Diet in Pediatric Crohn´s Disease Treated With Biologics

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-14

Study Completion Date

2023-06-20

Brief Summary

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Cded in remission patients with high calprotectin

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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.

Conditions

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Crohn's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Diet

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.

Group Type EXPERIMENTAL

Crohn's disease exclusion diet

Intervention Type DIETARY_SUPPLEMENT

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

Control

Patients with normal treatment( biologic treatment indicated for CD)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Crohn's disease exclusion diet

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

Intervention Type DIETARY_SUPPLEMENT

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

Minimum Eligible Age

1 Month

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No