GlPs Improve Practice (GIP) at Home: Effects of Home Gluten Immunogenic Peptide Testing on Children With Celiac Disease
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Difference in frequency of gluten exposure in open results vs blinded groups following randomization.
研究概览
简要总结
This study aims to investigate how knowledge of gluten immunogenic peptide (GIP) levels in stool and urine affects subsequent adherence to a gluten-free diet. Half of the participants will receive results in real-time using a home device and the other half will store samples to be tested at the end of the 30 week study. Participants will also have a diet review with a dietitian at the beginning of the end of their study and be asked questions about their symptoms, gluten-free diet adherence and quality of life.
详细描述
Following a gluten-free diet is difficult. Eating small amounts of gluten may be common. Gluten may cause a wide range of symptoms, or no symptoms at all. Thus, there is not always a 'feedback loop' to alert to accidental gluten exposure. Nevertheless, these "silent" gluten exposures may interfere with recovery and healing of the intestine. New tools are available to test for fragments of gluten - Gluten Immunogenic Peptides (GIPs) in urine and stool.
The goal of this research study is to evaluate how knowledge of gluten-immunogenic peptide (GIP) levels in urine and stool affects subsequent adherence to a gluten-free diet. Participants will be children with celiac disease recruited at Boston Children's Hospital. All participants will undergo a diet assessment by a dietitian at the beginning and end of the study. At random intervals, participants will be prompted to collect their next urine sample and complete a survey related to symptoms and diet adherence. Half of the participants will store the sample to be tested later and the rest of the participants will be provided with devices to test their urine at home to receive immediate results. Participants in the home testing group will also be given a set of stool tests (x4) to use at their own discretion during the study period, and will report results and reasons for test use to the research team. GIP test results will be compared to other measures of celiac disease and gluten-free diet adherence, including antibody tests. These findings will help to determine how these new tools can be used to improve gluten-free diet adherence and symptoms and the effect on quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 6 to 18 years at study entry
- •Diagnosis of celiac disease based upon either
- •Biopsy criteria i) Marsh 3 lesion and/or villous height:crypt depth ratio (Vh:Cd) < 3 with intraepithelial lymphocytosis; and ii) Elevated serum tTG IgA and/or EMA antibodies
- •Serologic/genetic (ESPGHAN 2012) criteria i) Symptoms compatible with celiac disease; ii) Serum tTG IgA > 10 x upper limit of normal for assay; iii) EMA titre elevated on a separate sample; and iv) HLADQ genotype compatible with celiac disease.
- •Adherence to a gluten-restricted diet (self-reported) for 6 months or more
- •Attending a clinician assessment for celiac disease at Boston Children's Hospital
排除标准
- •Unable to provide urine and/or stool sample or attend study visits
- •English proficiency unsuitable for completion of surveys
- •Anuria or oliguria
- •Reliance upon commercial gluten-free formulas as primary source of nutrition
- •Comorbid condition that in the opinion of the investigator would interfere with the subject's participation in the study or would confound the results of the study
结局指标
主要结局
Difference in frequency of gluten exposure in open results vs blinded groups following randomization.
时间窗: Weeks 8 to 30
Gluten exposure frequency is defined as the average per individual subject post-randomization percentage of samples collected between weeks 8 and 30 with detectable gluten immunogenic peptides using the qualitative assay (Gluten Detective)
次要结局
- Change in celiac disease specific quality of life as measured by Celiac Disease DUX (CDDUX) in blinded vs. open results groups(weeks 8 and 30)
- Change in pediatric health related quality of life as measured by PedsQL 4.0 generic core scale in blinded vs. open results groups(weeks 8 and 30)
- Celiac disease symptom score in blinded vs. open results group at the end of the study(Week 30)
- Difference in quantity of mean gluten exposure following randomization in blinded vs. open results groups(weeks 8 - 30)
- Change in symptom score in blinded vs. open results group(weeks 8 and 30)
研究者
Jocelyn Silvester
Instructor
Boston Children's Hospital