A Prospective Trial of Celiac Disease Screening
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- change in health related quality of life
研究概览
简要总结
The purpose of this study is to see if it makes sense to test people for celiac disease who have a first or second degree relative (parent, sibling, child, grandparent, aunt or uncle) with celiac disease. The investigators will check to see what differences there are in the health and quality of life between those who know they have celiac disease and start the gluten free diet and those who do not.
详细描述
Our overall hypothesis is that first and second degree relatives of individuals with celiac disease benefit from screening and diagnosis of celiac disease. Secondary hypotheses are:
- The number needed to test and cost to benefit one person though celiac disease screening are within acceptable ranges of 33 tested and < $10,000 spent.
- Treatment does not lead to adverse metabolic changes.
- Intestinal biopsy is unnecessary for accurate diagnosis in a substantial subset of adults.
Aim 1. Determine the effect of screen detected celiac disease on health related quality of life.
- Evaluate change in health related quality of life at one year in participants randomized to the screen detected, early diagnosis cohort compared to the screen detected, delayed diagnosis, clinically detected and non-celiac control cohorts.
- Evaluate change in symptoms, psychological well-being and burden of treatment at one year in the screen detected, early diagnosis cohort compared to the screen detected, delayed diagnosis, clinically detected and non-celiac control cohorts.
- Evaluate the cost per diagnosis and the number needed to test for the diagnosis of individuals who will have a clinically meaningful improvement in health related quality of life attributable to treatment of celiac disease.
Aim 2: Assess the effect of screen detected celiac disease on nutritional and metabolic indices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 否
入选标准
- •Be ambulatory, community dwelling, 18 to 80 years, inclusive
- •For the screening cohort:
- •Have a first or second degree family member with known biopsy-proven celiac disease.
- •Have not been on a gluten-free diet in the past 6 months
- •Have not received a prior diagnosis of celiac disease at any time
- •For the clinically detected cohort
- •Have biopsy proven celiac disease detected based on clinical symptoms and on a gluten free diet for less than 1 month.
排除标准
- •For the screen detected cohort, have significantly severe symptoms (as judged by the investigator) at screening which preclude randomization;
- •Be on a gluten-free diet or have been on a gluten-free diet within the past 6 months.
- •Be pregnant or planning pregnancy in the study time period
- •Be taking corticosteroids or immunomodulators
- •Have a history of significant concomitant gastrointestinal disease or other comorbidity judged by the investigator to potentially interfere with study outcomes
- •Be unable or unwilling to cooperate with the study protocol
- •Have insufficient knowledge of English to complete study surveys
研究组 & 干预措施
screen detected, early diagnosis cohort
Subjects will be informed they have celiac disease and will be started on the gluten free diet.
干预措施: gluten free diet (Other)
screen detected, delayed diagnosis cohort
Subjects will not be told they have celiac disease and will not start the gluten free diet.
结局指标
主要结局
change in health related quality of life
时间窗: Baseline, 3, 6, 9 and 12 months
as measured by the EQ-5D
次要结局
- change in celiac symptoms(Baseline, 3, 6, 9 and 12 months)
- change in bone density(Baseline and 12 months)
- change in psychological well-being(Baseline, 3, 6, 9, and 12 months)
- change in burden of treatment(baseline, 3, 6, 9, and 12 months)
研究者
Daniel Leffler
Associate Professor of Medicine
Beth Israel Deaconess Medical Center