Crohn’s disease exclusion diet (CDED): An adjuvant therapy with biologics in management of pediatric Crohn’s disease

Not Applicable

• Conditions: Digestive System; Nutritional, Metabolic, Endocrine; Paediatrics

• Registration Number: PACTR202404560083036
• Lead Sponsor: cairo university

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-03
• Last Update Posted: 29 April 2024

Recruitment & Eligibility

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

Inclusion Criteria

Patients with an active Crohn’s disease on biological treatment and conventional treatment.
Age between 5-18 years.

Exclusion Criteria

Children with Crohn’s disease on steroid therapy course.
Children less than 5 years old.
Patient with any other causes of chronic diarrhea e.g ( congenital, metabolic causes…etc)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the efficacy of combined biological and conventional treatment (5-aminosalicylic acid, and azathioprine) versus combined biological and Crohn’s disease exclusion diet regarding disease course, remission, and it`s maintenance.

Secondary Outcome Measures

Name	Time	Method
To assess the effect of CDED on the nutritional status of patients with an active Crohn’s disease.