Inflammatory Bowel DiseasesPCENCT03161886
A Treat-to-target Strategy Using Pan-enteric Capsule Endoscopy (PCE) in Paediatric Crohn's Disease (CD).
A study testing Pan-enteric Capsule Endoscopy (PCE) in people with Inflammatory Bowel Diseases and Children, Only, run by Azienda Policlinico Umberto I.
Trial summary
This prospective, interventional study aims this to determine the efficacy and safety of a PCE-based treat-to-target strategy in order to achieve Mucosal Healing (MH) and deep remission (DR) of pediatric Crohn's Disease (CD) over 52 weeks. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Inflammatory Bowel Diseases, Children, Only
- What is being tested?
- Pan-enteric Capsule Endoscopy (PCE)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2014to 10 Jan 2017
- Phase
- Interventional
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- diagnosis of Crohn's Disease made at least 3 months before the enrolment;
- subject was referred for endoscopic and imaging follow-up in Crohn's Disease
- signed informed consent.
Who cannot join
- Subject has dysphagia
- Subject has renal insufficiency
- Subject is known structuring Crohn's Disease identified by magnetic resonance enterography (MRE) or small intestine contrast ultrasonography (SICUS).
- Subject has had prior abdominal surgery of the gastrointestinal tract other than uncomplicated procedures that would be unlikely to lead to bowel obstruction based on the magnetic resonance enterography findings and clinical judgment of the investigator.
About this study
Official title: A Treat-to-target Strategy Using Pan-enterica Capsule Endoscopy (PCE) in Paediatric Crohn's Disease (CD).
This prospective, interventional study aims this to determine the efficacy and safety of a PCE-based treat-to-target strategy in order to achieve Mucosal Healing (MH) and deep remission (DR) of pediatric Crohn's Disease (CD) over 52 weeks.
Read the detailed description
This first prospective study on mucosal healing (MH) and deep remission (DR) in pediatric Crohn's Disease aims to evaluate:
- The ability of Pan-enteric capsule endoscopy (PCE) to assess MH and DR rates at three time points and to guide a treat-to-target strategy was the primary outcome sought.
- The efficacy of a "treat-to-target" strategy to MH and DR rates over 24 and 52 weeks was evaluated as a secondary outcome;
- Comparison between PCE, biomarkers, Magnetic Resonance Enterography (MRE) and Small Intestine contrast ultrasonography (SICUS) in evaluating intestinal inflammation.
- Conditions
- Inflammatory Bowel Diseases, Children, Only
- Being tested
- Pan-enteric Capsule Endoscopy (PCE)
- Keywords
- colon capsule endoscopy
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pan-enteric Capsule Endoscopy (PCE)Device
Second generation of colon capsule endoscopy (Medtronic)
| Study group | Role | What they receive |
|---|---|---|
| Pan-enteric capsule endoscopy (PCE) | Experimental | Evidence of active disease by PCE prompted a change in therapy at the discretion of the treating clinician and according to current available pediatric guidelines. The definition of medical treatment adjustment after evidence of inflammation was: the introduction of steroids or enteral nutrition, the introduction or optimization of immunosuppressives; the introduction, optimization of biologics; or the introduction of both immunosuppressive agents and biologics. In case of a negative PCE and presence of symptoms, the magnetic resonance enterography (MRE) could help in guiding therapeutic decisions. Receives: Device: Pan-enteric Capsule Endoscopy (PCE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monitoring mucosal healing
-The ability of PCE to assess mucosal healing rate (percentage of patients with healing of the mucosa) at three time points and to guide a treat-to-target strategy was the primary outcome sought.
and colonic CD
Measured: 52 weeks
Monitoring deep remission
-The ability of PCE to assess deep remission rate (percentage of patients with healing of the mucosa and absence of symptoms) at three time points and to guide a treat-to-target strategy was the primary outcome sought.
and colonic CD
Measured: 52 weeks
Secondary outcomes (2)
Treat to Target
-The efficacy of a "treat-to-target" strategy to increase percentage of patients with mucosal healing (healing of the mucosa) and deep remission (healing of the mucosa and absence of symptoms) rates over 24 and 52 weeks
Measured: 52 weeks
Diagnostic Yield
percentage of patients with positive finding at PCE, biomarkers, Magnetic Resonance Enterography (MRE) and Small Intestine contrast ultrasonography (SICUS).
