Analysing HIgh Dose Probiotic Peanut Oral Immunotherapy (PPOIT) and High Dose Peanut Oral Immunotherapy (OIT) Versus LOw Dose Peanut OIT for Peanut Allergy
Trial Snapshot
- Phase
- Phase 2
- Status
- Withdrawn
- Primary Endpoint
- Difference between the treatment arms in the proportion of participants who achieve remission of peanut allergy at 8 weeks post treatment.
Study Overview
Brief Summary
This study will compare the effectiveness of three different treatments to treat peanut allergy
Detailed Description
This is a three-arm, multi-centre, head-to-head randomised trial, comparing two treatments against a low dose oral immunotherapy approach for peanut allergy.
One hundred and thirty children aged 1 year to 10 years with current peanut allergy confirmed by failed double-blind placebo-controlled food challenge (DBPCFC) at study screening will be recruited for this study. Participants will be recruited from The Royal Children's Hospital Melbourne, Women's and Children's Hospital (Adelaide) and from the general community.
Participants will be randomized to:
- High-dose rapid escalation peanut OIT combined with probiotic (HD PPOIT)
- High-dose rapid escalation peanut OIT combined with probiotic placebo (HD OIT)
- Low-dose slow escalation peanut OIT combined with probiotic placebo (LD OIT)
The length of the treatment period for each participant is 18 months and the post-treatment follow up period is 12 months
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Masking Description
Participants, outcome assessors, other research staff, treating clinicians, investigators and trial statistician will be blinded to treatment allocation.
Eligibility Criteria
- Ages
- 1 Year to 10 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Aged 1-10 years.
- •>7kg (the weight considered safe for the administration of an adrenaline injector);
- •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 (3) 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)
- •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 angiotensin converting enzyme (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
- •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 blinding, safety and equity of access) or in any other clinical trial from the same study group.
Arms & Interventions
High-dose peanut OIT combined with probiotic (HD PPOIT)
High-dose rapid escalation peanut OIT combined with probiotic (HD PPOIT) taken daily for 18 months.
Intervention: Peanut Oral Powder [PEANUT POWDER] (Drug)
High-dose peanut OIT combined with probiotic (HD PPOIT)
High-dose rapid escalation peanut OIT combined with probiotic (HD PPOIT) taken daily for 18 months.
Intervention: Probiotic (LGG®, Lactobacillus Rhamnosus) or placebo probiotic (maltodextrin) (Dietary Supplement)
High-dose peanut OIT combined with probiotic placebo (HD OIT)
High-dose rapid escalation peanut OIT combined with probiotic placebo (HD OIT) taken daily for 18 months
Intervention: Peanut Oral Powder [PEANUT POWDER] (Drug)
High-dose peanut OIT combined with probiotic placebo (HD OIT)
High-dose rapid escalation peanut OIT combined with probiotic placebo (HD OIT) taken daily for 18 months
Intervention: Probiotic (LGG®, Lactobacillus Rhamnosus) or placebo probiotic (maltodextrin) (Dietary Supplement)
Low-dose peanut OIT combined with probiotic placebo (LD OIT)
Low-dose slow escalation peanut OIT combined with probiotic placebo (LD OIT) taken daily for 18 months.
Intervention: Peanut Oral Powder [PEANUT POWDER] (Drug)
Low-dose peanut OIT combined with probiotic placebo (LD OIT)
Low-dose slow escalation peanut OIT combined with probiotic placebo (LD OIT) taken daily for 18 months.
Intervention: Probiotic (LGG®, Lactobacillus Rhamnosus) or placebo probiotic (maltodextrin) (Dietary Supplement)
Outcomes
Primary Outcomes
Difference between the treatment arms in the proportion of participants who achieve remission of peanut allergy at 8 weeks post treatment.
Time Frame: 22 months
Remission will be assessed 8 weeks after the end of treatment timepoint and is defined as passing (completing without reaction) the double-blind placebo controlled food challenge (DBPCFC) at the end of treatment and at 8 weeks post treatment
Secondary Outcomes
- Difference between the treatment arms in the exposure-adjusted event rate of adverse events (AE)(20 months)
- Difference between treatment arms in changes in the peanut skin prick test (SPT) wheal size.(Baseline, 76 weeks, 84 weeks,128 weeks)
- Difference between treatment arms in change from baseline peanut specific immunoglobulin E (sIgE) levels(Baseline, 76 weeks, 84 weeks,128 weeks)
- Difference between the treatment arms in the proportion of participants who achieve full desensitisation of peanut allergy at end of treatment(20 months)
- Difference between treatment arms in changes in Quality of Life Scores using the Food Allergy Quality of Life Questionnaires (FAQLQ).(Baseline, 22weeks, 76 weeks, 84 weeks, 128 weeks)
- Difference between treatment arms in adherence to treatment regime as measured by daily treatment doses taken by the participant(20 months)
- Difference between treatment arms in participant experience as assessed from qualitative interviews(20 months)
- Difference between clinical outcome groups in cost using the Consolidated Health Economic Evaluation Reporting Standards (CHEERS)(Baseline through to 32 months)
- Difference between clinical outcome groups in quality adjusted life year (QALY) will be estimated at 32 months using the Food Allergy Quality of Life Form (FAQLQ) mapped to the generic health utility instrument Assessment of Quality of Life-6D (AQoL-6D)(32 months)
- Difference between clinical outcome groups in peanut ingestion from end of treatment to 12 months post treatment(20 months to 32 months)
- Difference between clinical outcome groups in reactions to peanut from end of treatment to 12 months post treatment(20 months to 32 months)