None listed
Conditions
Brief summary
Peanut allergy is a common allergy in Australia. As many as one in 200 children and 3 percent of infants have a peanut allergy. Reactions may occur after eating very small amounts of peanut. Reactions to peanut may be severe and life threatening. Peanut allergy is the commonest cause of severe life-threatening reactions (anaphylaxis) and death due to food allergy. Peanut allergy usually persists throughout life. Peanut oral immunotherapy (OIT) is a treatment where a person who is allergic to peanut is asked to eat peanut, starting at very low doses then increasing to a higher maintenance dose that they will then continue to take daily dose for a specified amount of time. This research is looking to recruit up to 40 participants in an open label trial where ALL participants will receive the active peanut OIT treatment over a 12month treatment period. In our previous peanut oral immunotherapy trials, children were given peanut OIT treatment over a course of 18 months. At the completion of the study we found that 80% of the participants who received the active peanut OIT were able to tolerate peanut in their diets. This new study will aim to investigate whether a 12-month treatment plan can achieve the same levels of remission in children. In this study, we want to find out if peanut oral immunotherapy treatment over the course of 12 months is: • Effective in producing tolerance in children with peanut allergies • Able to produce a long-term tolerance of up to 8 weeks
Interventions
FEAST trial
Peanut allergic participants aged 1 year old and up to and including 10 years old.
Participants will commence the study on the RUSH day (rapid updosing schedule day) where increasing doses of peanut flour (commencing at 0.1mg up to 12mg) are mixed in a food the child enjoys (eg yoghurt) and given. If the participant tolerates all of the doses they will commence dose 9 the following day for a period of two weeks. If the participant reacts to a dose, they will go home on the previous d
FEAST trial Peanut allergic participants aged 1 year old and up to and including 10 years old. Participants will commence the study on the RUSH day (rapid updosing schedule day) where increasing doses of peanut flour (commencing at 0.1mg up to 12mg) are mixed in a food the child enjoys (eg yoghurt) and given. If the participant tolerates all of the doses they will commence dose 9 the following day for a period of two 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. For all study treatment we have a stopping criteria that dictates when to stop study treatment. symptoms may include vomiting, severe abdominal pain, widespread hives etc. 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). Once the maintenance dose is reached, they will come in every 12 weeks for a review of treatment until a total of 12 months is complete. If the participant is having trouble reaching maintenance dose within the prescribed timeframe their progress will be discussed and decided by the PI. In this case treatment will not be extended past 12 months. Once the 12 months of treatment has been completed, the participants will have a double-blind placebo-controlled food challenge (DBPCFC) to check to see if they have been desensitised. Peanut flour will be used to challenge on the active day and a maltodextrin placebo will be used on the placebo day. First dose of the challenge will be 80mg with the top dose being 2500mg. If they pass this challenge, they will return for another DBPCFC 8 weeks later to see if they have achieved sustained unresponsiveness. If they fail the first challenge, they will come back 8 weeks later for an appointment but no DBPCFC will be performed. For those not completing the food challenge, a blood sample will be taken, a skin prick test performed and questionnaires administered. There will be a follow up visit 12 months after the completion of study treatment
Sponsors
Murdoch Children's Research Institute
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
1 Years to 10 Years
Healthy volunteers
No
Inclusion criteria
Aged 1 to10 years. Greater than 7kg (the weight considered safe for the administration of an Epipen/EpiPen Jr); Confirmed diagnosis of peanut allergy as defined by a failed DBPCFC with peanut and a positive SPT or sIgE to peanut at screening; Has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant’s behalf.
Exclusion criteria
History of severe anaphylaxis (as defined by persistent hypotension, collapse, loss of consciousness, persistent hypoxia or ever needing more than three doses of intramuscular adrenaline or an intravenous adrenaline 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 or an intravenous adrenaline infusion for management of an allergic reaction) FEV1 greater than 85 percent at rest and FEV1/FVC equal to 85 percent 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 Use of beta-blockers, and ACE inhibitors 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 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)
Outcome results
None listed