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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06353633
Other study ID # AHekmatdoost
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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