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Developing new tests to monitor patients with eosinophilic oesophagitis using capsule sponge instead of endoscopy

Quantitative biomarker identification for eosinophilic oesophagitis in non-endoscopic capsule sponge cell samples for monitoring treatment efficacy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN14071734
Enrollment
200
Registered
2024-02-23
Start date
2024-02-01
Completion date
Unknown
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eosinophilic oesophagitis (EoE) Digestive System

Interventions

Patients will be asked to undergo a capsule sponge test prior to a standard endoscopy with biopsy

Sponsors

Cyted Ltd
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Over 18 years old with a histologically confirmed diagnosis of EoE 2. Male or Female 3. Newly diagnosed patients with EoE or known existing non-stenotic EoE patients who are on maintenance treatments (i.e., orodispersible budesonide, PPI, biologics, or dietary therapy) and monitoring 4. Patients currently enrolled in the CoSIE study (IRAS 314770) may be retrospectively included with consent

Exclusion criteria

Exclusion criteria: 1. Age =3

Design outcomes

Primary

MeasureTime frame
1. Eosinophil count in biopsy vs sponge pathology (number of eosinophils per high power field - standard measures in diagnosis) at time of procedure and for the sub-group at follow-up 8-12 weeks later 2. Biomarker quantification using ELISA assays for selected biomarkers at time of procedure and for the sub-group at follow-up 8-12 weeks later 3. Severity of symptoms measured using the Dysphagia Symptom Questionnaire (DSQ) at time of procedure and for the sub-group at follow-up 8-12 weeks later

Secondary

MeasureTime frame
Patient satisfaction measured using survey at time of procedure and for the sub-group at follow-up 8-12 weeks later

Countries

England, United Kingdom

Contacts

Public ContactSamantha Roberts
samantha.roberts@cyted.ai+44 (0)1480 453 437

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 7, 2026