This site is now managed by the Commonwealth Department of Health and Aged Care.
Broad Health Condition Inflammatory and Immune System
Specific Health ConditionAllergies
Active, not recruiting
The Royal Childrens Hospital - Parkville
3052 - Parkville
Trial location outside Australia
Anticipated date of first participant enrolment1/10/2019
Anticipated date of last participant enrolment30/09/2020
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
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.
Sponsor Primary Sponsor Type: Other
Primary Sponsor Name: Murdoch Children's Research Institute
Primary Sponsor Address: The Royal Children's Hospital, Flemington Road, Parkville, Victoria 3052
Primary Sponsor Country: Australia
Contact person for information and recruitmentMiss
Murdoch Children's Research Institute 50 Flemington Road Parkville, 3052, Victoria
Email contact email@example.comAustralia