Elimination Diet Strategies, Histologic Remission, and Clinical Follow-Up in Children With Eosinophilic Gastrointestinal Disorders: A Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Combined Clinical and Histologic Remission
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Elimination Diet (Other)
结局指标
主要结局
Combined Clinical and Histologic Remission
时间窗: 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.
次要结局
- 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)
- Number of Participants With Vitamin D Deficiency During Elimination Diet(Up to 12 months)
- Number of Participants With Anemia During Elimination Diet(Up to 12 months)
- Recurrence After Food Reintroduction(Up to 12 months after initiation of food reintroduction)
- Adherence to Elimination Diet(Up to 12 months)
- Number of Participants With a Triggering Food Identified During Food Reintroduction(Through study completion, up to 24 months)
研究者
Ali Islek
Professor of Pediatric Gastroenterology
Cukurova University