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Trial registered on ANZCTR


Registration number
ACTRN12619000141145
Ethics application status
Approved
Date submitted
18/01/2019
Date registered
30/01/2019
Date last updated
30/01/2019
Date data sharing statement initially provided
30/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Two food group elimination diet versus swallowed fluticasone for the management of adult eosinophilic esophagitis, a single- centred randomised prospective study
Scientific title
Two food group elimination diet versus swallowed fluticasone for the management of adult eosinophilic esophagitis, a single- centred randomised prospective study
Secondary ID [1] 297124 0
None
Universal Trial Number (UTN)
U1111-1226-9318
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
eosinophilic esophagitis 311154 0
Condition category
Condition code
Oral and Gastrointestinal 309778 309778 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 309811 309811 0 0
Allergies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1 ( Swallowed topical steroids ) : fluticasone 500 mcg swallowed twice daily using a metered dose inhaler for 8 weeks.

Arm 2 ( Two food group elimination diet ) : eliminating cow's milk and wheat under the guidance of a gastrointestinal dietitian for 8 weeks.
The consultation is a one off in person ( face to face ) consultation for 45 minutes with a follow up 30 minute phone consultation .
Patient will be provided with education on the elimination process and techniques to ensure diet adequacy through elimination. They will be provided with the resources to guide this process, we are in the process of updating these resources to fit the two food elimination diet .


The adherence to both interventions will be assessed using a compliance diary .
Intervention code [1] 313392 0
Treatment: Drugs
Intervention code [2] 313393 0
Lifestyle
Comparator / control treatment
Arm 1 ( swallowed topical steroids ) will be the control arm .
Control group
Active

Outcomes
Primary outcome [1] 318737 0
To determine the proportion of patients that have responded to each intervention as defined by histological remission.

Histological remission will be defined as reduction of eosinophils to < 15 per HPF on both the distal and proximal oesophageal biopsies.
Timepoint [1] 318737 0
8 weeks
Secondary outcome [1] 365858 0
Comparison of the Dysphagia Symptom Questionnaire between proton pump inhibitor responsive eosinophilia and patients with eosinophilic oesophagitis .
Timepoint [1] 365858 0
8 weeks
Secondary outcome [2] 365859 0
Comparing the differences in eosinophil counts ( using histology , oesophageal biopsies )between the PPI responsive eosinophilia and eosinophilic oesophagitis .
Timepoint [2] 365859 0
8 weeks
Secondary outcome [3] 366156 0
Comparing the differences in serum anti TTG antibodies, ( using standard laboratory blood tests)between the PPI responsive eosinophilia and eosinophilic oesophagitis .
Timepoint [3] 366156 0
8 weeks
Secondary outcome [4] 366157 0
Comparing the differences in Dysphagia Symptom Score between the PPI responsive eosinophilia and eosinophilic oesophagitis .
Timepoint [4] 366157 0
8 weeks
Secondary outcome [5] 366158 0
Comparing the differences in Adult Eosinophilic Esophagitis Quality of Life Questionnaire between the PPI responsive eosinophilia and eosinophilic oesophagitis .
Timepoint [5] 366158 0
8 weeks
Secondary outcome [6] 366159 0
Comparing the differences between swallowed topical fluticasone 500 mcg twice daily for 8 weeks ( Arm 1) and the two food ( cow's milk and wheat ) elimination diet for 8 weeks in Dysphagia Symptom Score
Timepoint [6] 366159 0
8 weeks
Secondary outcome [7] 366160 0
Comparing the differences between swallowed topical fluticasone 500 mcg twice daily for 8 weeks ( Arm 1) and the two food ( cow's milk and wheat ) elimination diet for 8 weeks in Adult Eosinophilic Esophagitis Quality of Life Questionnaire
Timepoint [7] 366160 0
8 weeks
Secondary outcome [8] 366275 0
Comparing the differences in serum IgE levels ( using standard laboratory blood tests)between the PPI responsive eosinophilia and eosinophilic oesophagitis .
Timepoint [8] 366275 0
8 weeks

Eligibility
Key inclusion criteria
Adults over the age of 18 with a diagnosis of eosinophilic esophagitis defined by consensus guidelines (symptoms of oesophageal dysfunction + more than or equal to 15 eosinophils / high powered field on oesophageal biopsies despite 8 weeks of treatment with PPIs to exclude PPI responsive eosinophilia) who were naïve for topical steroid or dietary therapy.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Patients with potential cause for eosinophilia different from eosinophilic esophagitis (e.g. achalasia, caustic or radiation esophagitis, parasites, Inflammatory Bowel Disease, neoplasms and drugs)
• patients with food associated anaphylaxis to milk and wheat
• patients with severe fibro-stricturing eosinophilic esophagitis
• patients in whom esophageal biopsies would be contraindicated (presence of varices or anti coagulation / anti platelets at high risk of thrombotic/ cardio vascular event if withheld)
• Patients who are on oral or inhaled steroids for other indication will be excluded from this study.
• Patients who lack capacity to provide written consent.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis
Potential sample sizes below based on 80% and 90% power with a type 1 error rate of 0.05 (alpha).

