Diet in Pediatric Crohn´s Disease Treated With Biologics

Hospital Italiano de Buenos Aires

Status: Completed

Conditions: Crohn's Disease

Treatments: Dietary Supplement: Crohn's disease exclusion diet

Study type: Interventional

Funder types: Other

Identifiers

NCT05034458

5992

Details and patient eligibility

About

Cded in remission patients with high calprotectin

Full description

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.

Enrollment: 30 patients

Sex: All

Ages: 1 month to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Diet

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Crohn's disease exclusion diet

Control

No Intervention group

Description:

Patients with normal treatment( biologic treatment indicated for CD)