NCT04999241Not yet recruitingPhase 4
Combined Application of EEN in the Induction of Remission in PUC
The Role of Combined Application of Exclusive Enteral Nutrition in the Induction of Remission for Children With Newly Diagnosed Moderate to Severe Ulcerative Colitis
Source: ClinicalTrials.gov · Last updated 3 Jul 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The role of exclusive enteral nutrition (EEN) in the induction of remission in pediatric patients with Crohn's disease had been well documented. But the role of EEN in children with Ulcerative Colitis (UC) was not clear. In this study, EEN will be combined with corticosteroids or infliximab in the induction of remission in pediatric UC patients with moderate to severe disease activity. The mucosal healing rate at week12 will be compared between the two groups (combine with EEN group VS non-combine group).
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 5 Aug 2021
- Start date
- 1 Mar 2025
- Primary completion date
- 1 Oct 2026
- Lead sponsor
- Children's Hospital of Fudan University
- Diseases
- Ulcerative colitis
- NCT number
- NCT04999241
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 40
- From 1 Mar 2025 to the primary completion date, 1 Oct 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Had been treated with corticosteroids or biologics
Other illness
- With mild disease activity at diagnosis
Who the study is looking for
- Newly diagnosed UC
- Years 6 to 18
- Moderate to severe disease activity at diagnosis
Age in the registry: 6 years to 18 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.