Exclusive Enteral Nutrition vs. Infliximab in Chinese CD Patients

NCT ID: NCT04530877

Last Updated: 2022-08-09

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2024-09-30

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

Conditions

Crohn's Disease; Exclusive Enteral Nutrition; Infliximab; Mucosal Healing

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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).

Group Type: EXPERIMENTAL

Exclusive Enteral Nutrition

Intervention Type: DIETARY_SUPPLEMENT

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).

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

Group Type: ACTIVE_COMPARATOR

Infliximab

Intervention Type: BIOLOGICAL

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

Interventions

Infliximab

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

Intervention Type: BIOLOGICAL

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).

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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;

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Children's Hospital of Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Ying HUANG

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ying Huang, Dr

Role: STUDY_CHAIR

Department of Gastroenterology, Pediatric Inflammatory Bowel Disease Research Center, Children's Hospital of Fudan University

Other Identifiers

twj01

Identifier Type: -

Identifier Source: org_study_id