Diet in Pediatric Crohn´s Disease Treated With Biologics

Hospital Italiano de Buenos Aires30 enrolled

Overview

Cded in remission patients with high calprotectin

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Crohn's Disease

Interventions

Crohn's disease exclusion dietDIETARY_SUPPLEMENT

Patients will receive, in addition to their normal treatment, polymeric formula + diet

Eligibility

Sex: ALLMin age: 1 MonthMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Hospital Italiano de Buenos Aires

Buenos Aires, Argentina

Outcomes

Primary Outcomes

Number of Participants with calprotectin less than 250 at week 12

Number of participants who achieve normal fecal calprotectin after the diet

Time frame: 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.

Time frame: week 12

Secondary Outcomes

Adherence

Number of patients that were able to continue the diet and not drop out during at least the 12 weeks of the study.

Time frame: 12 weeks

Data from ClinicalTrials.gov

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