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Combined Application of EEN in the Induction of Remission in PUC

Studies

Study First Submitted Date 2021-08-05
Study First Posted Date 2021-08-10
Last Update Posted Date 2023-07-05
Start Month Year March 1, 2024
Primary Completion Month Year October 1, 2024
Verification Month Year July 2023
Verification Date 2023-07-31
Last Update Posted Date 2023-07-05

Detailed Descriptions

Sequence: 20712263
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.

Browse Interventions

Sequence: 96007687 Sequence: 96007688 Sequence: 96007689 Sequence: 96007690 Sequence: 96007691 Sequence: 96007692 Sequence: 96007693 Sequence: 96007694 Sequence: 96007695 Sequence: 96007696 Sequence: 96007697 Sequence: 96007698 Sequence: 96007699
Mesh Term Infliximab Mesh Term Mesalamine Mesh Term Tumor Necrosis Factor Inhibitors Mesh Term Anti-Inflammatory Agents Mesh Term Dermatologic Agents Mesh Term Gastrointestinal Agents Mesh Term Antirheumatic Agents Mesh Term Anti-Inflammatory Agents, Non-Steroidal Mesh Term Analgesics, Non-Narcotic Mesh Term Analgesics Mesh Term Sensory System Agents Mesh Term Peripheral Nervous System Agents Mesh Term Physiological Effects of Drugs
Downcase Mesh Term infliximab Downcase Mesh Term mesalamine Downcase Mesh Term tumor necrosis factor inhibitors Downcase Mesh Term anti-inflammatory agents Downcase Mesh Term dermatologic agents Downcase Mesh Term gastrointestinal agents Downcase Mesh Term antirheumatic agents Downcase Mesh Term anti-inflammatory agents, non-steroidal Downcase Mesh Term analgesics, non-narcotic Downcase Mesh Term analgesics Downcase Mesh Term sensory system agents Downcase Mesh Term peripheral nervous system agents Downcase Mesh Term physiological effects of drugs
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Conditions

Sequence: 52145132 Sequence: 52145133 Sequence: 52145134
Name Exclusive Enteral Nutrition Name Ulcerative Colitis Name Children
Downcase Name exclusive enteral nutrition Downcase Name ulcerative colitis Downcase Name children

Id Information

Sequence: 40139508
Id Source org_study_id
Id Value UC1.2

Design Groups

Sequence: 55566026 Sequence: 55566027
Group Type Experimental Group Type Active Comparator
Title EEN combined therapy group Title Non EEN combination group
Description in the induction of remission phase, EEN will be used combine with corticosteroids or infliximab Description in the induction of remission phase, corticosteroids or infliximab will be used without EEN

Interventions

Sequence: 52460986 Sequence: 52460987
Intervention Type Combination Product Intervention Type Combination Product
Name exclusive enteral nutrition Name regular food
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. Description Administration of regular food in the induction phase and the later time.

Design Outcomes

Sequence: 177289172 Sequence: 177289173 Sequence: 177289174
Outcome Type primary Outcome Type secondary Outcome Type secondary
Measure The mucosal healing rate Measure sustained corticosteroid-free clinical remission rate Measure Treatment modification rate
Time Frame 12 week after intervention Time Frame 1 year after intervention Time Frame 1 year after intervention
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. 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. Description The rate of new treatment measures needed to be started due to worsening of symptoms.

Browse Conditions

Sequence: 193389562 Sequence: 193389563 Sequence: 193389564 Sequence: 193389565 Sequence: 193389566 Sequence: 193389567 Sequence: 193389568 Sequence: 193389569 Sequence: 193389570 Sequence: 193389571
Mesh Term Colitis Mesh Term Colitis, Ulcerative Mesh Term Ulcer Mesh Term Gastroenteritis Mesh Term Gastrointestinal Diseases Mesh Term Digestive System Diseases Mesh Term Colonic Diseases Mesh Term Intestinal Diseases Mesh Term Pathologic Processes Mesh Term Inflammatory Bowel Diseases
Downcase Mesh Term colitis Downcase Mesh Term colitis, ulcerative Downcase Mesh Term ulcer Downcase Mesh Term gastroenteritis Downcase Mesh Term gastrointestinal diseases Downcase Mesh Term digestive system diseases Downcase Mesh Term colonic diseases Downcase Mesh Term intestinal diseases Downcase Mesh Term pathologic processes Downcase Mesh Term inflammatory bowel diseases
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48296118
Agency Class OTHER
Lead Or Collaborator lead
Name Children's Hospital of Fudan University

Overall Officials

Sequence: 29271611
Role Study Director
Name Ying Huang
Affiliation Children's Hospital of Fudan University

Central Contacts

Sequence: 12002513
Contact Type primary
Name Cui fang Zheng
Phone 8615221881022
Email zhengcuifang2@126.com
Role Contact

Design Group Interventions

Sequence: 68115950 Sequence: 68115951
Design Group Id 55566026 Design Group Id 55566027
Intervention Id 52460986 Intervention Id 52460987

Eligibilities

Sequence: 30751120
Gender All
Minimum Age 6 Years
Maximum Age 18 Years
Healthy Volunteers No
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
Adult True
Child True
Older Adult False

Calculated Values

Sequence: 254156605
Registered In Calendar Year 2021
Were Results Reported False
Has Single Facility False
Minimum Age Num 6
Maximum Age Num 18
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 2

Designs

Sequence: 30497394
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking Single
Outcomes Assessor Masked True

Intervention Other Names

Sequence: 26658936 Sequence: 26658937
Intervention Id 52460986 Intervention Id 52460987
Name corticosteroids, infliximab, 5-ASA, AZA Name corticosteroids, infliximab, 5-ASA, AZA

Responsible Parties

Sequence: 28863667
Responsible Party Type Principal Investigator
Name Ying HUANG
Title Chief of Gastroenterology
Affiliation Children's Hospital of Fudan University