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Early prediction of treatment response in children with Inflammatory Bowel Disease with Intestinal Ultrasound

Early prediction of treatment response in children with Inflammatory Bowel Disease with Intestinal Ultrasound - RAINBOW-3

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON51551
Enrollment
120
Registered
2022-09-12
Start date
2022-11-17
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic inflammation of the bowel Inflammatory Bowel Disease

Interventions

None listed

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
2 Years to 64 Years

Inclusion criteria

Inclusion criteria: Age 3-18y Newly onset IBD or flare IBD Starting new remission induction therapy

Exclusion criteria

Exclusion criteria: No visible abnormalities on baseline IUS Infectious gastroenteritis Acute severe ulcerative colitis Surgery as remission induction therapy Previous intestinal surgery Pregnancy

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)