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Combined Application of EEN in the Induction of Remission in PUC

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ClinicalTrials.gov Identifier: NCT04999241
Recruitment Status : Not yet recruiting
First Posted : August 10, 2021
Last Update Posted : August 2, 2022
Sponsor:
Information provided by (Responsible Party):
Ying HUANG, Children's Hospital of Fudan University

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).

Condition or disease Intervention/treatment Phase
Exclusive Enteral Nutrition Ulcerative Colitis Children Combination Product: exclusive enteral nutrition Combination Product: regular food Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : October 31, 2022
Estimated Primary Completion Date : October 1, 2024
Estimated Study Completion Date : December 31, 2026

Resource links provided by the National Library of Medicine

Drug Information available for: Infliximab

Arm Intervention/treatment
Experimental: EEN combined therapy group
in the induction of remission phase, EEN will be used combine with corticosteroids or infliximab
Combination Product: exclusive enteral nutrition
Administration of a liquid formula diet with the exclusion of all other regular food for 8 weeks, then patients can administration of regular food.
Other Name: corticosteroids, infliximab, 5-ASA, AZA

Active Comparator: Non EEN combination group
in the induction of remission phase, corticosteroids or infliximab will be used without EEN
Combination Product: regular food
Administration of regular food in the induction phase and the later time.
Other Name: corticosteroids, infliximab, 5-ASA, AZA




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. sustained corticosteroid-free clinical remission rate [ Time Frame: 1 year after intervention ]
    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.

  2. Treatment modification rate [ Time Frame: 1 year after intervention ]
    The rate of new treatment measures needed to be started due to worsening of symptoms.



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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04999241


Contacts
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Contact: Cui fang Zheng 8615221881022 zhengcuifang2@126.com

Sponsors and Collaborators
Children's Hospital of Fudan University
Investigators
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Study Director: Ying Huang Children's Hospital of Fudan University
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Responsible Party: Ying HUANG, Chief of Gastroenterology, Children's Hospital of Fudan University
ClinicalTrials.gov Identifier: NCT04999241    
Other Study ID Numbers: UC1.2
First Posted: August 10, 2021    Key Record Dates
Last Update Posted: August 2, 2022
Last Verified: April 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Mesalamine
Infliximab
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents