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Trial registered on ANZCTR


Registration number
ACTRN12621001090808
Ethics application status
Approved
Date submitted
16/02/2021
Date registered
18/08/2021
Date last updated
18/08/2021
Date data sharing statement initially provided
18/08/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessment of food-specific IgG4 directed elimination diet in eosinophilic oesophagitis
Scientific title
Assessment of food-specific IgG4 directed elimination diet on eosinophil count in adults with eosinophilic oesophagitis
Secondary ID [1] 303481 0
N/A
Universal Trial Number (UTN)
Trial acronym
EoE IgG4
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Eosinophilic Oesophagitis 320799 0
Condition category
Condition code
Oral and Gastrointestinal 318621 318621 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 319771 0
Treatment: Other
Comparator / control treatment
20 patients with other indications for endoscopy and oesophageal biopsies will be the control group.

The 20 control patients will have the baseline interventions performed (endoscopy and biopsies and initial blood test and questionnaire) however there will be no follow-up investigation required. No targeted elimination diet or treatment required unless the control turns out to have undiganosed EoE.
Control group
Active

Outcomes
Primary outcome [1] 326577 0
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.
Timepoint [1] 326577 0
Outcome is assessed within 72 hours of repeat Endoscopic Ultrasound following conclusion of 6 weeks of respective elimination diet.
Secondary outcome [1] 391945 0
Comparison between proportion of responders to FS-IgG4 elimination diet versus proportion of responders to medical therapy or 6FED.
This will be assessed via audit of study database.
Timepoint [1] 391945 0
Audit of study database for this proportion outcome will be calculated at the conclusion of the study.
Secondary outcome [2] 391946 0
Comparison of food-specific IgG4 levels between control patients and patients with EoE.
These will be assessed via blood and serum samples. FS IgG4 will be detected by Nephelometry.
Timepoint [2] 391946 0
Each participant will be assessed within 72 hours of repeat Endoscopic Ultrasound following conclusion of 6 weeks of respective elimination diet.
Secondary outcome [3] 397671 0
Comparison of total IgG4 levels between control patients and patients with EoE.
These will be assessed via blood and serum samples. Total IgG4 will be detected by Nephelometry.
Timepoint [3] 397671 0
Each participant will be assessed within 72 hours of repeat Endoscopic Ultrasound following conclusion of 6 weeks of respective elimination diet.
Secondary outcome [4] 397672 0
Comparison of symptoms between control patients and patients with EoE, using a study-specific symptomatic survey ('EoE_questionnaire_v1.1').
Results are collected from patients at their repeat examination and assessment of EoE.
Timepoint [4] 397672 0
Data between groups will be compared at the conclusion of the study.

Eligibility
Key inclusion criteria
EoE diagnosed based on current guidelines: symptoms of oesophageal dysfunction and greater than/equal to 15 eosinophils/high powered field (hpf).
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/08/2021
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 307898 0
Hospital
Name [1] 307898 0
Royal Adelaide Hospital
Country [1] 307898 0
Australia
Primary sponsor type
Hospital
Name
Royal Adelaide Hospital
Address
Port Road, Adelaide, SA 5000
Country
Australia
Secondary sponsor category [1] 308613 0
None
Name [1] 308613 0
Address [1] 308613 0
Country [1] 308613 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307896 0
Royal Adelaide Hospital Human Research Ethics Committee
Ethics committee address [1] 307896 0
Ethics committee country [1] 307896 0
Australia
Date submitted for ethics approval [1] 307896 0
Approval date [1] 307896 0
31/08/2020
Ethics approval number [1] 307896 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 108858 0
Dr Amanda Lim
Address 108858 0
Department of Gastroenterology, Royal Adelaide Hospital, Port Road, Adelaide, SA 5000
Country 108858 0
Australia
Phone 108858 0
+61 403613966
Fax 108858 0
+61 8 7074 6192
Email 108858 0
amanda.lim@sa.gov.au
Contact person for public queries
Name 108859 0
Romina Safaeian
Address 108859 0
Department of Gastroenterology, Royal Adelaide Hospital, Port Road, Adelaide, SA 5000
Country 108859 0
Australia
Phone 108859 0
+61 8 7074 2189
Fax 108859 0
+61 8 7074 6192
Email 108859 0
romina.safaeian@sa.gov.au
Contact person for scientific queries
Name 108860 0
Romina Safaeian
Address 108860 0
Department of Gastroenterology, Royal Adelaide Hospital, Port Road, Adelaide, SA 5000
Country 108860 0
Australia
Phone 108860 0
+61 8 7074 2189
Fax 108860 0
+61 8 7074 6192
Email 108860 0
romina.safaeian@sa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Ethics approval was not obtained to make IPD available. Individual information will be de-identified and will not be disclosed to the public.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.