Gluten Intolerance in Irritable Bowel Syndrome With Diarrhea: The Role of HLA-DQ2
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Colonic permeability
研究概览
简要总结
The specific hypotheses are:
Gluten supplementation for four weeks increases small intestinal permeability and accelerates colonic transit in patients with irritable bowel syndrome with diarrhea (IBS-D) or functional diarrhea (FD) who are HLA-DQ2 positive.
详细描述
The study design is a double-blind, randomized, controlled, parallel-group, 6-week study comparing the effects of gluten rich versus gluten free diets in diarrhea or diarrhea predominant IBS patients. All participants will keep a daily bowel pattern diary throughout the study. All participants will have negative serum tissue transglutaminase (TTg) assay, and anti-endomysial antibody test, if TTg is positive or equivocal. All participants will have the following studies performed both before and after the 4-week dietary intervention:
- Stool samples to check markers of inflammation such as fecal calprotectin.
- Blood samples to check markers of inflammation and for genetic testing.
- After ingestion of the mannitol, lactulose and sucralose sugars, urine samples to indirectly measure small intestinal and colonic permeability.
- After sedation, upper gastrointestinal endoscopy and flexible sigmoidoscopy to obtain 6 mucosal biopsies from the small bowel and sigmoid colon for immunohistochemical analysis.
- Scintigraphy to measure gastrointestinal transit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diarrhea or diarrhea predominant IBS patients
- •Age 18 to 65
- •BDQ confirms presence of IBS-D or functional diarrhea, positive by Rome III criteria
- •No restrictions on Hospital Anxiety Depression score
- •No abdominal surgery (except appendectomy and cholecystectomy)
排除标准
- •Serum tissue transglutaminase IgA or IgG 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)
- •Use of NSAIDs or aspirin within the past week (since NSAIDs affect intestinal permeability)
- •Use of oral corticosteroids within the previous 6 weeks
- •Ingestion of artificial sweeteners such as SplendaTM (sucralose), Nutrasweet TM(aspartame), lactulose or mannitol 2 days before the study begins, e.g., foods to be avoided are sugarless gums or mints and diet soda
- •Ingestion of any prescription, over the counter, or herbal medications which can affect gastrointestinal transit 7 days before study begins.
- •Any females who are pregnant or trying to become pregnant (due to radiation exposure)
- •Bleeding disorders or medications that increase risk of bleeding from mucosal
研究组 & 干预措施
Gluten free diet
干预措施: Gluten free diet (Other)
Gluten rich diet
干预措施: Gluten rich diet (Other)
结局指标
主要结局
Colonic permeability
时间窗: 2 -24 hours post sugars ingestion
Cumulative excretion of mannitol at 2-24 hours after liquid
Colonic transit
时间窗: 24 hours
Colonic transit geometric center at 24 hours
Small bowel permeability
时间窗: 0 - 2 hours post sugar ingestion
Excretion of mannitol 0-2 hours after liquid formulation
次要结局
- Small bowel transit time(6 hours)
- Colon transit(6-12 hours)
- Colonic permeability(8 to 24 hours after ingestion of sugars)
- Stool frequency and consistency(6 weeks)
- Gastric emptying(0-2 hours)
- Small bowel inflammatory response(4 weeks)
- Colonic inflammatory response(4 weeks)
- Colonic permeability(2-24 hours after sugars ingestion)