For people living with celiac disease, symptoms such as abdominal pain, bloating, diarrhea, nausea, and fatigue can persist even when they are carefully following a gluten free diet. These ongoing symptoms highlight an important reality: while the gluten-free diet is currently the only available treatment for celiac disease, it does not fully address the needs of everyone in the community. As new therapies for celiac disease are being developed, reliable tools are required to measure whether those treatments meaningfully improve symptoms.
To help meet that need, the Celiac Disease Foundation partnered with Takeda Pharmaceuticals to support validation of a standardized daily symptom diary designed specifically for use in clinical trials. In a recently published study, Psychometric Evaluation of the Celiac Disease Symptom Diary 2.1© Using Data from the Virtual Celiac Symptoms Study, researchers evaluated the performance of the Celiac Disease Symptom Diary 2.1© (CDSD 2.1) as a patient reported outcome measure for use in clinical trials.
A total of 480 participants enrolled in this study, including 338 adults and 142 adolescents. Participants recorded their symptoms daily using a smartphone application. The study demonstrated that the CDSD 2.1 shows strong reliability and validity and is responsive to changes in symptom severity over time, supporting its use as a standardized tool in interventional research.
“Validated symptom measurement tools are required in clinical trials to generate data that meets regulatory standards set by agencies such as the U.S. Food and Drug Administration,” said Marilyn Geller, Chief Executive Officer of the Celiac Disease Foundation. “Future pharmaceutical treatments for celiac disease must demonstrate that they improve outcomes that matter to patients, which is why the Foundation partnered with Takeda Pharmaceuticals on development of this important tool.”
The study was led by Takeda Pharmaceuticals, with the Celiac Disease Foundation serving as the primary patient recruitment and engagement partner. The Foundation recruited participants through digital outreach, supported study participation throughout the 12-week period, and helped ensure strong retention and quality data. The validated CDSD 2.1 is now being used in ongoing trials to further evaluate its performance.
By establishing a scientifically supported tool to measure symptom change, this work strengthens the foundation for future therapy development in celiac disease. Reliable patient reported outcome measures are essential for advancing clinical research and ensuring that new treatments are evaluated based on outcomes that reflect the patient experience. Foundation-led related research initiatives continue to expand opportunities for patient participation in future clinical trials. If you are interested in helping advance research, we invite you to explore the following opportunities: