Exclusive Enteral Nutrition vs. Infliximab in Chinese CD Patients

Crohn's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04530877
• Other study ID #: twj01
• Status: Withdrawn
• Phase: Phase 4
• Start date: October 1, 2022
• Est. completion date: September 30, 2024

Study information

• Verified date: August 2022
• Source: Children's Hospital of Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

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;

Related Conditions & MeSH terms

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

Intervention

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

Dietary Supplement:
• 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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.