Trial Review

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With activity expected to increase on the ANZCTR again, there may be extended wait times while we process pending studies, with priority being given to those trials submitted in February. Thank you for your patience.


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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12625000216415
Ethics application status
Approved
Date submitted
27/11/2024
Date registered
26/03/2025
Date last updated
26/03/2025
Date data sharing statement initially provided
26/03/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Oral Food Challenges For Food Protein-Induced Enterocolitis Syndrome – A Ten Year Multicentre Audit
Scientific title
Oral Food Challenges For Food Protein-Induced Enterocolitis Syndrome – A Ten Year Multicentre Audit
Secondary ID [1] 313471 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Food Protein Induced Enterocolitis Syndrome 335877 0
Food Allergy 335878 0
Condition category
Condition code
Inflammatory and Immune System 332464 332464 0 0
Allergies
Oral and Gastrointestinal 332604 332604 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Children from birth to 18 years of age inclusive, who undergo food challenge between 2010-2020 to exclude Food protein enterocolitis syndrome were included in the audit.

We reviewed their clinical history from medical notes including past reaction symptoms and trigger foods. We then collected challenge information including food, demographics and outcomes.

We summarised this data to reflect on changes in practice and inform future directions.
Intervention code [1] 330042 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340001 0
Tolerated or not tolerated oral food challenges for food protein enterocolitis syndrome
Timepoint [1] 340001 0
Data for any food challenge completed within the years 2010-2020
Secondary outcome [1] 442267 0
Challenge food used
Timepoint [1] 442267 0
Data for any food challenge completed within the years 2010-2020
Secondary outcome [2] 443379 0
Age at chellenge
Timepoint [2] 443379 0
Data for any food challenge completed within the years 2010-2020
Secondary outcome [3] 445223 0
Symptoms of reaction
Timepoint [3] 445223 0
Data for any food challenge completed within the years 2010-2020
Secondary outcome [4] 445224 0
Treatment of reaction
Timepoint [4] 445224 0
Data for any food challenge completed within the years 2010-2020

Eligibility
Key inclusion criteria
All patients 0-18yo who underwent oral food challenge for food protein enterocolitis syndrome between 2010-2020 at Women's and Children's Health Network and Flinders Medical Centre in Adelaide Australia.
Minimum age
0 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil

Study design
Purpose
Natural history
Duration
Selection
Convenience sample
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/01/2020
Date of last participant enrolment
Anticipated
Actual
1/01/2020
Date of last data collection
Anticipated
Actual
1/01/2021
Sample size
Target
100
Accrual to date
Final
313
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 317907 0
Self funded/Unfunded
Name [1] 317907 0
Country [1] 317907 0
Primary sponsor type
Government body
Name
Women's and Children's Health Network
Address
Country
Australia
Secondary sponsor category [1] 320253 0
None
Name [1] 320253 0
Address [1] 320253 0
Country [1] 320253 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316597 0
Women's and Children's Health Network Human Research Ethics Committee
Ethics committee address [1] 316597 0
Ethics committee country [1] 316597 0
Australia
Date submitted for ethics approval [1] 316597 0
29/07/2019
Approval date [1] 316597 0
18/09/2019
Ethics approval number [1] 316597 0
1116A/09/2022

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

Contacts
Principal investigator
Name 138362 0
Dr Melissa Norman
Address 138362 0
Women's and Children's Hospital, 72 King William Road, North Adelaide, SA, 5006
Country 138362 0
Australia
Phone 138362 0
+610881618638
Fax 138362 0
Email 138362 0
[email protected]
Contact person for public queries
Name 138363 0
Melissa Norman
Address 138363 0
Women's and Children's Hospital, 72 King William Road, North Adelaide, SA, 5006
Country 138363 0
Australia
Phone 138363 0
+610881618638
Fax 138363 0
Email 138363 0
[email protected]
Contact person for scientific queries
Name 138364 0
Melissa Norman
Address 138364 0
Women's and Children's Hospital, 72 King William Road, North Adelaide, SA, 5006
Country 138364 0
Australia
Phone 138364 0
+610881618638
Fax 138364 0
Email 138364 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Medical professionals or researchers employed at a recognised medical facility

Conditions for requesting access:
• -

What individual participant data might be shared?
• Challenge outcomes, age, reaction history, gender

What types of analyses could be done with individual participant data?
• Meta-analysis

When can requests for individual participant data be made (start and end dates)?
From:
from 2025 for a period of 10 years

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• On request to investigator via email
[email protected]

Are there extra considerations when requesting access to individual participant data?
No


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.