutic strategies that are most suited in the management of these patients.
- Conditions
- Spondyloarthropathies
- Being tested
- Capsule endoscopy examination, Colonoscopy
- Keywords
- Seronegative spondyloarthropathies, Endoscopic capsule examination, Small bowel and colon lesions, Nonsteroidal anti-inflammatory drugs, Anti TNF Alpha Drugs
- Medical subject headings
- Spondylarthropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capsule endoscopy examinationProcedure or surgery
Also called Given imaging capsule SB2
Examination of the small bowel with endoscopic videocapsule
ColonoscopyProcedure or surgery
Also called Olympus Evis Exera II videocolonoscope
Endoscopic examination of the large bowel and terminal ileum
| Study group | Role | What they receive |
|---|---|---|
| Spondyloarthropathies | Patients with spondyloarthropathies (ankylosing spondylitis, reactive arthritis, psoriatic arthritis and spondylitis, enteropathic arthritis and spondylitis, juvenile-onset spondyloarthritis, and undifferentiated spondyloarthritis) as defined by the AMOR criteria Receives: Procedure: Capsule endoscopy examination; Procedure: Colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with bowel lesions
Measured: July 2012
Secondary outcomes (1)
Correlation of the bowel lesions with patient status
Measured: July 2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2008 (estimated)
- Study startJan 2008
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SpondyloarthropathiesStudies 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
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carol Davila University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Collaborators
- EXECUTIVE UNIT FOR FINANCING HIGHER EDUCATION AND SCIENTIFIC UNIVERSITY RESEARCH, Clinical Hospital Colentina
- Responsible party
- Principal investigator, Prof. Dr. Mihail Radu Voiosu, Carol Davila University of Medicine and Pharmacy
- Investigators
- Mihail R Voiosu, M.D., Ph.D., Principal investigator, Carol Davila University of Medicine and PharmacyMihai Rimbas, M.D., Study chair, Carol Davila University of Medicine and Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00768950
- Sponsor's protocol ID
- UMFCD-Idei-320/2007
- Other IDs
- Idei-320/01-10-2007
- Acronym
- SPONDILENDO
- Status last verified
- Aug 2013
- First submitted
- 7 Oct 2008
- Last updated
- 14 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rimbas M, Marinescu M, Voiosu MR. Bowel lesions in spondyloarthritides. Rom J Intern Med. 2009;47(1):75-85.
PubMed 19886073Rimbas M, Marinescu M, Voiosu MR, Baicus CR, Caraiola S, Nicolau A, Nitescu D, Badea GC, Parvu MI. NSAID-induced deleterious effects on the proximal and mid small bowel in seronegative spondyloarthropathy patients. World J Gastroenterol. 2011 Feb 28;17(8):1030-5. doi: 10.3748/wjg.v17.i8.1030.
PubMed 21448355Chitul A, Voiosu AM, Marinescu M, Caraiola S, Nicolau A, Badea GC, Parvu MI, Ionescu RA, Mateescu BR, Voiosu MR, Baicus CR, Rimbas M. Different effects of anti-TNF-alpha biologic drugs on the small bowel macroscopic inflammation in patients with ankylosing spondylitis. Rom J Intern Med. 2017 Mar 1;55(1):44-52. doi: 10.1515/rjim-2017-0001.
PubMed 28103201
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Characterization of Small Bowel and Colonic Involvement in Patients With Seronegative Spondyloarthritides
- ClinicalTrials.gov ID
- NCT00768950
- Acronym / sponsor ID
- SPONDILENDO / UMFCD-Idei-320/2007
- Conditions
- Spondyloarthropathies
- Keywords
- Seronegative spondyloarthropathies, Endoscopic capsule examination, Small bowel and colon lesions, Nonsteroidal anti-inflammatory drugs, Anti TNF Alpha Drugs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Carol Davila University of Medicine and PharmacyUniversity, hospital or other
- Collaborators
- EXECUTIVE UNIT FOR FINANCING HIGHER EDUCATION AND SCIENTIFIC UNIVERSITY RESEARCH, Clinical Hospital Colentina
- Study start
- Jan 2008
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 8 Oct 2008 (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.
Up to 60% of patients with Seronegative Spondyloarthritides have inflammation in the colon or ileum. This is usually asymptomatic, but in 5 to 10% of patients with SA, Frank IBD will develop. Lesions of the bowel could also be present in the SA patients because of the potential injury posed by the NSAIDS, a common used medication in this setting.
It is the bowel involvement in patients with SA that we propose to characterize, partly because there are scant communicated data in the medical literature, especially regarding small bowel lesions.
