Exclusive Enteral Nutrition vs. Infliximab in Chinese CD Patients
Primary Purpose
Crohn's Disease, Exclusive Enteral Nutrition, Infliximab
Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Infliximab
Exclusive Enteral Nutrition
Sponsored by
About this trial
This is an interventional treatment trial for Crohn's Disease
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
- 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;
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Exclusive enteral nutrition
Infliximab
Arm 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).
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
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04530877
First Posted
August 24, 2020
Last Updated
August 5, 2022
Sponsor
Children's Hospital of Fudan University
1. Study Identification
Unique Protocol Identification Number
NCT04530877
Brief Title
Exclusive Enteral Nutrition vs. Infliximab in Chinese CD Patients
Official Title
Comparative Effectiveness of Exclusive Enteral Nutrition and Infliximab in Chinese Children With Active Crohn's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Withdrawn
Why Stopped
no funding
Study Start Date
October 1, 2022 (Anticipated)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Hospital of Fudan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease, Exclusive Enteral Nutrition, Infliximab, Mucosal Healing
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exclusive enteral nutrition
Arm Type
Experimental
Arm 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).
Arm Title
Infliximab
Arm Type
Active Comparator
Arm 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
Intervention Type
Biological
Intervention Name(s)
Infliximab
Intervention Description
Infliximab, a monoclonal antibody-targeting tumor necrosis factor (TNF), is one of the primary treatment strategies for active pediatric CD
Intervention Type
Dietary Supplement
Intervention Name(s)
Exclusive Enteral Nutrition
Intervention Description
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).
Primary Outcome Measure Information:
Title
the number of patients who reach mucosal healing at the end of treatment in Exclusive enteral nutrition group
Description
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.
Time Frame
at the end of 8 week of treatment.
Title
the number of patients who reach mucosal healing at the end of treatment in Infliximab group
Description
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.
Time Frame
at the end of 14 week of treatment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ying Huang, Dr
Organizational Affiliation
Department of Gastroenterology, Pediatric Inflammatory Bowel Disease Research Center, Children's Hospital of Fudan University
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
Exclusive Enteral Nutrition vs. Infliximab in Chinese CD Patients
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