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2017
- Study start1 Dec 2014
- Primary completion1 Dec 2016
- Study completion10 Jan 2017
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 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Policlinico Umberto I
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salvatore Oliva, Azienda Policlinico Umberto I
- Investigators
- Salvatore Oliva, MD, Principal investigator, Sapienza - University of Rome, Azienda Policlinico Umberto I
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03161886
- Sponsor's protocol ID
- PCE Monitoring CD
- Acronym
- PCE
- Status last verified
- Jan 2018
- First submitted
- 19 May 2017
- Last updated
- 8 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Oliva S, Cucchiara S, Civitelli F, Casciani E, Di Nardo G, Hassan C, Papoff P, Cohen SA. Colon capsule endoscopy compared with other modalities in the evaluation of pediatric Crohn's disease of the small bowel and colon. Gastrointest Endosc. 2016 May;83(5):975-83. doi: 10.1016/j.gie.2015.08.070. Epub 2015 Sep 9.
PubMed 26363334D'Arcangelo G, Russo G, Aloi M, Ruggiero C, Maccioni F, Hassan C, Papoff P, Cohen SA, Oliva S. A Treat-to-Target Strategy Guided by Pan-Enteric Evaluation in Children With Crohn's Disease Improves Outcomes at 2 Years. Inflamm Bowel Dis. 2024 Aug 1;30(8):1303-1308. doi: 10.1093/ibd/izad173.
PubMed 37603835Oliva S, Aloi M, Viola F, Mallardo S, Civitelli F, Maccioni F, Hassan C, Papoff P, Cucchiara S, Cohen SA. A Treat to Target Strategy Using Panenteric Capsule Endoscopy in Pediatric Patients With Crohn's Disease. Clin Gastroenterol Hepatol. 2019 Sep;17(10):2060-2067.e1. doi: 10.1016/j.cgh.2018.10.015. Epub 2018 Oct 13.
PubMed 30326301
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Treat-to-target Strategy Using Pan-enterica Capsule Endoscopy (PCE) in Paediatric Crohn's Disease (CD).
- ClinicalTrials.gov ID
- NCT03161886
- Acronym / sponsor ID
- PCE / PCE Monitoring CD
- Conditions
- Inflammatory Bowel Diseases, Children, Only
- Keywords
- colon capsule endoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Azienda Policlinico Umberto IUniversity, hospital or other
- Study start
- 1 Dec 2014 (actual)
- Primary completion
- 1 Dec 2016 (actual)
- Study completion
- 10 Jan 2017 (actual)
- First posted
- 22 May 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.
This prospective, interventional study aims this to determine the efficacy and safety of a PCE-based treat-to-target strategy in order to achieve Mucosal Healing (MH) and deep remission (DR) of pediatric Crohn's Disease (CD) over 52 weeks.
Detailed description
This first prospective study on mucosal healing (MH) and deep remission (DR) in pediatric Crohn's Disease aims to evaluate:
- The ability of Pan-enteric capsule endoscopy (PCE) to assess MH and DR rates at three time points and to guide a treat-to-target strategy was the primary outcome sought.
