A Pilot Study Barrier Function, Intestinal Permeability and Tight Junction Expression in Gluten Sensitive Patients With Functional Gastrointestinal Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in permeability of the small intestine after treatment
研究概览
简要总结
The overall hypothesis of this research study is that gluten intake alters intestinal barrier function in patients with Irritable Bowel Syndrome (IBS) diarrhea who also exhibit non-celiac gluten sensitivity (NCGS).
详细描述
The specific aim of this hypothesis-generating, pilot study is to randomize (like the flip of a coin) patients who have Non Celiac Gluten Sensitivity to a 4-week Gluten-containing diet (GCD) or to a Gluten free diet (GFD). The study will evaluate small bowel (SB) permeability functionally (2-sugar differential excretion), morphologically, using probe-based confocal laser to evaluate the small intestinal, as well as molecularly, using tight junction (TJ) messenger RNA (mRNA) expression in small bowel mucosa in response to the different diets.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Non celiac gluten sensitive patients with a functional bowel disorder
- •Age 18 to 70 years.
排除标准
- •Positive serum tissue transglutaminase (TTG) Immunoglobulin A (IgA) positive or medical record of small bowel biopsy suggestive of celiac disease.
- •Use of tobacco products within the past 6 months (since nicotine may affect intestinal permeability).
- •Abdominal surgeries (except appendectomy, cholecystectomy and vaginal hysterectomy or tubal ligation)
- •Use of Nonsteroidal Anti-inflammatory Drugs(NSAIDs) or aspirin within the past week (since Nonsteroidal Anti-inflammatory Drugs (NSAIDs) affect intestinal permeability).
- •Use of oral corticosteroids within the previous 6 weeks.
- •Ingestion of artificial sweeteners such as Sucralose, Nutrasweet ™ (aspartame), lactulose or mannitol 2 days before the study tests begins, e.g., foods to be avoided are sugarless gums or mints and diet soda.
- •Bleeding disorders or medications that increase risk of bleeding from mucosal biopsies.
- •High anxiety or depression score (>11 on each subscale) on the Hospital Anxiety Depression Score questionnaire.
- •Known allergy to fluorescein.
研究组 & 干预措施
Gluten
A total of 24 patients with NCGS and 12 healthy controls will be recruited for this study. The 24 patients with NCGS will be randomized to receive one of two diets (GFD or GCD) in a 1:1 ratio
干预措施: Gluten Healthy (Dietary Supplement)
Placebo
A total of 24 patients with NCGS and 12 healthy controls will be recruited for this study. The 24 patients with NCGS will be randomized to receive one of two diets (GFD or GCD) in a 1:1 ratio
干预措施: Placebo (Drug)
结局指标
主要结局
Change in permeability of the small intestine after treatment
时间窗: Baseline to 4 weeks
次要结局
未报告次要终点