Eosinophilic esophagitis (EoE) and eosinophilic gastritis and/or gastroenteritis (EG/EGE) are rare allergic inflammatory disorders that cause chronic gastrointestinal symptoms. Symptoms are often precipitated by certain foods. Current treatments include allergen elimination diets and elemental formula diets. Because of these food restrictions, patients with EoE and/or EG/EGE may worry about what they can eat and how they can participate in social gatherings. We aimed to assess patients’ experience of living with EoE and EG/EGE, with a particular focus on food-related behaviors and anxieties. Conducting this research within clinical trials allows us to examine how patients’ experiences vary over time and between treatment groups.

Exploratory qualitative interviews are included in the ongoing phase 3, randomized, double-blind, placebo-controlled MESSINA (EoE; NCT04543409) and HUDSON (EG/EGE; EudraCT: 2021-000085-14) clinical trials. Consenting adult patients (up to 30 in MESSINA and up to 45 in HUDSON) will participate in telephone interviews at three time points (baseline, open label, and open label extension). Recruitment will be open in Canada, Spain, and the US (both studies); Australia and Brazil (HUDSON); and the UK (MESSINA). The interviews follow discussion guides consisting of open-ended questions about symptoms and their health-related quality of life impacts. Specific questions on food-related behaviors and anxieties are included.

The interviews will be transcribed, translated to English (if necessary), coded for themes, and analyzed using grounded theory-based approaches. The interview data will be complemented by clinical and demographic data from the trials. The analysis will describe patients’ experiences with food and food-related situations, and assess whether these experiences change over time. If found, variations in experiences between groups of patients will be noted. 

The interviews will allow patients to articulate how their relationship with food may have changed during study treatment. The data will contextualize the results of the MESSINA and HUDSON trials by capturing aspects of the patient experience that are not adequately measured using standardized questionnaires and other clinical endpoints. Findings from the interviews may inform both healthcare providers and patients about the relationship between treatments, food restrictions, and food-related psychosocial effects.