Target Actual Power Alpha : 0.80 - 0.0499
Actual Power : 0.80671
N1 : 97
N2 : 97
N : 194
Treatment P1 : 0.6000
Control P2: 0.4000
Diff D1: 0.2000
Target Alpha : 0.0500

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/02/2019
Actual
Date of last participant enrolment
Anticipated
25/01/2021
Actual
Date of last data collection
Anticipated
5/04/2021
Actual
Sample size
Target
194
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 25430 0
4029 - Royal Brisbane Hospital

Funding & Sponsors
Funding source category [1] 301685 0
Hospital
Name [1] 301685 0
Department of Gastroenterology and Hepatology , Royal Brisbane and Women's Hospital
Country [1] 301685 0
Australia
Primary sponsor type
Hospital
Name
Department of Gastroenterology and Hepatology, Royal Brisbane and Women's Hospital
Address
Butterfield St, Herston QLD 4029, Australia
Country
Australia
Secondary sponsor category [1] 301405 0
None
Name [1] 301405 0
Address [1] 301405 0
Country [1] 301405 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302405 0
Royal Brisbane & Women's Hospital Human Research Ethics Committee (RBWH HREC) (EC00172)
Ethics committee address [1] 302405 0
Executive Suites, Lower Ground Floor

Dr James Mayne Building

Royal Brisbane & Women’s Hospital

Herston Qld 4029
Ethics committee country [1] 302405 0
Australia
Date submitted for ethics approval [1] 302405 0
26/11/2018
Approval date [1] 302405 0
15/01/2019
Ethics approval number [1] 302405 0
HREC/2018/QRBW/46020

Summary
Brief summary
Eosinophilic oesophagitis (EoE) is an allergic condition which leads to inflammation of the oesophagus and subsequently difficulty in swallowing and episodes of food material getting stuck in the food pipe requiring urgent medical care. Swallowed steroid medication that coats the oesophagus and special diets that focus on eliminating dietary triggers for this allergic condition are the two modalities of treatment. This study aims to compare the efficacy of these two treatments in our local cohort of patients diagnosed with EoE.
All patients with a suspicion of this condition identified at initial endoscopy will be flagged as potential participants for this study. Gastroenterologist will be informed via email regarding the trial. They will notify potential participants that a trial involving this condition is being conducted at the hospital and ask if the patients are interested. The trial doctor will then contact them and provide an overview of the study and then email information sheets to the patient. At this phone call it will also be confirmed that these patients are on medications that supress acid secretion from stomach, as per standard care.
On the day of repeat endoscopy (Endoscopy 2, to repeat biopsies ), prior to sedation, patients will be approached and if they would like to participate in the trial written consent will be obtained.

Subsequently they will complete questionnaires and receive blood test prior to undergoing endoscopy. These will assess the severity of symptoms and the effects of this condition on these patients' quality of life. Other patient demographics will also be collected on the day. (please see Case Report Form).

The results from the second procedure ( endoscopy ) will be reviewed. If the inflammation has resolved with the acid suppressing mediation ( PPIs) patients do not have eosinophilic oesophagitis and are excluded from continuing in the trial. Patients that have ongoing inflammation despite using acid suppressing medication will be diagnosed with eosinophilic oesophagitis and will be randomly assigned to swallowed topical steroids arm or the food elimination arm.
Patients randomized to the elimination diet arm will be referred to a dietician who will counsel them regarding avoiding cow milks protein and wheat. After 8 weeks of being on this diet, patients will undergo endoscopy (Endoscopy 3). On the day of endoscopy, bloods will be collected and a questionnaire will be completed.
Patients assigned to the swallowed topical arm will be seen in the gastroenterology clinics, counselled regarding the use of the medication and provided with a script. After 8 weeks of swallowed topical steroids, patient will undergo endoscopy (Endoscopy 3) . On the day of endoscopy bloods will be collected and a questionnaire will be completed.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 90126 0
Dr Abdulnasser Lafta
Address 90126 0
Dr Abdulnasser Lafta
Department of Gastroenterology and Hepatology
Level 9, Ned Hanlon Building
Royal Brisbane & Women’s Hospital
Herston Qld 4029
Country 90126 0
Australia
Phone 90126 0
+61 477063803
Fax 90126 0
Email 90126 0
[email protected]
Contact person for public queries
Name 90127 0
Abdulnasser Lafta
Address 90127 0
Dr Abdulnasser Lafta
Department of Gastroenterology and Hepatology
Level 9, Ned Hanlon Building
Royal Brisbane & Women’s Hospital
Herston Qld 4029
Country 90127 0
Australia
Phone 90127 0
+61 736468111
Fax 90127 0
Email 90127 0
[email protected]
Contact person for scientific queries
Name 90128 0
Abdulnasser Lafta
Address 90128 0
Dr Abdulnasser Lafta
Department of Gastroenterology and Hepatology
Level 9, Ned Hanlon Building
Royal Brisbane & Women’s Hospital
Herston Qld 4029
Country 90128 0
Australia
Phone 90128 0
+61 477063803
Fax 90128 0
Email 90128 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
Only researchers who provide a methodologically sound proposal
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Access subject to approvals by Principal Investigator


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1102Ethical approval    376767-(Uploaded-18-01-2019-06-55-27)-Study-related document.pdf



Results publications and other study-related documents

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