Exclusive Enteral Nutrition vs. Infliximab in Chinese CD Patients

Fudan University

Status and phase: Withdrawn; Phase 4

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

Treatments: Biological: Infliximab; Dietary Supplement: Exclusive Enteral Nutrition

Study type: Interventional

Funder types: Other

Identifiers

NCT04530877

twj01

Details and patient eligibility

About

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

Sex: All

Ages: 1 to 18 years old

Volunteers: Accepts Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

Exclusive enteral nutrition

Experimental group

Description:

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).

Treatment:

Dietary Supplement: Exclusive Enteral Nutrition

Infliximab

Active Comparator group

Description:

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

Treatment:

Biological: Infliximab