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

Assessment of food-specific IgG4 directed elimination diet on eosinophil count in adults with eosinophilic oesophagitis

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621001090808
Acronym
EoE IgG4
Enrollment
50
Registered
2021-08-18
Start date
2021-08-31
Completion date
Unknown
Last updated
2021-08-24

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

Conditions

None listed

Brief summary

Eosinophilic oesophagitis is a chronic allergic, inflammatory disorder that leads to oesophageal dysfunction. The underlying eosinophilic inflammation seen on biopsy manifests itself clinically with symptoms such as dysphagia (difficulty swallowing), food impaction and heartburn. The mainstays of therapy include both pharmacological and dietary modifications. Elimination diets involve patients empirically eliminating all common allergens with gradual re-introduction and reassessment to then identify the offending food antigen(s). Although studies have demonstrated the efficacy of elimination diets in EoE, the high level of dietary restriction, duration of intensive follow-up and requirement for multiple endoscopies limits patient participation. Consequently, finding a process to identify the offending food allergens for a targeted elimination diet would be beneficial. The purpose of this study is to test the effectiveness of using food-specific IgG4 (FS-IgG4) to direct a targeted elimination diet in patients with eosinophilic oesophagitis. The effectiveness will be determined by clinical assessment with a symptom survey, as well as histological improvement (via endoscopy and biopsy).

Interventions

30 Patients with diagnosed with EoE will be recruited through the outpatient clinic, endoscopy unit and motility laboratory; Department of Gastroenterology & Hepatology, Royal Adelaide Hospital. 20 patients with other indications for endoscopy and oesophageal biopsies (eg. Oesophageal reflux, dysphagia) will also be recruited. Study Design: 1. Serum samples from eosinophilic oesophagitis (EoE) patients will be taken for: (a) total IgG4 and IgE levels; (b) specific IgG4 and IgE (sIgG4 and sIgE)

30 Patients with diagnosed with EoE will be recruited through the outpatient clinic, endoscopy unit and motility laboratory; Department of Gastroenterology & Hepatology, Royal Adelaide Hospital. 20 patients with other indications for endoscopy and oesophageal biopsies (eg. Oesophageal reflux, dysphagia) will also be recruited. Study Design: 1. Serum samples from eosinophilic oesophagitis (EoE) patients will be taken for: (a) total IgG4 and IgE levels; (b) specific IgG4 and IgE (sIgG4 and sIgE), and sIgE to milk, wheat, soy, egg white, nut mix (fx1 peanut, hazelnut, almond), seafood mix (fx2 Fish, Shrimp, Blue mussel, Tuna, Salmon); (c) sIgG4 and sIgE to additional foods if suspected on history. 2. Skin Prick Testing (SPT) will be performed to (a) commercial extracts of milk, wheat, soy, egg white, peanut, hazelnut, almond, codfish, shrimp; (b) additional foods if indicated on history (using commercial extracts or fresh/frozen food samples); (c) commercial extracts of common aeroallergens (ryegrass pollen, olive tree pollen, alternaria mould, cat dander, house dust mite) to confirm atopy in those with a history of atopic disease. SPT will be performed and interpreted by an Allergist, Allergy/Immunology advanced trainee, or experienced Allergy Nurse, and in keeping with ASCIA standards outlined in ‘ASCIA Skin prick testing for the diagnosis of allergic disease’ handbook. 3. Comprehensive examination and assessment of EoE including: a) Patients will undergo an upper endoscopy (routine sedative protocol) using an Olympus ‘Gastro-videoscopes’. This will allow assessment of oesophageal mucosa, wall thickness, and tissue acquisition using biopsy forceps through an accessory channel within the endoscope. The duration of the procedure is expected to be approximately 20 minutes. Total IgG4 (T-IgG4), and Food Specific IgG4 (FS-IgG4) will be measured in oesophageal homogenates. b) Baseline bloods including complete blood picture and electrolytes c) Symptomatic survey 4. If FS-IgG4 is detected in baseline serum samples, patients will be offered 6 weeks of elimination of the allergen. Patients will meet a dietitian for education regarding their restricted diet based on IgG4 testing. If dietary contamination occurs, their restricted diet will be extended an additional 6 weeks. 5. Dietitian will undertake an initial nutritional assessment that will include: a) Nutritional status; b) Anthropometric measures including weight, height, Body Mass Index and weight history; c) Diet history; and d) Other factors influencing diet including patient lifestyle, social supports and motivation for dietary compliance. The dietitian will educate the patient on dietary avoidance of identified food(s). The dietitian will review patient dietary compliance after 6 weeks of dietary avoidance and the patient will then undergo a repeat endoscopy before further education. 6. If no FS-IgG4 is detected in baseline serum sample, patients will be offered empirical 6 food elimination diet (6FED) instead under the guidance of a dietitian, administered for 6 weeks. This involves the elimination of 6 of the most common food allergens: milk, wheat, soy, eggs, nuts, and fish. Dietician will also educate the patient on what types of foods to avoid and how to identify foods with allergens, and provide potential food alternatives. Adherence to 6FED will be monitored via food diaries. The dietitian will review patient dietary compliance after 6 weeks. 7. Patients who decline dietary elimination will undertake medical therapy with oral proton-pump inhibitor (PPI), Pantoprazole, and topical corticosteroid, Budesonide. Patient will then have a repeat examination and assessment of EoE: a) EoE endoscopic reference score and biopsy including tissue IgG4 b) Bloods and serum IgG4 c) Symptomatic questionnaire All patients enrolled in the study would like the targeted dietary intervention, but if they do not qualify (no raised FS-IgG4) then they will either have the six-food elimination diet, or 40mg Pantoprazole twice daily (as per guidelines) or Budesonide slurry (1mg/2ml slurry mixed with sucralose). This will occur for 6 weeks before repeat endoscopy to assess for response. Adherence will only be via patient questionnaire, and for the diet, this will be via a diary (with the dietitian). There are no physical or informational materials involved. The dietitian will discuss with patients regarding which foods to be avoided depending on our FS-IgG4 results. If there is histological improvement following dietary restriction, then patients can continue dietary avoidance of this food.

Sponsors

Royal Adelaide Hospital
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026