Exclusive Enteral Nutrition vs. Infliximab in Chinese CD Patients

NCT04530877 | Withdrawn Phase 4

• 1 other identifier: twj01
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• the number of patients who reach mucosal healing at the end of treatment in Exclusive enteral nutrition group

  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.

  at the end of 8 week of treatment.

• the number of patients who reach mucosal healing at the end of treatment in Infliximab group

  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.

  at the end of 14 week of treatment.

Study Arms (2)

Exclusive enteral nutrition

EXPERIMENTAL

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).

Dietary Supplement: Exclusive Enteral Nutrition

Infliximab

ACTIVE COMPARATOR

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

Biological: Infliximab

Interventions

Infliximab BIOLOGICAL

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

Infliximab

Exclusive Enteral Nutrition 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).

Exclusive enteral nutrition

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• patients:
• 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).
• SES-CD\>4 and PCDAI \>10 at initial
• 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:
• free medical history
• had not taken antibiotics or probiotics within the 1.5 months prior to donate their fecal

You may not qualify if:

• patients who had gene mutation or combined with other intestinal diseases such as tuberculosis or EB infection
• 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.
• patients who were administered EEN, corticosteroids, immunosuppressive drugs, or biological agents prior to the study;
• patients who could not attend consecutive follow-up sessions;

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

MeSH Terms

Conditions

Crohn Disease

Interventions

Infliximab

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Ying Huang, Dr

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: August 24, 2020
• First Posted: August 28, 2020
• Study Start: October 1, 2022
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: August 9, 2022

Record last verified: 2022-08