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

Inflammatory Bowel Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06353633
• Other study ID #: AHekmatdoost
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 10, 2024
• Est. completion date: December 25, 2024

Study information

• Verified date: April 2024
• Source: National Nutrition and Food Technology Institute
• Contact: Azita Hekmatdoost, MD, PhD
• Phone: 09123065084
• Email: a_hekmat2000[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 44
• Est. completion date: December 25, 2024
• Est. primary completion date: October 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease
• Inflammatory Bowel Diseases

Intervention

Dietary Supplement:
• formula
The calories needed by the person are calculated and half of the calories are provided by formulas and the other half based on the elimination diet

Behavioral:
• exclusion diet
In this group, only the elimination diet is considered as an intervention

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Nutrition and Food Technology Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PCDAI	pediatric chron disease activity index	8 weeks
Primary	CRP	c-reactive protein	8 weeks
Primary	ESR	erythrocyte sedimentation rate	8 weeks
Primary	FC	fecal calprotectin	8 weeks
Primary	Alb	serum albumin	8 weeks
Secondary	Arm Circumferance	the circumference of the arm	8 weeks
Secondary	BMI	body mass index	8 weeks
Secondary	Height	height measurement	8 weeks
Secondary	weight	body weight	8 weeks