Australian Clinical Trials

Broad Health Condition Inflammatory and Immune System

Specific Health ConditionAllergies

Trial FocusTreatment

Recruitment Details

Recruitment status
Active, not recruiting

Recruitment State
VIC

Hospital
The Royal Childrens Hospital - Parkville

Postcode
3052 - Parkville

Trial location outside Australia
Singapore

Anticipated date of first participant enrolment1/10/2019

Anticipated date of last participant enrolment30/09/2020

Phase of TrialPhase 2

Has the study received ethics approval?Approved

Trial summary

The primary purpose of the study is to evaluate the efficacy of probiotic and egg oral immunotherapy compared to placebo in achieving sustained unresponsiveness in participants with egg allergy 8 weeks after end-of-treatment.
The trial will include proven egg allergic people from 5 to 30 years of age. They will be randomised 1:1 into active and placebo groups. This study is expected to run for 4 years from the start of participant screening to the last participant finishing the study. The length of the treatment period for each participant is 18 months and the follow up period is 3 months.

The discovery of a safe and tolerable treatment for food allergy will have great public health benefit.

Key inclusion criteria

Subjects are eligible for the study if they meet all of the following criteria:
- Aged between 5 and 30 years of age
- Confirmed diagnosis of egg allergy as defined by a failed DBPCFC and a positive SPT or sIgE to egg at screening

Minimum age5 Years

Maximum age30 Years

GenderBoth males and females

Can Healthy volunteers participate? No

Key exclusion criteria

Subjects are not eligible for the study if they meet any of the following criteria:
•	Subjects who are on an egg ladder diet (except baked egg) 
•	History of severe anaphylaxis (as defined by persistent hypotension, collapse, loss of consciousness, persistent hypoxia or ever needing more than three (3) doses of intramuscular adrenaline (epinephrine) or an intravenous adrenaline (epinephrine) infusion for management of an allergic reaction)
•	Severe anaphylaxis during the study entry DBPCFC (defined as persistent hypotension, collapse, loss of consciousness, persistent hypoxia, or requiring more than 3 doses of intramuscular adrenaline (epinephrine) or an intravenous adrenaline (epinephrine) infusion for management of an allergic reaction)
•	FEV1 less than 85% predicted at rest and FEV1/FVC is less than or equal to 85% predicted at rest (for those participants able to perform spirometry testing) or ongoing chronic persistent asthma (as per Australian Asthma Foundation guidelines)
•	Underlying medical conditions (e.g. cardiac disease) that increase the risks associated with anaphylaxis
•	Use of beta-blockers, and ACE inhibitors
•	Inflammatory intestinal conditions, indwelling catheters, gastrostomies, immune-compromised states, post-cardiac and/or gastrointestinal tract surgery, critically-ill and those requiring prolonged hospitalisation or other conditions that may increase the risks of probiotic associated sepsis
•	Already taking probiotic supplements  or food containing probiotics in the last month. 
•	Reacting to the placebo component during the study entry DBPCFC
•	Have received other food immunotherapy treatment in the preceding 12 months
•	Currently taking immunomodulatory therapy (including allergen immunotherapy)
•	Past or current major illness that in the opinion of the Site Investigator may affect the subject’s ability to participate in the study e.g. increased risk to the participant
•	History of suspected or biopsy-confirmed eosinophilic oesophagitis (EoE)
•	Subjects who in the opinion of the Site Investigator are unable to follow the protocol 
•	Another family member already enrolled in the trial (to maintain safety and blinding)
•	Non-English speaking participants and families
•	Participants 18 years or over (RCH site only)

NOTE: participants with other food allergies are NOT excluded from participating in this trial.