Using a capsule sponge to assess treatment response in eosinophilic esophagitis
A Pragmatic Interventional Study to Assess the Clinical Value of Capsule Sponge in the Assessment of Response to Treatment of Non-stenotic Eosinophilic Oesophagitis in a Single District General Hospital
This study is testing a new capsule sponge method to see if it can safely and easily check how well treatment is working for adults with eosinophilic esophagitis, instead of using the usual endoscopy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | East and North Hertfordshire NHS Trust Government |
| Locations | 1 site (Stevenage, Hertfordshire) |
| Trial ID | NCT06501274 on ClinicalTrials.gov |
What this trial studies
This study evaluates the clinical value of a capsule sponge as a less invasive alternative to gastroscopy for assessing treatment response in adult patients with non-stenotic eosinophilic esophagitis. Patients who have not had their esophagus reassessed after a change in treatment will be offered the capsule sponge procedure. The study includes self-administered symptom questionnaires before and after the procedure to gauge patient satisfaction and treatment effectiveness. The aim is to provide a more patient-friendly option for monitoring this condition, especially in light of delays in traditional gastroscopy due to the COVID-19 pandemic.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with non-stenotic eosinophilic esophagitis who have experienced a change in treatment.
Not a fit: Patients with strictures, previous esophageal surgeries, or other significant esophageal conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a more comfortable and accessible method for patients to monitor their eosinophilic esophagitis treatment response.
How similar studies have performed: While the use of capsule endoscopy has been explored in other gastrointestinal conditions, this specific application for eosinophilic esophagitis is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: • patients diagnosed with non -stenotic eosinophilic oesophagitis who have a change in treatment Exclusion Criteria: * Strictures or rings at most recent endoscopy that prevent passage of adult gastroscope * Previous oesophageal dilatation * Previous oesophageal perforation or surgical resection * Oesophago-gastric malignancy * Oesophageal varices * Bolus obstruction since last endoscopy requiring hospital visit * Previous fundoplication or complicated hiatus hernia * Patient on Warfarin with INR\>=3 * Suspected new diagnosis of EOE without prior endoscopic confirmation
Where this trial is running
Stevenage, Hertfordshire
- East and North Herts NHS Trust — Stevenage, Hertfordshire, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Danielle Morris, MD FRCP — East and North Herts NHS Trust
- Study coordinator: Toral Odedra
- Email: toral.odedra@nhs.net
- Phone: 01438 314333
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.