Elimination Diet Strategies and Histologic Remission in Children With Eosinophilic Gastrointestinal Disorders
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2-18
SponsorCukurova University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Elimination Diet
Other interventionElimination 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.
Treatment groups
34 Participants
are divided into 1 treatment groupGroup A: Children With Eosinophilic Gastrointestinal Disorders1 intervention
Trial outcomes
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.
Time frame
8-12 weeks after initiation of the elimination dietSecondary outcomes
1
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 months2
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 months3
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 months4
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 monthsSponsors and contacts
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Source ClinicalTrials.gov