The Effect of Exclusion Diet for Crohn's Disease Plus Enteral Nutrition on Children and Adolescents With Crohn's Disease
Not Applicable
Not yet recruiting
- Conditions
- Inflammatory Bowel Diseases
- Interventions
- Behavioral: exclusion dietDietary Supplement: formula
- Registration Number
- NCT06353633
- Lead Sponsor
- National Nutrition and Food Technology Institute
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 44
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A group that receives only exclusion diet exclusion diet - exclusion diet along with formula exclusion diet - exclusion diet along with formula formula -
- Primary Outcome Measures
Name Time Method CRP 8 weeks c-reactive protein
ESR 8 weeks erythrocyte sedimentation rate
FC 8 weeks fecal calprotectin
PCDAI 8 weeks pediatric chron disease activity index
Alb 8 weeks serum albumin
- Secondary Outcome Measures
Name Time Method weight 8 weeks body weight
Arm Circumferance 8 weeks the circumference of the arm
BMI 8 weeks body mass index
Height 8 weeks height measurement