Two food group elimination diet versus swallowed fluticasone for the management of adult eosinophilic esophagitis, a single- centred randomised prospective study
Department of Gastroenterology and Hepatology, Royal Brisbane and Women's Hospital
194 participants
Feb 4, 2019
Interventional
Conditions
Summary
Eosinophilic oesophagitis (EoE) is an allergic condition which leads to inflammation of the oesophagus and subsequently difficulty in swallowing and episodes of food material getting stuck in the food pipe requiring urgent medical care. Swallowed steroid medication that coats the oesophagus and special diets that focus on eliminating dietary triggers for this allergic condition are the two modalities of treatment. This study aims to compare the efficacy of these two treatments in our local cohort of patients diagnosed with EoE. All patients with a suspicion of this condition identified at initial endoscopy will be flagged as potential participants for this study. Gastroenterologist will be informed via email regarding the trial. They will notify potential participants that a trial involving this condition is being conducted at the hospital and ask if the patients are interested. The trial doctor will then contact them and provide an overview of the study and then email information sheets to the patient. At this phone call it will also be confirmed that these patients are on medications that supress acid secretion from stomach, as per standard care. On the day of repeat endoscopy (Endoscopy 2, to repeat biopsies ), prior to sedation, patients will be approached and if they would like to participate in the trial written consent will be obtained. Subsequently they will complete questionnaires and receive blood test prior to undergoing endoscopy. These will assess the severity of symptoms and the effects of this condition on these patients' quality of life. Other patient demographics will also be collected on the day. (please see Case Report Form). The results from the second procedure ( endoscopy ) will be reviewed. If the inflammation has resolved with the acid suppressing mediation ( PPIs) patients do not have eosinophilic oesophagitis and are excluded from continuing in the trial. Patients that have ongoing inflammation despite using acid suppressing medication will be diagnosed with eosinophilic oesophagitis and will be randomly assigned to swallowed topical steroids arm or the food elimination arm. Patients randomized to the elimination diet arm will be referred to a dietician who will counsel them regarding avoiding cow milks protein and wheat. After 8 weeks of being on this diet, patients will undergo endoscopy (Endoscopy 3). On the day of endoscopy, bloods will be collected and a questionnaire will be completed. Patients assigned to the swallowed topical arm will be seen in the gastroenterology clinics, counselled regarding the use of the medication and provided with a script. After 8 weeks of swallowed topical steroids, patient will undergo endoscopy (Endoscopy 3) . On the day of endoscopy bloods will be collected and a questionnaire will be completed.
Eligibility
Inclusion Criteria1
- Adults over the age of 18 with a diagnosis of eosinophilic esophagitis defined by consensus guidelines (symptoms of oesophageal dysfunction + more than or equal to 15 eosinophils / high powered field on oesophageal biopsies despite 8 weeks of treatment with PPIs to exclude PPI responsive eosinophilia) who were naïve for topical steroid or dietary therapy.
Exclusion Criteria6
- Patients with potential cause for eosinophilia different from eosinophilic esophagitis (e.g. achalasia, caustic or radiation esophagitis, parasites, Inflammatory Bowel Disease, neoplasms and drugs)
- patients with food associated anaphylaxis to milk and wheat
- patients with severe fibro-stricturing eosinophilic esophagitis
- patients in whom esophageal biopsies would be contraindicated (presence of varices or anti coagulation / anti platelets at high risk of thrombotic/ cardio vascular event if withheld)
- Patients who are on oral or inhaled steroids for other indication will be excluded from this study.
- Patients who lack capacity to provide written consent.
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Interventions
Arm 1 ( Swallowed topical steroids ) : fluticasone 500 mcg swallowed twice daily using a metered dose inhaler for 8 weeks. Arm 2 ( Two food group elimination diet ) : eliminating cow's milk and wheat under the guidance of a gastrointestinal dietitian for 8 weeks. The consultation is a one off in person ( face to face ) consultation for 45 minutes with a follow up 30 minute phone consultation . Patient will be provided with education on the elimination process and techniques to ensure diet adequacy through elimination. They will be provided with the resources to guide this process, we are in the process of updating these resources to fit the two food elimination diet . The adherence to both interventions will be assessed using a compliance diary .
Locations(1)
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ACTRN12619000141145