Acute Severe ColitisNCT06324500
Prognostic Role of Bowel Ultrasound Scan in Children Affected by Acute Severe Colitis
An observational study of Acute Severe Colitis, run by Meyer Children's Hospital IRCCS at 4 sites in 2 countries.
Trial summary
ASC is a life-threatening medical emergency. The lack of a timely intervention has shown to be associated with a mortality rate higher than 20% in adults, whereas a prompt targeted therapy has displayed a decrease of the aforementioned rate to 1%. Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Acute Severe Colitis
- How many people
- 120 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 2 Mar 2020to 2 May 2025
- 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 1 year to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients aged < 18 years hospitalized for ASC with diagnosis of UC established by the presence of accepted clinical, radiologic, endoscopic, and histologic criteria
Who may be able to join
- Patients aged < 18 years hospitalized for ASC with diagnosis of UC established by the presence of accepted clinical, radiologic, endoscopic, and histologic criteria
Who cannot join
- Patients with infectious colitis;
- Patients undergoing treatment with anti-TNF alpha agents;
- Patients already enrolled during the study period for a previous ASC attack;
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Italy3 sites, 3 recruiting
- Recruiting
Ospedale Maggiore
Bologna
Patrizia Alvisi, Patrizia.alvisi@ausl.bologna.it
- Recruiting
Meyer Children's Hospital IRCCS
Florence, Firenze, 50139
Paolo Lionetti, paolo.lionetti@meyer.it
- Recruiting
IRCCS Materno Infantile Burlo Garofolo
Trieste
Matteo Bramuzzo, matteo.bramuzzo@burlo.trieste.it
Spain1 site, 1 recruiting
- Recruiting
CMED Centro Médico-Quirúrgico de Enfermedades Digestivas
Madrid
Marta Velasco Rodriguez- Belvis, martavrb@gmail.com
About this study
Official title: Prognostic Role of Bowel Ultrasound Scan in Children Affected by Acute Severe Colitis (ASC): A Prospective Multicenter Study From the Paediatric IBD Porto Group of ESPGHAN
ASC is a life-threatening medical emergency. The lack of a timely intervention has shown to be associated with a mortality rate higher than 20% in adults, whereas a prompt targeted therapy has displayed a decrease of the aforementioned rate to 1%. Therefore, the identification of predictors of poor outcome trough an objective tool may provide crucial help to individualize the timing of second line treatment initiation. At the state of the art, PUCAI represents the only validated tool to appraise the risk of first-line treatment failure and there is a lack of objective methods with a prognostic value in ASC.
BUS has proven to be a reliable tool in assessing disease activity in children with UC and it has also shown statistically significant correlation with endoscopic features of disease activity. Given the literature suggesting a role for BUS in severe UC and the results from our retrospective study we aim to validate our findings trough a prospective assessment of the potential prognostic role of BUS in ASC.
- Conditions
- Acute Severe Colitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Colonic wall thickness of BUS (bowel ultrasound) parameter to predict the failure of first line treatment
Investigation of the ability of BUS (bowel ultrasound) parameters, such as Colonic wall thickness (CWT) measured in mm, assessed within 48 hours from i.v. steroid treatment initiation, to predict the failure of first line treatment (defined according to the latest ESPGHAN guidelines).
CWT will be measured from the edge of the outer wall to the inner echogenic lumen, containing air, or to the central echogenic mucosal stripe. CWT will be assessed as follows: two measurement through longitudinal plain and two through tranverse plain will be performed and the mean value (the sum of each measurement divided for 4) will be taken into account
Measured: Within 48 hours from i.v. steroid treatment initiation
Color and power Doppler vascularization of BUS (bowel ultrasound) parameter to predict the failure of first line treatment
Colonic wall vascularization will be assessed according to the Limberg score to identify two subgroups: 1) increased vascularization (Limberg score 3-4); 2) normal colonic wall flow (Limberg Score 0-2). Such classification will be used, measured within the first 48 hours from i.v. steroid initiation, to predict failure of first line treatment (according to the latest ESPGHAN guidelines)
Measured: Within 48 hours from i.v. steroid treatment initiation
Mesenteric lymph nodes BUS (bowel ultrasound) parameter
Presence of enlarged mesenteric lymph nodes, defined by short axis > 5 mm it will be assessed within 48 hours from i.v. steroid treatment initiation, to predict the failure of first line treatment (defined according to the latest ESPGHAN guidelines)
Measured: Within 48 hours from i.v. steroid treatment initiation
Secondary outcomes (1)
evaluation of the prognostic value of the ultrasound parameters
evaluation of the prognostic value of the ultrasound parameters in predicting the possible failure of second-line therapy and therefore the need to carry out colectomy surgery
Measured: Within 48 hours from second-line therapy initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start2 Mar 2020
- Primary completion2 Mar 2025 (estimated)
- Study completion2 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Severe ColitisStudies of the same condition, open and under way.
