Inflammatory Bowel Diseases
Conditions
Keywords
PEN
Brief summary
In this study, children and adolescents with active Crohn's disease are placed in two intervention groups, the first group receives only an exclusion diet and the second group receives an exclusion diet plus formula.
Interventions
DIETARY_SUPPLEMENTformula
The calories needed by the person are calculated and half of the calories are provided by formulas and the other half based on the elimination diet
BEHAVIORALexclusion diet
In this group, only the elimination diet is considered as an intervention
Sponsors
National Nutrition and Food Technology Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* children aged 4 to 18 years with active Crohn's disease * Pediatric Crohn's Disease Activity Index (PCDAI) ≥10 and ≤40
Exclusion criteria
* Patients who receiving concurrent remission-inducing drugs such as steroids, 5-ASA, methotrexate, or antibiotics, as well as patients receiving induction doses of a biologic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Alb | 8 weeks | serum albumin |
| PCDAI | 8 weeks | pediatric chron disease activity index |
| CRP | 8 weeks | c-reactive protein |
| ESR | 8 weeks | erythrocyte sedimentation rate |
| FC | 8 weeks | fecal calprotectin |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| BMI | 8 weeks | body mass index |
| Height | 8 weeks | height measurement |
| weight | 8 weeks | body weight |
| Arm Circumferance | 8 weeks | the circumference of the arm |
Contacts
Primary ContactAzita Hekmatdoost, MD, PhD
Outcome results
None listed