Low Dose Multi-Nut Oral Immunotherapy in Pre-schoolers With a Multi-Nut Allergy

Launched by MURDOCH CHILDRENS RESEARCH INSTITUTE · Sep 16, 2021

Keywords

ClinConnect Summary

The LMNOP trial is studying a new treatment approach for young children with allergies to multiple nuts, such as peanuts, almonds, cashews, hazelnuts, and walnuts. This study aims to see if a low-dose oral immunotherapy (OIT) can help children build tolerance to the nuts they are allergic to, compared to the standard advice of strictly avoiding these nuts. Children aged 18 to 36 months who have a confirmed allergy to at least two types of nuts may be eligible to participate. The trial will involve giving some children the OIT for 18 months while others continue to avoid the nuts.

Participants in the trial can expect to either receive the treatment or follow the standard care of nut avoidance. The researchers will then compare how many children in each group can safely eat the nuts after the trial. It’s important to note that this study is looking for children who have had specific allergic reactions to nuts in the past and do not have severe health issues that could complicate their participation. Overall, this trial hopes to find out if this new treatment can help children overcome their nut allergies more effectively than just avoiding them.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Is between the ages of 18 and 36 months at the time of Screening visit 1
• • Has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant's behalf
• * IgE-mediated allergy to 2 of peanut, almond, cashew, hazelnut or walnut, confirmed by:
• Nut 1 pre-screening:
• For at least one of almond, cashew, hazelnut or walnut (Nut 1)\*:
• • 1. History of ingestion with IgE-mediated reaction (birth to present) AND
• • 2. History of SPT ≥3mm OR History of sIgE ≥0.35 number of kilounits per liter (KuL) AND
• Nut 2 pre-screening:
• For a second nut out of peanut, almond, cashew, hazelnut or walnut (Nut 2):
• • History of SPT ≥3mm OR History sIgE ≥0.35 KuL
• • In clinic screening: Participants meeting pre-screening criteria for Nuts 1 and 2 above will be invited for in-clinic screening
• • 1. SPT: wheal size ≥3mm at Visit 1 for 2 of peanut, almond, cashew, hazelnut or walnut AND
• • 2. OFC: react to ≤3000 mg protein top dose (4449 mg cumulative) in open, single nut OFC for 2 of peanut, almond, cashew, hazelnut or walnut
• OFC not needed if:
• • History of failed OFC within past 3 months (confirmed by investigator review of discharge summary) OR History of anaphylaxis after ingestion within past 3 months based on investigator judgement +/- review of ER/Ambulance/medical notes
• • \*Peanut is not included as Nut 1 to reduce the incidence of screening children with a peanut allergy only - children with peanut allergy may have been advised to avoid all other nuts. We require children to have eaten and reacted to at least one tree nut, and then the 2nd nut, which children may or may not have eaten, can be peanut or a tree nut.
• Exclusion Criteria:
• • History of severe anaphylaxis (as defined by persistent hypotension, collapse, loss of consciousness, persistent hypoxia or ever needing more than 2 doses of intramuscular adrenaline or an intravenous adrenaline infusion for management of an allergic reaction)
• • Severe anaphylaxis at study screening OFC (defined as persistent hypotension, collapse, loss of consciousness, persistent hypoxia, or requiring more than 2 doses of intramuscular adrenaline or an intravenous adrenaline infusion for management of an allergic reaction)
• • Fails either screening OFC on dose 1 (0.5 mg).
• • Underlying medical conditions that increase the risks associated with anaphylaxis (e.g., cardiac disease or poorly controlled asthma (defined below))
• • Confirmed eosinophilic esophagitis (EoE) or history indicating EoE
• • Current use of beta-blockers or angiotensin-converting enzyme (ACE) inhibitors
• • Receiving systemic immunomodulatory treatment
• • Not commenced or unable to eat solid food
• • Weight \<7.5kgs (recommended minimum weight for EpiPen Jr (adrenaline autoinjector))
• • Has a sibling in the study
• • Defining uncontrolled asthma (Global Initiative for Asthma. Asthma management and prevention for adults and children older than 5 years)
• In the past 4 weeks, has the patient had:
• • Daytime symptoms more than twice/week? Any night waking due to asthma? Short Acting Beta Agonist (SABA) reliever needed more than twice/week? Any activity limitation due to asthma? Uncontrolled - answered yes to 3-4 of these