Detailed description
The Seronegative Spondyloarthritides (SA) are a group of disorders that share certain clinical features and an association with the hla-b27 allele, having also overlapping features with inflammatory bowel disease (IBD).
Up to 60% of patients have inflammation in the colon or ileum. This is usually asymptomatic, but in 5 to 10% of patients with SA, Frank IBD will develop.
Lesions of the bowel could also be present in the SA patients because of the potential injury posed by the NSAIDS, a common used medication in this setting.
On the other hand, biologics used to treat patients with SA are believed to favorably influence the small bowel lesions that are concomitantly present.
It is the bowel involvement in patients with SA that we propose to characterize, partly because there are scant communicated data in the medical literature.
The design of the proposed study involves performing one full colonoscopic examination (including ileoscopy) followed by one capsule endoscopy examination to the patients with SA. Prior to these examination, the patency of the gi tract will be tested using a patency capsule. If the patency of the gi tract is not confirmed, then the capsule endoscopy examination is abandoned.
Our aim is to explore about 100 patients in three years, thus having a close-to-reality "look" into the presence and extent of bowel involvement in the pool of the patients having SA; and also to characterize the lesions mainly depending on the treatment received, concomitant pathology and the form of the disease. We also aim to identify a relationship between the lesions found at colonoscopy and capsule endoscopy, the purpose being the possibility to predict one having only performed the other.
Thus, we hope to identify the therapeutic strategies that are most suited in the management of these patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spondyloarthropathies | – | Procedure: Capsule endoscopy examination, Procedure: ColonoscopyPatients with spondyloarthropathies (ankylosing spondylitis, reactive arthritis, psoriatic arthritis and spondylitis, enteropathic arthritis and spondylitis, juvenile-onset spondyloarthritis, and undifferentiated spondyloarthritis) as defined by the AMOR criteria |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with spondyloarthropathies (ankylosing spondylitis, reactive arthritis, psoriatic arthritis and spondylitis, enteropathic arthritis and spondylitis, juvenile-onset spondyloarthritis, and undifferentiated spondyloarthritis) reffered to a Universitary Clinic of Internal Medicine and Rheumatology
Key inclusion criteria (3 listed)
- signing of the inform consent
- subjects 18 years old or more
- patients with spondyloarthropathy as defined by the Amor criteria
Key exclusion criteria (7 listed)
- presumed intestinal obstruction
- impaired deglutition
- cardiac pace-makers present
- pregnancy
- pelvic or abdominal radiotherapy anytime in the past
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 |
|---|---|---|
| Capsule endoscopy examinationAlso: Given imaging capsule SB2Examination of the small bowel with endoscopic videocapsule | Procedure or surgery | Spondyloarthropathies |
| ColonoscopyAlso: Olympus Evis Exera II videocolonoscopeEndoscopic examination of the large bowel and terminal ileum | Procedure or surgery | Spondyloarthropathies |
Primary outcome
Number of patients with bowel lesions
Time frame: July 2012
1 secondary outcome
Correlation of the bowel lesions with patient status
Time frame: July 2012
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 14 Aug 2013.
- Background: PubMed 19886073Rimbas M, Marinescu M, Voiosu MR. Bowel lesions in spondyloarthritides. Rom J Intern Med. 2009;47(1):75-85.
- Results publication: PubMed 21448355Rimbas M, Marinescu M, Voiosu MR, Baicus CR, Caraiola S, Nicolau A, Nitescu D, Badea GC, Parvu MI. NSAID-induced deleterious effects on the proximal and mid small bowel in seronegative spondyloarthropathy patients. World J Gastroenterol. 2011 Feb 28;17(8):1030-5. doi: 10.3748/wjg.v17.i8.1030.
- Derived from this study: PubMed 28103201Chitul A, Voiosu AM, Marinescu M, Caraiola S, Nicolau A, Badea GC, Parvu MI, Ionescu RA, Mateescu BR, Voiosu MR, Baicus CR, Rimbas M. Different effects of anti-TNF-alpha biologic drugs on the small bowel macroscopic inflammation in patients with ankylosing spondylitis. Rom J Intern Med. 2017 Mar 1;55(1):44-52. doi: 10.1515/rjim-2017-0001.
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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.
Mihail R Voiosu, M.D., Ph.D. principal investigator
Carol Davila University of Medicine and Pharmacy
Mihai Rimbas, M.D. study chair
Carol Davila University of Medicine and Pharmacy
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 Spondyloarthropathies, run by Carol Davila University of Medicine and Pharmacy at 1 site in Romania.
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 3 inclusion and 7 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 14 Aug 2013. 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 Romania. 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?
Number of patients with bowel lesions (time frame: July 2012). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00768950, which also lists 3 linked publications.
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 14 Aug 2013.