Diet in Pediatric Crohn´s Disease Treated With Biologics

Not Applicable

Completed

• Conditions: Crohn's Disease
• Interventions: Dietary Supplement: Crohn's disease exclusion diet

• Registration Number: NCT05034458
• Lead Sponsor: Hospital Italiano de Buenos Aires

Brief Summary

Cded in remission patients with high calprotectin

Detailed 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.

Study Timeline

• Study Start: 2021-05-14
• Study First Submitted: 2021-06-12
• Study First Submitted QC: 2021-08-28
• Study First Posted: 2021-09-05
• Primary Completion: 2023-06-01
• Study Completion: 2023-06-20
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-21
• Last Update Posted: 2023-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diet	Crohn's disease exclusion 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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital Italiano de Buenos Aires; 🇦🇷 Buenos Aires, Argentina