Virtual Celiac Symptoms Study in Adults and Teenagers

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Assessment of Symptom Patterns in Celiac Disease: A Prospective Longitudinal Survey

Conditions
-----------------
Celiac Disease

Intervention / Treatment
-----------------
* Other: No Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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). Exclusion Criteria: 1. 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.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants with CeD<br>Participants diagnosed with CeD will be observed prospectively for CeD symptom patterns over a 3-month period. | Other: No Intervention<br>* This is a non-interventional study.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Each Gastrointestinal Symptom and Tiredness Assessed by the Celiac Disease Symptom Diary (CDSD) | 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). | Up to 12 weeks | 
| Number of Participants With Presence of Non-gastrointestinal (GI) Symptoms | 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). | Up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Presence/Absence of Known and Suspected Gluten Exposure | This will be assessed overall and separately for adults (age >=18) and adolescents (age >=12 and <18). | Up to 12 weeks | 
| Quality of Life (QoL) as Measured by the 12-Item Short Form Survey (SF-12) Version 2 (v2) | QoL will be measured using SF-12v2. SF-12 is a 12-item self-report that assesses the impact of health on an individual's everyday life. Average SF-12 scores will be reported for the overall sample as well as separately for adults (age >=18) and adolescents (age >=12 and <18). | Up to 12 weeks | 
| Number of Participants With Healthcare Resource Utilization (HCRU) | Participants reporting the number of hospitalizations, emergency room (ER) visits, and outpatient/urgent care visits they had in the previous week. HCRU will be reported for the overall sample as well as separately for adults (age >=18) and adolescents (age >=12 and <18). | Up to 12 weeks | 
| Work Productivity Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire | WPAI measures the effect of general health and symptom severity on work/schoolwork productivity and regular activities during the past seven days. Average WPAI scores will be reported for the overall sample as well as separately for adults (age >=18) and adolescents (age >=12 and <18). | Up to 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Celiac Disease, Signs and Symptoms, Digestive, Quality of Life, Diet, Gluten-Free