None listed
Conditions
Brief 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.
Interventions
Probiotic and Egg or Milk Oral Immunotherapy: PrEMO study
Egg or milk allergic participants
Participants will commence the study on the RUSH day (rapid updosing schedule day) where increasing doses of egg white powder or milk powder are given (commencing at 0.4 mg and 0.51 mg respectively) along with a single dose of L. rhamnosus strain probiotic. Each participant will be put on a dose for a period of 2 weeks. If the participant reacts to a dose, they will go home on the previous dose. For examp
Probiotic and Egg or Milk Oral Immunotherapy: PrEMO study Egg or milk allergic participants Participants will commence the study on the RUSH day (rapid updosing schedule day) where increasing doses of egg white powder or milk powder are given (commencing at 0.4 mg and 0.51 mg respectively) along with a single dose of L. rhamnosus strain probiotic. Each participant will be put on a dose for a period of 2 weeks. If the participant reacts to a dose, they will go home on the previous dose. For example, if they react to dose 4, they will go home on dose 3, commencing the following day for a period of two weeks. The balance of the RUSH doses will be incorporated into their build up schedule. All participants (regardless of what dose they went home on RUSH day) will continue to come back every two weeks for up-dosing in hospital until the maintenance dose is reached (2000 mg and 3400 mg respectively). Once the maintenance dose is reached, they will come in every three months for a review of treatment until a total of 18 months is complete. The probiotic will be taken as a single daily dose for the duration of the 18 months. Once the 18 months of treatment has been completed, participants will stop taking the study product for 8 weeks, after which they will undergo double-blind placebo-controlled food challenges (DBPCFC) to either egg or milk. First dose of the challenge will be 30mg for egg and 3.4mg for milk, with top doses being 2400mg for egg and 3400mg for milk. Egg white or milk powder will be used to challenge on the active day and a rice flour placebo will be used on the placebo day. This is to determine whether participants remain as "allergic" or has achieved "sustained unresponsiveness". There will be a safety follow up phone call 12 months after treatment completion.
Sponsors
Murdoch Children's Research Institute
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
5 Years to 17 Years
Healthy volunteers
No
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)
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
Outcome results
None listed