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

NCT06353633 | Not Yet Recruiting DMC

• 1 other identifier: AHekmatdoost
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Inflammatory Bowel Diseases

Keywords

PEN

Outcome Measures

Primary Outcomes (5)

• PCDAI

  pediatric chron disease activity index

  8 weeks

• CRP

  c-reactive protein

  8 weeks

• ESR

  erythrocyte sedimentation rate

  8 weeks

• FC

  fecal calprotectin

  8 weeks

• Alb

  serum albumin

  8 weeks

Secondary Outcomes (4)

• Arm Circumferance

  8 weeks

• BMI

  8 weeks

• Height

  8 weeks

• weight

  8 weeks

Study Arms (2)

exclusion diet along with formula

ACTIVE COMPARATOR

Dietary Supplement: formula; Behavioral: exclusion diet

A group that receives only exclusion diet

ACTIVE COMPARATOR

Behavioral: exclusion diet

Interventions

formula DIETARY_SUPPLEMENT

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

exclusion diet along with formula

exclusion diet BEHAVIORAL

In this group, only the elimination diet is considered as an intervention

A group that receives only exclusion diet; exclusion diet along with formula

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Nutrition and Food Technology Institute: lead

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

Food, Formulated; Elimination Diets

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Foods, Specialized; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Diet; Nutritional Physiological Phenomena

Study Officials

• Azita Hekmatdoost, MD, PhD

  NNFTRI

  STUDY DIRECTOR

Central Study Contacts

Azita Hekmatdoost, MD, PhD

CONTACT

09123065084; a_hekmat2000@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 23, 2024
• First Posted: April 9, 2024
• Study Start: April 10, 2024
• Primary Completion: October 20, 2024
• Study Completion: December 25, 2024
• Last Updated: April 9, 2024

Record last verified: 2024-04