Inflammatory Bowel DiseaseNCT02003859
Predictive Value of pCLE Findings in Pediatric IBD
An observational study of Inflammatory Bowel Disease, run by Scientific Center of Children's Health RAMS at 1 site in Russia.
Trial summary
Studies over the past two decades have convincingly demonstrated the role of barrier dysfunction in the pathogenesis of inflammatory bowel disease. It previously shown that optical biopsy with probe-based confocal laser endomicroscopy (pCLE) could be used to assess mucosal barrier function. Read more about this study
- Who is it for?
- Ages 10 to 21 years
- Conditions the study is for
- Inflammatory Bowel Disease
- How many people
- 24 participants
- Where
- 1 siteRussia
- Study dates
- Nov 2010to Nov 2014
- 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 10 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric patients with IBD from all over Russia, treated from IBD in our Center
Who may be able to join
- signed informed consent
- patients with established IBD
Who cannot join
- Any kind of allergy
- Bronchial asthma
- Liver or kidney disease
- Inability to sign informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Studies over the past two decades have convincingly demonstrated the role of barrier dysfunction in the pathogenesis of inflammatory bowel disease. It previously shown that optical biopsy with probe-based confocal laser endomicroscopy (pCLE) could be used to assess mucosal barrier function. Furthermore, mucosal barrier dysfunction on pCLE was shown to be predictive of disease relapse in adult IBD patients. The purpose of the current study is to determine the predictive value of pCLE findings in pediatric IBD patients.
- Conditions
- Inflammatory Bowel Disease
- Keywords
- IBD, Pediatrics, pCLE
- Medical subject headings
- Inflammatory Bowel Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary study end-point was moderate to severe flare requiring hospitalization after pCLE
The purpose of the current study is to determine the predictive value of pCLE findings in pediatric IBD patients.
Measured: follow up period was a median of 18 months (range 4 to 33)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2013 (estimated)
- Study startNov 2010
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseaseStudies 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scientific Center of Children's Health RAMS
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alberta, Harvard Medical School (HMS and HSDM)
- Responsible party
- Principal investigator, Anton A. Shavrov, Scientific Center of Children's Health RAMS
- Investigators
- Andrey A Shavrov, M.D., Study chair, The Scientififc Center of Children's Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02003859
- Sponsor's protocol ID
- SCCH-001
- Status last verified
- Nov 2014
- First submitted
- 30 Nov 2013
- Last updated
- 19 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Shavrov A, Kharitonova AY, Davis EM, Claggett B, Morozov DA, Brown DK, Shavrov AA, Liu JJ. A Pilot Study of Confocal Laser Endomicroscopy to Predict Barrier Dysfunction and Relapse in Pediatric Inflammatory Bowel Disease. J Pediatr Gastroenterol Nutr. 2016 Jun;62(6):873-8. doi: 10.1097/MPG.0000000000001022.
PubMed 26513619
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of pCLE Findings in Pediatric IBD
- ClinicalTrials.gov ID
- NCT02003859
- Acronym / sponsor ID
- SCCH-001
- Conditions
- Inflammatory Bowel Disease
- Keywords
- IBD, Pediatrics, pCLE
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Scientific Center of Children's Health RAMSUniversity, hospital or other
- Collaborators
- University of Alberta, Harvard Medical School (HMS and HSDM)
- Study start
- Nov 2010
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 6 Dec 2013 (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.
Studies over the past two decades have convincingly demonstrated the role of barrier dysfunction in the pathogenesis of inflammatory bowel disease. It previously shown that optical biopsy with probe-based confocal laser endomicroscopy (pCLE) could be used to assess mucosal barrier function. Furthermore, mucosal barrier dysfunction on pCLE was shown to be predictive of disease relapse in adult IBD patients. The purpose of the current study is to determine the predictive value of pCLE findings in pediatric IBD patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 10 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric patients with IBD from all over Russia, treated from IBD in our Center
Key inclusion criteria (2 listed)
- signed informed consent
- patients with established IBD
Key exclusion criteria (4 listed)
- Any kind of allergy
- Bronchial asthma
- Liver or kidney disease
- Inability to sign informed consent
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
Primary study end-point was moderate to severe flare requiring hospitalization after pCLE
Time frame: follow up period was a median of 18 months (range 4 to 33)
The purpose of the current study is to determine the predictive value of pCLE findings in pediatric IBD patients.
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 Nov 2014.
- Derived from this study: PubMed 26513619Shavrov A, Kharitonova AY, Davis EM, Claggett B, Morozov DA, Brown DK, Shavrov AA, Liu JJ. A Pilot Study of Confocal Laser Endomicroscopy to Predict Barrier Dysfunction and Relapse in Pediatric Inflammatory Bowel Disease. J Pediatr Gastroenterol Nutr. 2016 Jun;62(6):873-8. doi: 10.1097/MPG.0000000000001022.
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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.
Andrey A Shavrov, M.D. study chair
The Scientififc Center of Children's Health
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 Disease, run by Scientific Center of Children's Health RAMS at 1 site in Russia.
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 4 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 Nov 2014. 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 Russia. 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?
Primary study end-point was moderate to severe flare requiring hospitalization after pCLE (time frame: follow up period was a median of 18 months (range 4 to 33)). 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 NCT02003859, which also lists 1 linked publication.
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 Nov 2014.