The Effect of Exclusion Diet for Crohn's Disease Plus Enteral Nutrition on Children and Adolescents With Crohn's Disease

National Nutrition and Food Technology Institute

Status: Not yet enrolling

Conditions: Inflammatory Bowel Diseases

Treatments: Dietary Supplement: formula; Behavioral: exclusion diet

Study type: Interventional

Funder types: Other

Identifiers

NCT06353633

AHekmatdoost

Details and patient eligibility

About

In this study, children and adolescents with active Crohn's disease are placed in two intervention groups, the first group receives only an exclusion diet and the second group receives an exclusion diet plus formula.

Enrollment: 44 estimated patients

Sex: All

Ages: 4 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• children aged 4 to 18 years with active Crohn's disease
• Pediatric Crohn's Disease Activity Index (PCDAI) ≥10 and ≤40

Exclusion criteria

• Patients who receiving concurrent remission-inducing drugs such as steroids, 5-ASA, methotrexate, or antibiotics, as well as patients receiving induction doses of a biologic

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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44 participants in 2 patient groups

exclusion diet along with formula

Active Comparator group

Treatment:

Dietary Supplement: formula

Behavioral: exclusion diet

A group that receives only exclusion diet

Active Comparator group

Treatment:

Behavioral: exclusion diet