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.
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.
Study Type
OBSERVATIONAL
Enrollment
480
This is a non-interventional study.
Takeda
Lexington, Massachusetts, United States
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).
Time frame: 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).
Time frame: Up to 12 weeks
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).
Time frame: 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).
Time frame: Up to 12 weeks
Number of Participants With Healthcare Resource Utilization (HCRU)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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).
Time frame: 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).
Time frame: Up to 12 weeks