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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]

None

Universal Trial Number (UTN)

U1111-1226-9318

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

eosinophilic esophagitis

Condition category

Condition code

Oral and Gastrointestinal

Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Inflammatory and Immune System

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]

Treatment: Drugs

Intervention code [2]

Lifestyle

Comparator / control treatment

Arm 1 ( swallowed topical steroids ) will be the control arm .

Control group

Active

Outcomes

Primary outcome [1]

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]

8 weeks

Secondary outcome [1]

Comparison of the Dysphagia Symptom Questionnaire between proton pump inhibitor responsive eosinophilia and patients with eosinophilic oesophagitis .

Timepoint [1]

8 weeks

Secondary outcome [2]

Comparing the differences in eosinophil counts ( using histology , oesophageal biopsies )between the PPI responsive eosinophilia and eosinophilic oesophagitis .

Timepoint [2]

8 weeks

Secondary outcome [3]

Comparing the differences in serum anti TTG antibodies, ( using standard laboratory blood tests)between the PPI responsive eosinophilia and eosinophilic oesophagitis .

Timepoint [3]

8 weeks

Secondary outcome [4]

Comparing the differences in Dysphagia Symptom Score between the PPI responsive eosinophilia and eosinophilic oesophagitis .

Timepoint [4]

8 weeks

Secondary outcome [5]

Comparing the differences in Adult Eosinophilic Esophagitis Quality of Life Questionnaire between the PPI responsive eosinophilia and eosinophilic oesophagitis .

Timepoint [5]

8 weeks

Secondary outcome [6]

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]

8 weeks

Secondary outcome [7]

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]

8 weeks

Secondary outcome [8]

Comparing the differences in serum IgE levels ( using standard laboratory blood tests)between the PPI responsive eosinophilia and eosinophilic oesophagitis .

Timepoint [8]

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?

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]

4029 - Royal Brisbane Hospital

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Department of Gastroenterology and Hepatology , Royal Brisbane and Women's Hospital

Address [1]

Department of Gastroenterology and Hepatology
Royal Brisbane and Women's Hospital
Butterfield Street, Herston Queensland 4029

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Brisbane & Women's Hospital Human Research Ethics Committee (RBWH HREC) (EC00172)

Ethics committee address [1]

Executive Suites, Lower Ground Floor

Dr James Mayne Building

Royal Brisbane & Women’s Hospital

Herston     Qld        4029

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

26/11/2018

Approval date [1]

15/01/2019

Ethics approval number [1]

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

Dr Abdulnasser Lafta

Address

Dr Abdulnasser Lafta
Department of Gastroenterology and Hepatology
Level 9, Ned Hanlon Building
Royal Brisbane & Women’s Hospital
Herston Qld 4029

Country

Australia

Phone

+61 477063803

Fax

[email protected]

Contact person for public queries

Name

Abdulnasser Lafta

Address

Dr Abdulnasser Lafta
Department of Gastroenterology and Hepatology
Level 9, Ned Hanlon Building
Royal Brisbane & Women’s Hospital
Herston Qld 4029

Country

Australia

Phone

+61 736468111

Fax

[email protected]

Contact person for scientific queries

Name

Abdulnasser Lafta

Address

Dr Abdulnasser Lafta
Department of Gastroenterology and Hepatology
Level 9, Ned Hanlon Building
Royal Brisbane & Women’s Hospital
Herston Qld 4029

Country

Australia

Phone

+61 477063803

Fax

[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.	Type	Citation	Link	Email	Other Details	Attachment
1102	Ethical approval					376767-(Uploaded-18-01-2019-06-55-27)-Study-related document.pdf

Results publications and other study-related documents

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