Elimination Diet Strategies and Histologic Remission in Children With Eosinophilic Gastrointestinal Disorders

NCT07779772 | Recruiting

• 1 other identifier: TAY-2026-18178
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective observational cohort study aims to evaluate clinical and histologic outcomes of elimination diets in children aged 2-17 years with eosinophilic gastrointestinal disorders (EGIDs). The type of elimination diet will be determined by the treating physician as part of routine clinical care according to each patient's clinical characteristics. The study will not assign participants to a specific dietary treatment. Clinical symptoms, histologic findings, growth parameters, and nutritional outcomes will be prospectively recorded. Follow-up endoscopy and biopsies performed as part of routine clinical care will be used to assess histologic response. Food reintroduction and disease recurrence will also be evaluated during follow-up.

Conditions

Eosinophilic Gastrointestinal Disorders (EGID)

Keywords

Elimination Diet; Histologic Remission; Dietary Therapy

Outcome Measures

Primary Outcomes (1)

• Combined Clinical and Histologic Remission

  Proportion of participants achieving both a clinically meaningful reduction in symptom score and histologic remission, defined as segment-specific eosinophil counts decreasing below the predefined histologic threshold.

  8-12 weeks after initiation of the elimination diet

Secondary Outcomes (10)

• Change in Weight Standard Deviation Score (SDS)

  Baseline and 12 months

• Change in Height Standard Deviation Score (SDS)

  Time Frame: Baseline and 12 months

• Change in Body Mass Index Standard Deviation Score (BMI SDS)

  Baseline and 12 months

• Number of Participants With Iron Deficiency During Elimination Diet

  Up to 12 months

• Number of Participants With Vitamin B12 Deficiency During Elimination Diet

  Up to 12 months

Study Arms (1)

Children With Eosinophilic Gastrointestinal Disorders

Children aged 2-17 years with eosinophilic gastrointestinal disorders who receive an elimination diet as part of routine clinical care. The type and extent of food elimination are determined independently by the treating physician based on clinical assessment and are not assigned by the study protocol.

Other: Elimination Diet

Interventions

Elimination Diet OTHER

Elimination diets may include single-, two-, four-, or six-food elimination strategies involving milk, egg, soy, wheat, nuts/peanuts, and seafood. The dietary strategy is determined by the treating physician as part of routine clinical care based on each patient's clinical characteristics. The study protocol does not assign or modify the dietary treatment.

Children With Eosinophilic Gastrointestinal Disorders

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children aged 2-17 years evaluated at the Pediatric Gastroenterology Unit of Cukurova University who undergo gastrointestinal endoscopy for clinical indications and are diagnosed with an eosinophilic gastrointestinal disorder based on clinical and histologic findings after exclusion of other relevant causes of gastrointestinal eosinophilia.

You may qualify if:

• Age 2-17 years.
• Presence of gastrointestinal symptoms such as abdominal pain, vomiting, diarrhea, hematemesis, or hematochezia.
• Undergoing upper and/or lower gastrointestinal endoscopy for a clinical indication.
• Histologic eosinophilic infiltration consistent with an eosinophilic gastrointestinal disorder.

You may not qualify if:

• Inflammatory bowel disease, parasitic infection, celiac disease, drug-associated enteropathy, hypereosinophilic syndrome, or other identified causes of gastrointestinal eosinophilia.
• Known primary immunodeficiency.
• Active malignancy.
• Systemic rheumatologic disease.

Sponsors & Collaborators

• Cukurova University: lead

Study Sites (1)

Cukurova University Balcali Hospital

Adana, Sarıcam, 01330, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Eosinophilic Esophagitis

Interventions

Elimination Diets

Condition Hierarchy (Ancestors)

Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Central Study Contacts

Ali Islek, MD

CONTACT

903223386060 (158); aislek@cu.edu.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatric Gastroenterology

Study Record Dates

• First Submitted: August 11, 2026
• First Posted: August 21, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: August 21, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)