Common symptoms of Crohn's disease in children
Conditions
Interventions
Nutrition group:After admission, CDED dietary therapy was initiated. Specifically: CDED food principles/types involve a stepwise, high-protein, low-animal-fat, low-red-meat, low-gluten, and low-additi
Phase 2: Less restrictive period (7–12 weeks)
Phase 3: Maintenance period (=13 weeks, with no specific end date).
Control group:After admission, EEN dietary therapy was initiated, consisting of the following steps: (1) starting with total enteral nutrition, (2) transitioning to partial enteral nutrition, and (3)
Delphi expert panel:None
Sponsors
Shenzhen Children’s Hospital
Eligibility
Sex/Gender
All
Age
6 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1. Expert Inclusion Criteria: (1) Nurses, physicians, and dietitians with a bachelor's degree or higher and intermediate-level title or above; (2) At least 10 years of clinical work experience in the fields of gastroenterology and nutrition; (3) Demonstrated interest in and willingness to participate in this study. 2. Criteria for conducting controlled studies to validate the effectiveness of nutritional dietary interventions in pediatric CD patients: (1) Diagnosis conforms to the "Consensus on Diagnosis of Pediatric Inflammatory Bowel Disease" and refers to the "Guangzhou Consensus on Diagnosis and Treatment of Inflammatory Bowel Disease"; (2) Administer initial infusions of TNF-a monoclonal antibody at a dose of 5 mg/kg at weeks 0, 2, and 6, showing clinical response or clinical remission—clinical response defined as a decrease in Pediatric Crohn’s Disease Activity Index (PCDAI) score of more than 15 points, and clinical remission defined as a PCDAI score <=10; subsequent doses of TNF-a monoclonal antibody continue every 8 weeks at 5 mg/kg; (3) 6 <= age <= 18 years; (4) Presence of intestinal absorptive function; (5) Informed consent obtained.
Exclusion criteria
Exclusion criteria: Criteria for conducting controlled studies to validate the effectiveness of nutritional dietary interventions in pediatric CD patients: 1.Intestinal intolerance to EN; 2.Patients with nervous system disorders, thyroid gland hyperfunction or serious heart disorders or children with malignant tumours.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Inflammatory indicators;nutritional indicators; | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of clinical efficacy;quality of life level.;Evaluation of adverse reactions; | — |
Countries
China
Contacts
Public ContactWu Lijun
Shenzhen Children’s Hospital
Outcome results
None listed