Analysing HIgh Dose Probiotic Peanut Oral Immunotherapy (PPOIT) and High Dose Peanut Oral Immunotherapy (OIT) Versus LOw Dose Peanut OIT for Peanut Allergy (HILO)

Murdoch Childrens Research Institute

Status and phase: Withdrawn; Phase 2

Conditions: Peanut Allergy

Treatments: Drug: Peanut Oral Powder [PEANUT POWDER]; Dietary Supplement: Probiotic (LGG®, Lactobacillus Rhamnosus) or placebo probiotic (maltodextrin)

Study type: Interventional

Funder types: Other

Identifiers

NCT06297083

100992 HILO

Details and patient eligibility

About

This study will compare the effectiveness of three different treatments to treat peanut allergy

Full 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:

1. High-dose rapid escalation peanut OIT combined with probiotic (HD PPOIT)
2. High-dose rapid escalation peanut OIT combined with probiotic placebo (HD OIT)
3. 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

Sex: All

Ages: 1 to 10 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 3 patient groups

High-dose peanut OIT combined with probiotic (HD PPOIT)

Experimental group

Description:

High-dose rapid escalation peanut OIT combined with probiotic (HD PPOIT) taken daily for 18 months.

Treatment:

Dietary Supplement: Probiotic (LGG®, Lactobacillus Rhamnosus) or placebo probiotic (maltodextrin)

Drug: Peanut Oral Powder [PEANUT POWDER]

High-dose peanut OIT combined with probiotic placebo (HD OIT)

Experimental group

Description:

High-dose rapid escalation peanut OIT combined with probiotic placebo (HD OIT) taken daily for 18 months

Treatment:

Dietary Supplement: Probiotic (LGG®, Lactobacillus Rhamnosus) or placebo probiotic (maltodextrin)

Drug: Peanut Oral Powder [PEANUT POWDER]

Low-dose peanut OIT combined with probiotic placebo (LD OIT)

Active Comparator group

Description:

Low-dose slow escalation peanut OIT combined with probiotic placebo (LD OIT) taken daily for 18 months.

Treatment:

Dietary Supplement: Probiotic (LGG®, Lactobacillus Rhamnosus) or placebo probiotic (maltodextrin)

Drug: Peanut Oral Powder [PEANUT POWDER]