Eosinophilic Oesophagitis Assessment With String Testing

NCT06159218 | Unknown

• 2 other identifiers: 2021.0276IRAS
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Eosinophilic oesophagitis (EoE) is an inflammatory condition of the oesophagus (food pipe) that can lead to difficulty swallowing and to food to getting stuck and has become increasingly common over the past 40 years. EoE is triggered by a protein in the diet but alterations to the types of bacteria (microbiome) in the oesophagus may also be involved. EoE is diagnosed with gastroscopy (a thin camera test via the mouth) where 6 tiny samples (biopsies) are taken. Treatment is either with removing food groups from the diet or medications including steroids (budesonide) or a proton pump inhibitor (PPI, omeprazole). The aim is to improve symptoms and to stop scar tissue forming that can cause food to get stuck. Patients with EoE will need to undergo many gastroscopies over their life, which even with sedation can be a daunting experience. There has been research into less invasive tests and two previous studies have shown that a thin swallowed string may be able to detect substances (biomarkers) that indicate how severe the EoE is. These studies were small and it is not known how the biomarkers change with different treatments or how well they relate to symptoms and findings with endoscopy. In this study the investigators will ask adults with EoE to swallow a thin string made of rayon for 30 minutes, with one end taped to the cheek, which the investigators will analyse for biomarkers and bacteria, on the same day as their routine gastroscopy and also perform a symptom survey. The investigators will also take an extra 2 biopsies to analyse the nerves which may explain why some patients have more symptoms than others. The investigators will repeat the string test on their next endoscopy, to assess what the changes have been in response to their treatments. These findings may improve understanding on how to monitor EoE in less invasive ways in future.

Conditions

Eosinophilic Esophagitis

Outcome Measures

Primary Outcomes (3)

• Do eosinophil associated protein (EAP) biomarkers detected with string testing correlate with peak eosinophil count (eos/HPF) on endoscopic mucosal biopsy in adults with eosinophilic oesophagitis (EoE)?

  Measurement of string biomarker levels in comparison to mucosal eosinophil counts

  12 weeks

• How does the oesophageal microbiome, sampled with string testing, change after treatment for EoE?

  Measurement of bacterial abundance (sequences per sample) on string testing

  12 weeks

• How does the density of calcitonin gene related peptide (CGRP) in the oesophageal mucosal biopsy change after treatment for EoE?

  Assessment of change in density of CGRP in mucosa after treatment for EoE

  12 weeks

Secondary Outcomes (2)

• How do EAP detected with string testing change in response to treatments for EoE?

  12 weeks

• How does the oesophageal microbiome, sampled with string testing differ in EoE treatments?

  12 weeeks

Study Arms (2)

Omeprazole

ACTIVE COMPARATOR

Patients with active EoE who have been started on omeprazole as treatment

Device: CEST - coiled oesophageal string test

Budesonide

ACTIVE COMPARATOR

Patients with active EoE who have been started on budesonide as treatment

Device: CEST - coiled oesophageal string test

Interventions

CEST - coiled oesophageal string test DEVICE

All patients will swallow a small string (CEST) which will be removed and then analysed for biomarkers and microbiome.

Budesonide; Omeprazole

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient under the care of St George's University Hospital NHS Foundation Trust, London
• Diagnosis of EoE as defined by endoscopy with mucosal biopsy showing \>15 eos/HPF
• Male or Female
• Age 18 to 90

You may not qualify if:

• Patients \< 18 years old or \>90 years old
• Patients with significant medical co-morbidities
• Patients unable to provide consent for study participation
• Patients who have had complications from their endoscopy or EoE treatment
• Patients who have previously undergone oesophageal surgery

Sponsors & Collaborators

• St George's, University of London: lead
• University Hospital Southampton NHS Foundation Trust: collaborator
• St George's University Hospitals NHS Foundation Trust: collaborator

Study Sites (1)

St Georges University Hospitals NHS Foundation Trust

London, SW17 0RE, United Kingdom

RECRUITING

MeSH Terms

Conditions

Eosinophilic Esophagitis

Condition Hierarchy (Ancestors)

Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Adult patients with Eosinophilic Oesophagitis will undergo a swallowed string test just prior to their scheduled endoscopy. No additional endoscopy will be requested than as per routine care. String test will be analysed for biomarkers and the microbiome to compare against disease severity and medical therapy.

Study Record Dates

• First Submitted: November 24, 2022
• First Posted: December 6, 2023
• Study Start: November 9, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: December 6, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)