To assess the early predictive value of IUS for therapy response in children with IBD (new onset or known IBD).
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To assess the early predictive value of IUS at week 6 for therapy response
after 3 months in children with newly onset IBD starting therapy and children
with known IBD starting on remission induction therapy.
Secondary outcome
1. Predictive value of IUS at week 2 for treatment response at week 13.
2. To assess the difference in change of IUS parameters between different types
of remission induction therapy and types of IBD (CD versus UC).
3. Predictive value of transmural healing at week 13 as assessed by IUS for
remission at week 52.
Background summary
Choosing the right treatment for children with Inflammatory Bowel Disease (IBD)
in the early stages of disease is key to prevent disease progression and to
alter disease course. Intestinal Ultrasound (IUS) is a promising non-invasive
biomarker for IBD whose potential for early prediction of treatment response
has not been explored.
Study objective
To assess the early predictive value of IUS for therapy response in children
with IBD (new onset or known IBD).
Study design
Prospective observational study. Children with IBD starting on remission
induction therapy will undergo an IUS at baseline (T0). In those with visible
abnormalities, IUS will be repeated at 2 weeks (T1), 6 weeks (T2) and 13 weeks
(T3). Response to therapy will also be determined at T3
Study burden and risks
Ultrasound is a safe, fast and non-invasive way of imaging, hence the extent of
the burden of participating is limited. There will be no direct benefits of
participating. However, after completion of this study, patients might benefit
from the possibility to be monitored more accurately with a new non-invasive
biomarker which will help to predict the treatment response in an early stage.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Age 3-18y
Newly onset IBD or flare IBD
Starting new remission induction therapy
Exclusion criteria
No visible abnormalities on baseline IUS
Infectious gastroenteritis
Acute severe ulcerative colitis
Surgery as remission induction therapy
Previous intestinal surgery
Pregnancy
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL81827.018.22 |