Eosinophilic Gastrointestinal Disorders (EGID)NCT07779772
Elimination Diet Strategies and Histologic Remission in Children With Eosinophilic Gastrointestinal Disorders
An observational study of Eosinophilic Gastrointestinal Disorders (EGID), run by Cukurova University at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Eosinophilic Gastrointestinal Disorders (EGID)
- What is being tested?
- Elimination Diet
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2026to 1 Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Cukurova University Balcali Hospital
Adana, Sarıcam, 01330
Ali Islek, MD, 903223386060 (158), aislek@cu.edu.tr
About this study
Official title: Elimination Diet Strategies, Histologic Remission, and Clinical Follow-Up in Children With Eosinophilic Gastrointestinal Disorders: A Prospective Cohort Study
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.
Read the 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.
- Being tested
- Elimination Diet
- Keywords
- Elimination Diet, Histologic Remission, Dietary Therapy
- Medical subject headings
- Eosinophilic Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elimination DietOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Elimination Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8-12 weeks after initiation of the elimination diet
Secondary outcomes (10)
Change in Weight Standard Deviation Score (SDS)
Change in weight-for-age standard deviation score (SDS) from baseline to 12 months.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through study completion, up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start1 Jul 2026
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eosinophilic Gastrointestinal Disorders (EGID)Studies of the same condition, open and under way.
- More trials run by Cukurova UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Islek, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07779772
- Sponsor's protocol ID
- TAY-2026-18178
- Status last verified
- Aug 2026
- First submitted
- 11 Aug 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to participant privacy and confidentiality considerations.
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elimination Diet Strategies, Histologic Remission, and Clinical Follow-Up in Children With Eosinophilic Gastrointestinal Disorders: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07779772
- Acronym / sponsor ID
- TAY-2026-18178
- Keywords
- Elimination Diet, Histologic Remission, Dietary Therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 21 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children With Eosinophilic Gastrointestinal Disorders | – | Other: Elimination DietChildren 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. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elimination DietElimination 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. | Other | Children With Eosinophilic Gastrointestinal Disorders |
Primary outcome
Combined Clinical and Histologic Remission
Time frame: 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.
10 secondary outcomes
Change in Weight Standard Deviation Score (SDS)
Time frame: Baseline and 12 months
Change in Height Standard Deviation Score (SDS)
Time frame: Time Frame: Baseline and 12 months
Change in Body Mass Index Standard Deviation Score (BMI SDS)
Time frame: Baseline and 12 months
Number of Participants With Iron Deficiency During Elimination Diet
Time frame: Up to 12 months
Number of Participants With Vitamin B12 Deficiency During Elimination Diet
Time frame: Up to 12 months
Number of Participants With Vitamin D Deficiency During Elimination Diet
Time frame: Up to 12 months
Number of Participants With Anemia During Elimination Diet
Time frame: Up to 12 months
Recurrence After Food Reintroduction
Time frame: Up to 12 months after initiation of food reintroduction
Adherence to Elimination Diet
Time frame: Up to 12 months
Number of Participants With a Triggering Food Identified During Food Reintroduction
Time frame: Through study completion, up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to participant privacy and confidentiality considerations.
Related trials for Eosinophilic Gastrointestinal Disorders (EGID)
Active, not recruitingPhase 2
A Study to Learn How Well Dupilumab Works in Adult and Adolescent Participants With Eosinophilic Gastritis With or Without Eosinophilic Duodenitis and the Side Effects it May Have
Eosinophilic Gastritis (EoG), Eosinophilic Duodenitis (EoD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eosinophilic Gastrointestinal Disorders (EGID), run by Cukurova University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ali Islek, MD (903223386060 (158), aislek@cu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Combined Clinical and Histologic Remission (time frame: 8-12 weeks after initiation of the elimination diet). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.