Diet in Pediatric Crohn´s Disease Treated With Biologics

Study Overview
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Brief Summary
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Cded in remission patients with high calprotectin

Detailed Description
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Due to the success of diet in achieving remission in mild-moderate forms of the disease, and an increasing number of patients with loss of response to available drugs despite increasing dose and pathophysiology of the disease, the aim of the present study is to evaluate whether there is response with the addition of diet therapy in patients with moderate/severe forms of CD receiving biologic therapy (infliximab or adalimumab) and presenting active disease.

Official Title
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Diet as Adjuvant Therapeutics in the Era of Biologics in Pediatric-onset Crohn's Disease.

Conditions
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Crohn's Disease

Intervention / Treatment
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* Dietary Supplement: Crohn's disease exclusion diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients under 18 years of age With a diagnosis of CD Who have completed remission induction with biologic therapy Who are on maintenance biologic therapy Present calprotectin values higher than the limit values established by the laboratory (higher than 250 ug/g). Exclusion Criteria: Children who are unable to receive enteral dietary intake Comorbidities affecting nutritional status and/or bone metabolism, growth or pubertal development Children already on special diets

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diet<br>Patients will do biologic treatment according to international guidelines and will do Crohns Disease Exclusion Diet( modulen- phase one ant two CDED) for 12 weeks.They will be monitored periodically by interview and physical examination by physician and nutritionist, laboratory, fecal calprotectin. | Dietary Supplement: Crohn's disease exclusion diet<br>* Patients will receive, in addition to their normal treatment, polymeric formula + diet<br>|
| No Intervention: Control<br>Patients with normal treatment( biologic treatment indicated for CD) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with calprotectin less than 250 at week 12 | Number of participants who achieve normal fecal calprotectin after the diet | week 12 | 
| Level of calprotectin | To evaluate the change of the calprotectin value at 0 and 12 weeks in patients with or without the addition of dietary therapy. | week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence | Number of patients that were able to continue the diet and not drop out during at least the 12 weeks of the study. | 12 weeks |