Combined Application of EEN in the Induction of Remission in PUC

NCT04999241 | Not Yet Recruiting Phase 4

• 1 other identifier: UC1.2
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Exclusive Enteral Nutrition; Ulcerative Colitis; Children

Outcome Measures

Primary Outcomes (1)

• 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.

  12 week after intervention

Secondary Outcomes (2)

• sustained corticosteroid-free clinical remission rate

  1 year after intervention

• Treatment modification rate

  1 year after intervention

Study Arms (2)

EEN combined therapy group

EXPERIMENTAL

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

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

Combination Product: regular food

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.

Also known as: corticosteroids, infliximab, 5-ASA, AZA

EEN combined therapy group

regular food COMBINATION_PRODUCT

Administration of regular food in the induction phase and the later time.

Also known as: corticosteroids, infliximab, 5-ASA, AZA

Non EEN combination group

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Newly diagnosed UC
• Years 6 to 18
• Moderate to severe disease activity at diagnosis

You may not qualify if:

• With mild disease activity at diagnosis
• Had been treated with corticosteroids or biologics

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Adrenal Cortex Hormones; Infliximab; Mesalamine

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; meta-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Aminosalicylic Acids; Salicylates; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols

Study Officials

• Ying Huang

  Children's Hospital of Fudan University

  STUDY DIRECTOR

Central Study Contacts

Cui fang Zheng

CONTACT

8615221881022; zhengcuifang2@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Gastroenterology

Study Record Dates

• First Submitted: August 5, 2021
• First Posted: August 10, 2021
• Study Start: March 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 3, 2024

Record last verified: 2024-07