Quantitative Measurement of Stool and Urine Gluten Immunogenic Peptides in Patients With Non-celiac Gluten Sensitivity and Healthy Patients: A Placebo-controlled Study Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Stool gluten immunogenic peptides (GIP) level after administration of gluten compared to baseline level on GFD.
研究概览
简要总结
Non-celiac gluten sensitivity (NCGS) is an emerging clinical entity defined as the presence of intestinal and/or extraintestinal symptoms induced by the ingestion or gluten and relieved by a gluten free diet (GFD) in patients without celiac disease or wheat allergy. The pathologic mechanism of the disorder is unknown, and there are no known biomarkers or associated histopathologic findings. In this prospective, randomized controlled trail, we are investigating the utility of patient reported symptom questionnaires, as well as stool gluten and urine quantification tools in patients with NCGS and healthy controls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients > 18 years of age
- •Patients willing to maintain gluten free diet for 6 weeks
排除标准
- •Patients < 18 years of age
- •Patients with positive serology suggestive of celiac disease and/or biopsy-proven celiac disease and/or Human leukocyte antigen (HLA) DQ2 or DQ8 positivity.
- •Patients with a diagnosis of inflammatory bowel disease
- •Patients with a diagnosis of acute gastroenteritis
- •Patients who are pregnant
- •Type 1 Diabetes Mellitus
- •Exclusion criteria (healthy controls):
- •Celiac disease
- •Inflammatory bowel disease
- •Irritable bowel syndrome
- •Acute gastroenteritis
- •Patients who are pregnant
- •Type 1 Diabetes Mellitus
研究组 & 干预措施
Low dose Gluten (0.5g)
Low dose gluten pill
干预措施: Low dose Gluten (Dietary Supplement)
High Dose Gluten (2.0g)
High dose gluten pill
干预措施: High dose Gluten (Dietary Supplement)
Lactose free placebo
Lactose free placebo pill
干预措施: Lactose free placebo (Dietary Supplement)
结局指标
主要结局
Stool gluten immunogenic peptides (GIP) level after administration of gluten compared to baseline level on GFD.
时间窗: 12 weeks
Patient estimated gluten intake after administration of gluten compared to baseline level on GFD, using the Celiac Dietary Adherence Test (CDAT)
时间窗: 12 weeks
Urine gluten immunogenic peptides (GIP) level after administration of gluten compared to baseline level on GFD
时间窗: 12 weeks
NCGS symptoms, using the Celiac Symptom Index (CSI)10 after administration of gluten compared to baseline level on GFD
时间窗: 12 weeks
Patient Estimation of Gluten Intake captured via (PEGI) questionnaire
时间窗: 12 weeks
次要结局
未报告次要终点