Modeling Symptom Severity and Estimated Gluten Ingestion in Celiac Disease Patients on a Gluten-Free Diet

Introduction: It is common for celiac disease (CD) patients on a gluten-free diet to accidentally consume gluten that can cause symptomatic distress and histologic damage. We present an algorithm to relate the quantity of gluten intake to the severity of episodic symptoms for abdominal pain, bloating and tiredness in CD patients. Methods: This analysis employs a model based on data from the CeliAction study for latiglutenase (ALV003-1221; NCT01917630). A previously estimated average daily quantity of gluten consumed by these trial patients along with the data for frequency and severity of the symptoms for abdominal pain, bloating, and tiredness allowed us to estimate the relationship between episodic inadvertent gluten ingestion and symptom severity. Results: The CD trial patients were previously estimated to consume a mean of 354 mg/day. From the study data, these patients experienced at least one symptom (of six possible) almost every day (6.13/week) and on average experienced 2-3 different symptoms per symptom event. The most common severity (on a 1-5 scale) was 2 for abdominal pain and 3 for bloating and tiredness corresponding to 1.1, 0.9, and 0.7 g gluten consumed per event. The frequency that a severe symptom (4 or 5) occurs during a symptomatic event equates to about 10%, 27%, and 33% for abdominal pain, bloating, and tiredness and correlates to 2.1, 1.2, and 1.0 g gluten consumed per event, respectively. Conclusions: This model suggests that the quantity of ingested gluten varies per event type and likely includes periodic gluten exposures of substantial quantity.