Exclusive Enteral NutritionPhase 4NCT04999241
Combined Application of EEN in the Induction of Remission in PUC
A Phase 4 study testing exclusive enteral nutrition and regular food in people with Exclusive Enteral Nutrition and Ulcerative Colitis, run by Children's Hospital of Fudan University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Exclusive Enteral Nutrition, Ulcerative Colitis, Children
- What is being tested?
- exclusive enteral nutrition and regular food
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2025to 31 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Newly diagnosed UC
- Years 6 to 18
- Moderate to severe disease activity at diagnosis
Who cannot join
- With mild disease activity at diagnosis
- Had been treated with corticosteroids or biologics
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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).
Read the detailed description
The role of exclusive enteral nutrition (EEN) in the induction of remission in pediatric patients with Crohn's disease(CD) had been well documented. Several randomized controlled trial studies found that the overall induction of remission was equipotent with EEN compared to corticosteroids for pediatric CD. However, in promoting mucosal healing and improving the nutritional status, EEN was much better than corticosteroids. 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 week 12 will be compared between the two groups (combine with EEN group VS non-combine group).The sustained corticosteroid-free clinical remission rate and treatment modification rate during the first year will also be evaluated.
- Conditions
- Exclusive Enteral Nutrition, Ulcerative Colitis, Children
- Being tested
- exclusive enteral nutrition, regular food
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exclusive enteral nutritionCombination product
Also called corticosteroids, infliximab, 5-ASA, AZA
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 foodCombination product
Also called corticosteroids, infliximab, 5-ASA, AZA
Administration of regular food in the induction phase and the later time.
| Study group | Role | What they receive |
|---|---|---|
| EEN combined therapy group | Experimental | in the induction of remission phase, EEN will be used combine with corticosteroids or infliximab Receives: Combination Product: exclusive enteral nutrition |
| Non EEN combination group | Active comparator | in the induction of remission phase, corticosteroids or infliximab will be used without EEN Receives: Combination Product: regular food |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mucosal healing rate
The Ulcerative Colitis Endoscopic Index of Severity (UCEIS) ≦1 points is defined as mucosal healing. This will be evaluated by inflammatory bowel disease endoscopist.
Measured: 12 week after intervention
Secondary outcomes (2)
sustained corticosteroid-free clinical remission rate
Sustained pediatric Ulcerative Colitis activity index (PUCAI) score <10 points during follow-up (week 14 to week 54 after intervention) without the treatment of corticosteroids . This will be evaluated by gastroenterologist.
Measured: 1 year after intervention
Treatment modification rate
The rate of new treatment measures needed to be started due to worsening of symptoms.
Measured: 1 year after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2021
- Study start1 Mar 2025 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exclusive Enteral NutritionStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ying HUANG, Children's Hospital of Fudan University
- Investigators
- Ying Huang, Study director, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04999241
- Sponsor's protocol ID
- UC1.2
- Status last verified
- Jul 2024
- First submitted
- 5 Aug 2021
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- UC1.2
- Conditions
- Exclusive Enteral Nutrition, Ulcerative Colitis, Children
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 10 Aug 2021 (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.
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).
Detailed description
The role of exclusive enteral nutrition (EEN) in the induction of remission in pediatric patients with Crohn's disease(CD) had been well documented. Several randomized controlled trial studies found that the overall induction of remission was equipotent with EEN compared to corticosteroids for pediatric CD. However, in promoting mucosal healing and improving the nutritional status, EEN was much better than corticosteroids. 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 week 12 will be compared between the two groups (combine with EEN group VS non-combine group).The sustained corticosteroid-free clinical remission rate and treatment modification rate during the first year will also be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EEN combined therapy group | Experimental | Combination Product: exclusive enteral nutritionin the induction of remission phase, EEN will be used combine with corticosteroids or infliximab |
| Non EEN combination group | Active comparator | Combination Product: regular foodin the induction of remission phase, corticosteroids or infliximab will be used without EEN |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Newly diagnosed UC
- Years 6 to 18
- Moderate to severe disease activity at diagnosis
Key exclusion criteria (2 listed)
- With mild disease activity at diagnosis
- Had been treated with corticosteroids or biologics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exclusive enteral nutritionAlso: corticosteroids, infliximab, 5-ASA, AZAAdministration of a liquid formula diet with the exclusion of all other regular food for 8 weeks, then patients can administration of regular food. | Combination product | EEN combined therapy group |
| regular foodAlso: corticosteroids, infliximab, 5-ASA, AZAAdministration of regular food in the induction phase and the later time. | Combination product | Non EEN combination group |
Primary outcome
The mucosal healing rate
Time frame: 12 week after intervention
The Ulcerative Colitis Endoscopic Index of Severity (UCEIS) ≦1 points is defined as mucosal healing. This will be evaluated by inflammatory bowel disease endoscopist.
2 secondary outcomes
sustained corticosteroid-free clinical remission rate
Time frame: 1 year after intervention
Treatment modification rate
Time frame: 1 year after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
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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.
Ying Huang study director
Children's Hospital of Fudan University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing exclusive enteral nutrition and regular food in people with Exclusive Enteral Nutrition and Ulcerative Colitis, run by Children's Hospital of Fudan University.
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 3 inclusion and 2 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: opening soon, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cui fang Zheng (8615221881022, zhengcuifang2@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The mucosal healing rate (time frame: 12 week after intervention). 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 3 Jul 2024.