Eosinophilic Gastrointestinal Disorders (EGID)
Conditions
Keywords
Elimination Diet, Histologic Remission, Dietary Therapy
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.
Detailed description
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.
Interventions
OTHERElimination 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.
Sponsors
Cukurova University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
2 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* 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. * Exclusion of other relevant causes of gastrointestinal eosinophilia.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Combined Clinical and Histologic Remission | 8-12 weeks after initiation of the elimination diet | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Weight Standard Deviation Score (SDS) | Baseline and 12 months | Change in weight-for-age standard deviation score (SDS) from baseline to 12 months. |
| Change in Height Standard Deviation Score (SDS) | Time Frame: Baseline and 12 months | Change in height-for-age standard deviation score (SDS) from baseline to 12 months. |
| Change in Body Mass Index Standard Deviation Score (BMI SDS) | Baseline and 12 months | Change in body mass index standard deviation score (BMI SDS) from baseline to 12 months. |
| Number of Participants With Iron Deficiency During Elimination Diet | Up to 12 months | Number of participants with iron deficiency identified during elimination diet therapy based on serum iron measurements obtained as part of routine clinical care. |
| Number of Participants With Vitamin B12 Deficiency During Elimination Diet | Up to 12 months | 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. |
| Number of Participants With Vitamin D Deficiency During Elimination Diet | Up to 12 months | 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. |
| Number of Participants With Anemia During Elimination Diet | Up to 12 months | Number of participants with anemia identified during elimination diet therapy based on hemoglobin levels below the age- and sex-appropriate reference range. |
| Recurrence After Food Reintroduction | Up to 12 months after initiation of food reintroduction | Proportion of participants developing recurrence of gastrointestinal symptoms and, when clinically assessed, histologic recurrence following stepwise food reintroduction. |
| Adherence to Elimination Diet | Up to 12 months | Proportion of participants who remain adherent to the prescribed elimination diet during follow-up. |
| Number of Participants With a Triggering Food Identified During Food Reintroduction | Through study completion, up to 24 months | 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. |
Countries
Turkey (Türkiye)
Contacts
CONTACTAli Islek, MD
Outcome results
None listed