An observational study in Eosinophilic Gastrointestinal Disorders (EGID), sponsored by Cukurova University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 2 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-08-21.
Sponsored by Cukurova University · Observational
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.
This is a prospective observational cohort study of children aged 2-17 years diagnosed with eosinophilic gastrointestinal disorders (EGIDs). Children undergoing upper and/or lower gastrointestinal endoscopy for clinical indications will be evaluated using multiple segment-specific biopsies. Patients with histologic eosinophilic infiltration consistent with an EGID, after exclusion of other relevant causes, will be eligible for inclusion.
Elimination diets used in routine clinical practice may include single-, two-, four-, or six-food elimination strategies involving commonly implicated foods such as milk, egg, soy, wheat, nuts/peanuts, and seafood. The type and extent of dietary elimination will be determined independently by the treating physician based on the patient's clinical history and clinical assessment. No dietary strategy will be assigned by the study protocol. Dietary management will be conducted with dietitian support, and nutritional status will be monitored.
Clinical symptoms, anthropometric measurements, laboratory parameters, endoscopic findings, and segment-specific histologic eosinophil counts will be prospectively recorded. Follow-up endoscopy with biopsies from the same gastrointestinal segments is planned as part of clinical care approximately 8-12 weeks after initiation of the elimination diet. Clinical and histologic responses to dietary treatment will be evaluated.
Patients achieving clinical and histologic remission will continue dietary management according to routine clinical care and will subsequently undergo planned food reintroduction. Foods will be reintroduced individually, and recurrence of symptoms and, when clinically indicated, histologic recurrence will be recorded. The study will also evaluate growth, nutritional safety, dietary adherence, and factors associated with clinical and histologic response. No additional invasive procedure will be performed solely for research purposes.
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.
Exclusion Criteria:
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
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.
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.
Time frame: 8-12 weeks after initiation of the elimination diet
Change in Weight Standard Deviation Score (SDS)
Change in weight-for-age standard deviation score (SDS) from baseline to 12 months.
Time frame: Baseline and 12 months
Change in Height Standard Deviation Score (SDS)
Change in height-for-age standard deviation score (SDS) from baseline to 12 months.
Time frame: Time Frame: Baseline and 12 months
Change in Body Mass Index Standard Deviation Score (BMI SDS)
Change in body mass index standard deviation score (BMI SDS) from baseline to 12 months.
Time frame: Baseline and 12 months
Number of Participants With Iron Deficiency During Elimination Diet
Number of participants with iron deficiency identified during elimination diet therapy based on serum iron measurements obtained as part of routine clinical care.
Time frame: Up to 12 months
Number of Participants With Vitamin B12 Deficiency During Elimination Diet
Number of participants with vitamin B12 deficiency identified during elimination diet therapy based on serum vitamin B12 measurements obtained as part of routine clinical care.
Time frame: Up to 12 months
Number of Participants With Vitamin D Deficiency During Elimination Diet
Number of participants with vitamin D deficiency identified during elimination diet therapy based on serum 25-hydroxyvitamin D measurements obtained as part of routine clinical care.
Time frame: Up to 12 months
Number of Participants With Anemia During Elimination Diet
Number of participants with anemia identified during elimination diet therapy based on hemoglobin levels below the age- and sex-appropriate reference range.
Time frame: Up to 12 months
Recurrence After Food Reintroduction
Proportion of participants developing recurrence of gastrointestinal symptoms and, when clinically assessed, histologic recurrence following stepwise food reintroduction.
Time frame: Up to 12 months after initiation of food reintroduction
Adherence to Elimination Diet
Proportion of participants who remain adherent to the prescribed elimination diet during follow-up.
Time frame: Up to 12 months
Number of Participants With a Triggering Food Identified During Food Reintroduction
Number of participants in whom at least one individual food is identified as a triggering food based on recurrence of gastrointestinal symptoms following stepwise food reintroduction. Histologic recurrence will also be recorded when follow-up endoscopy and biopsy are clinically indicated.
Time frame: Through study completion, up to 24 months
Plan to share: No — Individual participant data will not be shared due to participant privacy and confidentiality considerations.
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