Exclusive Enteral Nutrition vs. Infliximab in Chinese CD Patients

Phase 4

Withdrawn

• Conditions: Crohn's Disease; Infliximab; Mucosal Healing; Exclusive Enteral Nutrition
• Interventions: Dietary Supplement: Exclusive Enteral Nutrition; Biological: Infliximab

• Registration Number: NCT04530877
• Lead Sponsor: Children's Hospital of Fudan University

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-24
• Study First Submitted QC: 2020-08-25
• Study First Posted: 2020-08-28
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-05
• Last Update Posted: 2022-08-09
• Study Start: 2022-10-01
• Primary Completion: 2024-09-30
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exclusive enteral nutrition	Exclusive Enteral Nutrition	the administration of a liquid formula diet with the exclusion of all other regular food for 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).
Infliximab	Infliximab	the participants with active CD accept anti-TNF therapy (Infliximab) at 0week, 2week, 6week, 14week. Infliximab, a monoclonal antibody-targeting tumor necrosis factor (TNF), is one of the primary treatment strategies for active pediatric CD

Primary Outcome Measures

Name	Time	Method
the number of patients who reach mucosal healing at the end of treatment in Exclusive enteral nutrition group	at the end of 8 week of treatment.	the mucosal healing was defined as Simple Endoscopic Score for CD （SES-CD ）≤4 at the end of treatment . For the SES-CD, the intestine is divided into 5 anatomic segments under the endoscopic vision: rectum, left side of the colon segment, transverse colon, right side of the colon segment, and ileum. Items of interest include ulcer size, estimates of the ulcerated and affected surface, and the presence of luminal narrowing. The SES-CD score is calculated by combining scores of individual segments. Overall SES-CD scores are classified into 4 disease categories: none, 0 to 2; mild 2 to 4; moderate 5 to 15; and severe\>16.
the number of patients who reach mucosal healing at the end of treatment in Infliximab group	at the end of 14 week of treatment.	the mucosal healing was defined as Simple Endoscopic Score for CD （SES-CD ）≤4 at the end of treatment . For the SES-CD, the intestine is divided into 5 anatomic segments under the endoscopic vision: rectum, left side of the colon segment, transverse colon, right side of the colon segment, and ileum. Items of interest include ulcer size, estimates of the ulcerated and affected surface, and the presence of luminal narrowing. The SES-CD score is calculated by combining scores of individual segments. Overall SES-CD scores are classified into 4 disease categories: none, 0 to 2; mild 2 to 4; moderate 5 to 15; and severe\>16.