Combined Application of EEN in the Induction of Remission in PUC
Phase 4 · Testing exclusive enteral nutrition and regular food · Sites not listed yet · Children's Hospital of Fudan University
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing exclusive enteral nutrition (a combination product) and regular food (a combination product) as a possible treatment. Condition(s) listed: Exclusive Enteral Nutrition, Ulcerative Colitis and Children.
Participants are assigned to groups by chance (randomized).
It is single-blind: participants do not know which group they are in.
Phase 4 studies look at treatments that are already approved, to learn more about how they work in everyday use.
Who can join
- Ages 6 to 18
- Any sex
Some of the main requirements, copied from the record:
- Newly diagnosed UC
- Years 6 to 18
- Moderate to severe disease activity at diagnosis
There are also 2 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 40 participants are expected to take part.
- Start date: 2025-03-01 (planned).
- Main results expected around 2026-10-01 (estimate from the record).
- No study sites are listed yet. Check the official record for contact details.
Main thing being measured
- The mucosal healing rate (12 week after intervention)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Phase 4 |
| Study type | Interventional |
| Conditions | Exclusive Enteral Nutrition; Ulcerative Colitis; Children |
| Lead sponsor | Children's Hospital of Fudan University |
| Enrollment | 40 (estimated) |
| Start date | 2025-03-01 |
| Primary completion (est.) | 2026-10-01 |
| First posted | 2021-08-10 |
| Last updated | 2024-07-03 |
| Official title | The Role of Combined Application of Exclusive Enteral Nutrition in the Induction of Remission for Children With Newly Diagnosed Moderate to Severe Ulcerative Colitis |
| ClinicalTrials.gov ID | NCT04999241 |
Interventions
- exclusive enteral nutrition (Combination Product)
Administration of a liquid formula diet with the exclusion of all other regular food for 8 weeks, then patients can administration of regular food. - regular food (Combination Product)
Administration of regular food in the induction phase and the later time.
Full eligibility criteria (from the record)
Inclusion Criteria: 1. Newly diagnosed UC 2. Years 6 to 18 3. Moderate to severe disease activity at diagnosis Exclusion Criteria: 1. With mild disease activity at diagnosis 2. Had been treated with corticosteroids or biologics
Locations (0)
No sites listed yet. The official record has contact information.
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.