Australian Clinical Trials

Broad Health Condition Inflammatory and Immune System

Specific Health ConditionAllergies

Trial FocusTreatment

Recruitment Details

Recruitment status
Completed

Recruitment State
VIC

Hospital
The Royal Childrens Hospital - Parkville

Postcode
3052 - Parkville

Anticipated date of first participant enrolment18/03/2019

Anticipated date of last participant enrolment12/08/2019

Phase of TrialNot Applicable

Has the study received ethics approval?Approved

Trial summary

An Open-label Study of Probiotic and Hen’s Egg or Cow’s Milk Oral Immunotherapy. This study is looking at the tolerability of the RUSH (rapid updosing schedule) and build up schedules. 

Key inclusion criteria

•	Aged between 5 and 17 years of age
•	Confirmed diagnosis of egg allergy or cow’s milk allergy as defined by a failed DBPCFC and a positive SPT or sIgE to egg or cow’s milk at screening 
•	Participants who are on an egg or milk elimination diet (baked egg or baked milk ingestion is allowed)

Minimum age5 Years

Maximum age17 Years

GenderBoth males and females

Can Healthy volunteers participate? No

Key exclusion criteria

•	Subjects who are on an egg or milk ladder diet (except baked egg or baked milk) 
•	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 of less than 85% predicted at rest and FEV1/FVC of less than or equal to 85% predicted at rest 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
•	History of eosinophilic oesophagitis (EoE)
•	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 within the past 6 months
•	Reacting to the placebo component during the study entry DBPCFC
•	Currently receiving or 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
•	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