- The efficacy of a "treat-to-target" strategy to MH and DR rates over 24 and 52 weeks was evaluated as a secondary outcome;
- Comparison between PCE, biomarkers, Magnetic Resonance Enterography (MRE) and Small Intestine contrast ultrasonography (SICUS) in evaluating intestinal inflammation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pan-enteric capsule endoscopy (PCE) | Experimental | Device: Pan-enteric Capsule Endoscopy (PCE)Evidence of active disease by PCE prompted a change in therapy at the discretion of the treating clinician and according to current available pediatric guidelines. The definition of medical treatment adjustment after evidence of inflammation was: the introduction of steroids or enteral nutrition, the introduction or optimization of immunosuppressives; the introduction, optimization of biologics; or the introduction of both immunosuppressive agents and biologics. In case of a negative PCE and presence of symptoms, the magnetic resonance enterography (MRE) could help in guiding therapeutic decisions. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- diagnosis of Crohn's Disease made at least 3 months before the enrolment;
- subject was referred for endoscopic and imaging follow-up in Crohn's Disease
- signed informed consent.
Key exclusion criteria (4 listed)
- Subject has dysphagia
- Subject has renal insufficiency
- Subject is known structuring Crohn's Disease identified by magnetic resonance enterography (MRE) or small intestine contrast ultrasonography (SICUS).
- Subject has had prior abdominal surgery of the gastrointestinal tract other than uncomplicated procedures that would be unlikely to lead to bowel obstruction based on the magnetic resonance enterography findings and clinical judgment of the investigator.
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 |
|---|---|---|
| Pan-enteric Capsule Endoscopy (PCE)Second generation of colon capsule endoscopy (Medtronic) | Device | Pan-enteric capsule endoscopy (PCE) |
Primary outcome
Monitoring mucosal healing
Time frame: 52 weeks
-The ability of PCE to assess mucosal healing rate (percentage of patients with healing of the mucosa) at three time points and to guide a treat-to-target strategy was the primary outcome sought. and colonic CD
Monitoring deep remission
Time frame: 52 weeks
-The ability of PCE to assess deep remission rate (percentage of patients with healing of the mucosa and absence of symptoms) at three time points and to guide a treat-to-target strategy was the primary outcome sought. and colonic CD
2 secondary outcomes
Treat to Target
Time frame: 52 weeks
Diagnostic Yield
Time frame: 52 weeks
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 8 Jan 2018.
- Results publication: PubMed 26363334Oliva S, Cucchiara S, Civitelli F, Casciani E, Di Nardo G, Hassan C, Papoff P, Cohen SA. Colon capsule endoscopy compared with other modalities in the evaluation of pediatric Crohn's disease of the small bowel and colon. Gastrointest Endosc. 2016 May;83(5):975-83. doi: 10.1016/j.gie.2015.08.070. Epub 2015 Sep 9.
- Derived from this study: PubMed 37603835D'Arcangelo G, Russo G, Aloi M, Ruggiero C, Maccioni F, Hassan C, Papoff P, Cohen SA, Oliva S. A Treat-to-Target Strategy Guided by Pan-Enteric Evaluation in Children With Crohn's Disease Improves Outcomes at 2 Years. Inflamm Bowel Dis. 2024 Aug 1;30(8):1303-1308. doi: 10.1093/ibd/izad173.
- Derived from this study: PubMed 30326301Oliva S, Aloi M, Viola F, Mallardo S, Civitelli F, Maccioni F, Hassan C, Papoff P, Cucchiara S, Cohen SA. A Treat to Target Strategy Using Panenteric Capsule Endoscopy in Pediatric Patients With Crohn's Disease. Clin Gastroenterol Hepatol. 2019 Sep;17(10):2060-2067.e1. doi: 10.1016/j.cgh.2018.10.015. Epub 2018 Oct 13.
- Individual participant dataSharing planned: No
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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.
Salvatore Oliva, MD principal investigator
Sapienza - University of Rome, Azienda Policlinico Umberto I
Questions about this trial
What is this clinical trial studying?
A study testing Pan-enteric Capsule Endoscopy (PCE) in people with Inflammatory Bowel Diseases and Children, Only, run by Azienda Policlinico Umberto I.
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 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 8 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Monitoring mucosal healing (time frame: 52 weeks). The study lists 2 primary outcomes in all. 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 NCT03161886, 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 8 Jan 2018.