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

April 2, 2024 updated by: Dr Azita Hekmatdoost, National Nutrition and Food Technology Institute
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: exclusion diet along with formula
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
Active Comparator: A group that receives only exclusion diet
Behavioral: exclusion diet
In this group, only the elimination diet is considered as an intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PCDAI
Time Frame: 8 weeks
pediatric chron disease activity index
8 weeks
CRP
Time Frame: 8 weeks
c-reactive protein
8 weeks
ESR
Time Frame: 8 weeks
erythrocyte sedimentation rate
8 weeks
FC
Time Frame: 8 weeks
fecal calprotectin
8 weeks
Alb
Time Frame: 8 weeks
serum albumin
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Arm Circumferance
Time Frame: 8 weeks
the circumference of the arm
8 weeks
BMI
Time Frame: 8 weeks
body mass index
8 weeks
Height
Time Frame: 8 weeks
height measurement
8 weeks
weight
Time Frame: 8 weeks
body weight
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Nutrition and Food Technology Institute

Investigators

  • Study Director: Azita Hekmatdoost, MD, PhD, NNFTRI

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 10, 2024

Primary Completion (Estimated)

October 20, 2024

Study Completion (Estimated)

December 25, 2024

Study Registration Dates

First Submitted

February 23, 2024

First Submitted That Met QC Criteria

April 2, 2024

First Posted (Actual)

April 9, 2024

Study Record Updates

Last Update Posted (Actual)

April 9, 2024

Last Update Submitted That Met QC Criteria

April 2, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AHekmatdoost

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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