- More trials run by Meyer Children's Hospital IRCCSThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meyer Children's Hospital IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paolo Lionetti, Meyer Children's Hospital IRCCS
- Investigators
- Paolo Lionetti, MD, Principal investigator, Meyer Children's Hospital IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06324500
- Sponsor's protocol ID
- ASC-US
- Status last verified
- Mar 2024
- First submitted
- 23 Feb 2024
- Last updated
- 22 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Role of Bowel Ultrasound Scan in Children Affected by Acute Severe Colitis (ASC): A Prospective Multicenter Study From the Paediatric IBD Porto Group of ESPGHAN
- ClinicalTrials.gov ID
- NCT06324500
- Acronym / sponsor ID
- ASC-US
- Conditions
- Acute Severe Colitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Meyer Children's Hospital IRCCSUniversity, hospital or other
- Study start
- 2 Mar 2020 (actual)
- Primary completion
- 2 Mar 2025 (estimated)
- Study completion
- 2 May 2025 (estimated)
- First posted
- 22 Mar 2024 (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.
ASC is a life-threatening medical emergency. The lack of a timely intervention has shown to be associated with a mortality rate higher than 20% in adults, whereas a prompt targeted therapy has displayed a decrease of the aforementioned rate to 1%. Therefore, the identification of predictors of poor outcome trough an objective tool may provide crucial help to individualize the timing of second line treatment initiation. At the state of the art, PUCAI represents the only validated tool to appraise the risk of first-line treatment failure and there is a lack of objective methods with a prognostic value in ASC.
BUS has proven to be a reliable tool in assessing disease activity in children with UC and it has also shown statistically significant correlation with endoscopic features of disease activity. Given the literature suggesting a role for BUS in severe UC and the results from our retrospective study we aim to validate our findings trough a prospective assessment of the potential prognostic role of BUS in ASC.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients aged < 18 years hospitalized for ASC with diagnosis of UC established by the presence of accepted clinical, radiologic, endoscopic, and histologic criteria
Key inclusion criteria (1 listed)
- Patients aged < 18 years hospitalized for ASC with diagnosis of UC established by the presence of accepted clinical, radiologic, endoscopic, and histologic criteria
Key exclusion criteria (3 listed)
- Patients with infectious colitis;
- Patients undergoing treatment with anti-TNF alpha agents;
- Patients already enrolled during the study period for a previous ASC attack;
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
Colonic wall thickness of BUS (bowel ultrasound) parameter to predict the failure of first line treatment
Time frame: Within 48 hours from i.v. steroid treatment initiation
Investigation of the ability of BUS (bowel ultrasound) parameters, such as Colonic wall thickness (CWT) measured in mm, assessed within 48 hours from i.v. steroid treatment initiation, to predict the failure of first line treatment (defined according to the latest ESPGHAN guidelines). CWT will be measured from the edge of the outer wall to the inner echogenic lumen, containing air, or to the central echogenic mucosal stripe. CWT will be assessed as follows: two measurement through longitudinal plain and two through tranverse plain will be performed and the mean value (the sum of each measurement divided for 4) will be taken into account
Color and power Doppler vascularization of BUS (bowel ultrasound) parameter to predict the failure of first line treatment
Time frame: Within 48 hours from i.v. steroid treatment initiation
Colonic wall vascularization will be assessed according to the Limberg score to identify two subgroups: 1) increased vascularization (Limberg score 3-4); 2) normal colonic wall flow (Limberg Score 0-2). Such classification will be used, measured within the first 48 hours from i.v. steroid initiation, to predict failure of first line treatment (according to the latest ESPGHAN guidelines)
Mesenteric lymph nodes BUS (bowel ultrasound) parameter
Time frame: Within 48 hours from i.v. steroid treatment initiation
Presence of enlarged mesenteric lymph nodes, defined by short axis > 5 mm it will be assessed within 48 hours from i.v. steroid treatment initiation, to predict the failure of first line treatment (defined according to the latest ESPGHAN guidelines)
1 secondary outcome
evaluation of the prognostic value of the ultrasound parameters
Time frame: Within 48 hours from second-line therapy initiation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- 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.
Paolo Lionetti, MD principal investigator
Meyer Children's Hospital IRCCS
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Severe Colitis, run by Meyer Children's Hospital IRCCS at 4 sites in 2 countries.
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 3 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: status not confirmed, as of the sponsor's last update on 22 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy, Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paolo Lionetti (3398416059, paolo.lionetti@meyer.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Colonic wall thickness of BUS (bowel ultrasound) parameter to predict the failure of first line treatment (time frame: Within 48 hours from i.v. steroid treatment initiation). The study lists 3 primary outcomes in all. 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 22 Mar 2024.