Assessment of Symptom Patterns in Celiac Disease: A Prospective Longitudinal Survey
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 480
- 试验地点
- 1
- 主要终点
- Number of Participants With Each Gastrointestinal Symptom and Tiredness Assessed by the Celiac Disease Symptom Diary (CDSD)
研究概览
简要总结
The goal of this study is to better understand the symptoms and impacts of celiac disease (CeD). Participants use a smart phone online app to answer daily questionnaires about symptoms and life with CeD for 12 weeks. There are no blood draws, gluten challenges, medications, or doctor visits required.
详细描述
This is an observational, prospective study to measure symptoms and impacts of CeD.
This study will assess CeD symptom patterns over a 3-month observation period. The study will enroll approximately 400 participants.
The data will be prospectively collected, via a self-reported ePRO platform accessible by smartphone.
This virtual study will be conducted in the United States.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 12 years of age or older.
- •Diagnosed with CeD for at least 1 year.
- •For participants diagnosed over the age of 18: Biopsy confirmed diagnosis with CeD (participant reported).
- •For participants diagnosed under the age of 18: Blood test or biopsy confirmed diagnosis with CeD (participant reported).
- •Currently following a gluten free diet (GFD) for at least 6 months.
- •Has experienced symptoms believed by the participant to be CeD related in the last 3 months.
- •Has daily access to a smartphone as well as internet/Wi-Fi/cellular data.
- •Speaks and reads English.
- •Lives in the US (participant reported).
排除标准
- •Currently involved or planning to be involved in any clinical studies with an investigational drug, surgical procedure, or gluten challenge over the 3-month observation period.
结局指标
主要结局
Number of Participants With Each Gastrointestinal Symptom and Tiredness Assessed by the Celiac Disease Symptom Diary (CDSD)
时间窗: Up to 12 weeks
The CDSD is a celiac specific symptom assessment tool administered daily. The symptoms measured will include diarrhea, abdominal pain, bloating, nausea/vomiting, number of bowel movements and tiredness. Presence and count of each symptom will be reported for the overall sample as well as separately for adults (age greater than or equal to \[\>=\] 18) and adolescents (age \>=12 less than \[\<\] 18).
Number of Participants With Presence of Non-gastrointestinal (GI) Symptoms
时间窗: Up to 12 weeks
Non-GI symptoms include: Headache, Brain fog (feeling confused or disorganized, or finding it hard to put thoughts into words), Dermatitis herpetiformis (DH) or other rash (suspected to be related to gluten exposure), Joint/body pain (suspected to be related to gluten exposure), Irritability (feeling easily upset or frustrated), Mouth sores/canker sores, and others. Presence/count of each symptom will be assessed overall and separately for adults (age \>=18) and adolescents (age \>=12 and \<18).
次要结局
- Work Productivity Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire(Up to 12 weeks)
- Number of Participants With Presence/Absence of Known and Suspected Gluten Exposure(Up to 12 weeks)
- Quality of Life (QoL) as Measured by the 12-Item Short Form Survey (SF-12) Version 2 (v2)(Up to 12 weeks)
- Number of Participants With Healthcare Resource Utilization (HCRU)(Up to 12 weeks)