Exclusive Enteral Nutrition vs. Infliximab in Chinese CD Patients

Comparative Effectiveness of Exclusive Enteral Nutrition and Infliximab in Chinese Children With Active Crohn's Disease

NCT04530877•Children's Hospital of Fudan University

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

Eligibility

Age

1 - 18 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•patients:
•1. Pediatric active Crohn's disease ( CD) patients who were newly diagnosed at the Children's Hospital of Fudan University from October 2020 to Sep 2022，CD was diagnosed according to the Porto criteria and based on a combination of history, physical and laboratory examination, endoscopy with histology, and imaging of the small bowel (capsule endoscopy or magnetic resonance imaging or enhanced computerized tomography).
•2. SES-CD\>4 and PCDAI \>10 at initial
•3. For the patients whose fecal will be analyzed shouldn't take antibiotics or probiotics within the 1.5 months prior to the study and during the treatment.
•healthy controls:
•1. free medical history
•2. had not taken antibiotics or probiotics within the 1.5 months prior to donate their fecal

Exclusion Criteria

•1. patients who had gene mutation or combined with other intestinal diseases such as tuberculosis or EB infection
•2. for patients in the EEN group who could not finish the daily prescribed volume of formula for any reason; for the patients in the IFX group who could not finish the first 4 times IFX injection for any reason.
•3. patients who were administered EEN, corticosteroids, immunosuppressive drugs, or biological agents prior to the study;
•4. patients who could not attend consecutive follow-up sessions;

Key Dates

Start Date

October 1, 2022

Primary Completion Date

September 30, 2024

Completion Date

September 30, 2024

Last Updated

August 9, 2022

Conditions

Crohn's DiseaseExclusive Enteral NutritionInfliximabMucosal Healing

Interventions

Infliximab

BIOLOGICAL

Exclusive Enteral Nutrition

DIETARY_SUPPLEMENT

A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease

NCT06226883

Inflammatory Bowel DiseasesCrohn's Disease

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RECRUITINGPHASE3

An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease

NCT07184931

Crohn's Disease

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 9, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Exclusive Enteral Nutrition vs. Infliximab in Chinese CD Patients

Inclusion Criteria

Exclusion Criteria

A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease

An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease

DB-3Q bmMSC-EVs in Patients With Perianal Fistulizing Crohn's Disease

Prophylactic Dexamethasone Before Infliximab in Moderate-to-Severe IBD

A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease

Safety of Allogeneic Human Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) to Treat Perianal Fistulas w/ Crohn's Disease