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Combined Application of EEN in the Induction of Remission in PUC

Primary Purpose

Exclusive Enteral Nutrition, Ulcerative Colitis, Children

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
exclusive enteral nutrition
regular food
Sponsored by
Children's Hospital of Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Exclusive Enteral Nutrition

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    EEN combined therapy group

    Non EEN combination group

    Arm Description

    in the induction of remission phase, EEN will be used combine with corticosteroids or infliximab

    in the induction of remission phase, corticosteroids or infliximab will be used without EEN

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    Treatment modification rate
    The rate of new treatment measures needed to be started due to worsening of symptoms.

    Full Information

    First Posted
    August 5, 2021
    Last Updated
    July 3, 2023
    Sponsor
    Children's Hospital of Fudan University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04999241
    Brief Title
    Combined Application of EEN in the Induction of Remission in PUC
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 1, 2024 (Anticipated)
    Primary Completion Date
    October 1, 2024 (Anticipated)
    Study Completion Date
    December 31, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Children's Hospital of Fudan University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Exclusive Enteral Nutrition, Ulcerative Colitis, Children

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    EEN combined therapy group
    Arm Type
    Experimental
    Arm Description
    in the induction of remission phase, EEN will be used combine with corticosteroids or infliximab
    Arm Title
    Non EEN combination group
    Arm Type
    Active Comparator
    Arm Description
    in the induction of remission phase, corticosteroids or infliximab will be used without EEN
    Intervention Type
    Combination Product
    Intervention Name(s)
    exclusive enteral nutrition
    Other Intervention Name(s)
    corticosteroids, infliximab, 5-ASA, AZA
    Intervention Description
    Administration of a liquid formula diet with the exclusion of all other regular food for 8 weeks, then patients can administration of regular food.
    Intervention Type
    Combination Product
    Intervention Name(s)
    regular food
    Other Intervention Name(s)
    corticosteroids, infliximab, 5-ASA, AZA
    Intervention Description
    Administration of regular food in the induction phase and the later time.
    Primary Outcome Measure Information:
    Title
    The mucosal healing rate
    Description
    The Ulcerative Colitis Endoscopic Index of Severity (UCEIS) ≦1 points is defined as mucosal healing. This will be evaluated by inflammatory bowel disease endoscopist.
    Time Frame
    12 week after intervention
    Secondary Outcome Measure Information:
    Title
    sustained corticosteroid-free clinical remission rate
    Description
    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.
    Time Frame
    1 year after intervention
    Title
    Treatment modification rate
    Description
    The rate of new treatment measures needed to be started due to worsening of symptoms.
    Time Frame
    1 year after intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Newly diagnosed UC Years 6 to 18 Moderate to severe disease activity at diagnosis Exclusion Criteria: With mild disease activity at diagnosis Had been treated with corticosteroids or biologics
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Cui fang Zheng
    Phone
    8615221881022
    Email
    zhengcuifang2@126.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ying Huang
    Organizational Affiliation
    Children's Hospital of Fudan University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Combined Application of EEN in the Induction of Remission in PUC

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