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Exclusive Enteral Nutrition vs. Infliximab in Chinese CD Patients

NCT04530877 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2022-08-09

No results posted yet for this study

Summary

prospectively compared Exclusive Enteral Nutrition with Infliximab in the clinical outcomes, mucosal healing, nutrition improvements, adverse effects and gastrointestinal microbiota changes on Chinese Children With active Crohn's Disease

Conditions

Interventions

BIOLOGICAL

Infliximab

Infliximab, a monoclonal antibody-targeting tumor necrosis factor (TNF), is one of the primary treatment strategies for active pediatric CD

DIETARY_SUPPLEMENT

Exclusive Enteral Nutrition

the administration of a liquid formula diet with the exclusion of all other regular food for 6-8 weeks， the volume was determined according to the energy needs of the patient. All patients received high energy intakes (\>110%-120% of the average requirement).

Sponsors & Collaborators

  • Children's Hospital of Fudan University

    lead OTHER

Principal Investigators

  • Ying Huang, Dr · Department of Gastroenterology, Pediatric Inflammatory Bowel Disease Research Center, Children's Hospital of Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-01
Primary Completion
2024-09-30
Completion
2024-09-30

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04530877 on ClinicalTrials.gov