Assessment of food-specific IgG4 directed elimination diet in eosinophilic oesophagitis

Not Applicable

• Conditions: Eosinophilic Oesophagitis; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12621001090808
• Lead Sponsor: Royal Adelaide Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-18
• Last Update Posted: 24 August 2021

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

EoE diagnosed based on current guidelines: symptoms of oesophageal dysfunction and greater than/equal to 15 eosinophils/high powered field (hpf).

Exclusion Criteria

1) History of severe respiratory, cardiovascular, hepatic and/or renal disease, chronic alcohol abuse or epilepsy (excluded by history);
2) Medication that may influence gastrointestinal function;
3) Anti-coagulation therapy (NB: warfarin may be ceased for up to 7 days prior to procedure at the discretion of both cardiologist and gastroenterologist);
4) Antihistamine use (Anti-histamines must be held 7 days prior to skin prick testing);
5) Gastrointestinal surgery (hernia repair);
6) Known history of major psychiatric disorders (meets DSM V criteria);
7) Female patients not using appropriate contraceptive method (i.e. oral contraceptive pill, diaphragm, Depo-Provera hormonal contraceptive injection, intrauterine device, Norplant method);
8) Pregnant and/or breastfeeding mothers;
9) Unable to give written informed consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the effectiveness of food-specific IgG4 led elimination diet. Response is defined as either <15 eosinophils per High Powered Field (HPF) or >50% reduction in oesophageal eosinophilic count. These will be assessed from oesophageal mucosal biopsies via Endoscopic Ultrasound.[Outcome is assessed within 72 hours of repeat Endoscopic Ultrasound following conclusion of 6 weeks of respective elimination diet.]