Pediatric Crohn's Disease
Conditions
Interventions
Group CDED:The first stage : induction remission period, for 6 weeks, half of the patient 's diet was CDED diet, and half was treated with PEN (small peptide, Nestle Health Science)
The second stage : for 6 weeks, patients can choose more food types, with 25 % PEN treatment
The third stage : maintain the remission stage for nine months. The patients were freely matched according to the core principles of CDED diet and treated with 25 % PEN. The fourth stage : stop PEN tr
Group EEN:All the energy needs of patients in the EEN group came from the small peptide nutrition powder.
Sponsors
Beijing Children's Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
4 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1 ) Children with mild to moderate CD, aged 4-18 years ; 2 ) Pediatric crohn 's disease activity index ( PCDAI ) score = 10 points and = 37.5 points ; 3 ) The legal guardian of the child signed the informed consent form. If the child was 8 years old or above, they should jointly sign an informed consent form and agree to participate in the study.
Exclusion criteria
Exclusion criteria: 1 ) PCDAI 40 points 2) current use of glucocorticoids, current or past use of biological agents; Patients who took a steady dose of immunomodulators for the first 8 weeks of enrollment, or began to use thiopurine after week 3, or methotrexate after week 6 could be included 3) fistula or stenosis of CD, active perianal disease, combined with active arthritis, uveitis, primary sclerosing cholangitis 4) have undergone enterectomy 5) participated in other clinical studies within 3 months 6) single gene defect 7) other conditions in which participation was not considered appropriate by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease remission rate and response rate in the 6th week of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| PCDAI scores were evaluated at baseline and at 6 and 12 weeks after enrollment, and simplified CD endoscopic score (SES-CD) was evaluated at baseline and 12 weeks after treatment;Inflammatory markers were measured at baseline and 6 and 12 weeks after enrollment : blood routine, CRP, ESR, blood biochemistry, fecal calprotectin, blood inflammatory factors TNF-a, IL-6 / IL-10, IL-1ß, IL-17A, IFN-?;Application of nutritional risk screening and nutritional status assessment at baseline and 3, 6, 9, and 12 weeks after enrollment;Growth and development indicators : height, weight, body mass index were measured at baseline and at 3 weeks, 6 weeks, 9 week, and 12 weeks after enrollment.;Nutritional indicators were measured at baseline and at weeks 6 and 12 after enrollment, including serum albumin, serum prealbumin, lymphocyte count, hemoglobin, serum ferritin, total ferritin binding rate, trace elements (zinc), folate, vitamin B12, and 25 hydroxyvitamin D;Bone metabolic markers : serum 25 ( OH ) D3, serum calcium, serum phosphorus, bone alkaline phosphatase, bone mineral density were measured at baseline and at 6 and 12 weeks after enrollment;Clinical tolerability and compliance: evaluated at 3, 6, 9, and 12 weeks after enrollment;Detection of intestinal flora diversity : Fresh fecal samples of patients were collected at the time of enrollment, 6 weeks and 12 weeks after treatment, and the changes of intestinal flora in children at different stages of diet treatment were obtained by metagenomic sequencing;Detection of small molecule metabolites : Fecal and serum samples were collected at the time of enrollment, 6 weeks and 12 weeks after treatment; | — |
Countries
China
Contacts
Public ContactWu Jie
Department of Gastroenterology, Beijing Children's Hospital, Capital Medical University
Outcome results
None listed