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

NCT06297083 | Withdrawn Phase 2

• 1 other identifier: 100992 HILO
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Peanut Allergy

Outcome Measures

Primary Outcomes (1)

• Difference between the treatment arms in the proportion of participants who achieve remission of peanut allergy at 8 weeks post treatment.

  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

  22 months

Secondary Outcomes (11)

• 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 the treatment arms in the exposure-adjusted event rate of adverse events (AE)

  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 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

Study Arms (3)

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

EXPERIMENTAL

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

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

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

EXPERIMENTAL

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

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

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

ACTIVE COMPARATOR

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

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

Interventions

Peanut Oral Powder [PEANUT POWDER] DRUG

Peanut oral immunotherapy at varying doses and build-up regimes given daily for 18 months

Also known as: Peanut oral immunotherapy

High-dose peanut OIT combined with probiotic (HD PPOIT); High-dose peanut OIT combined with probiotic placebo (HD OIT); Low-dose peanut OIT combined with probiotic placebo (LD OIT)

Probiotic (LGG®, Lactobacillus Rhamnosus) or placebo probiotic (maltodextrin) DIETARY_SUPPLEMENT

Probiotic or placebo-probiotic given daily for 18 months

High-dose peanut OIT combined with probiotic (HD PPOIT); High-dose peanut OIT combined with probiotic placebo (HD OIT); Low-dose peanut OIT combined with probiotic placebo (LD OIT)

Eligibility Criteria

• Age: 1 Year - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Murdoch Childrens Research Institute: lead

Related Publications (1)

• Loke P, Orsini F, Lozinsky AC, Gold M, O'Sullivan MD, Quinn P, Lloyd M, Ashley SE, Pitkin S, Axelrad C, Metcalfe JR, Su EL, Tey D, Robinson MN, Allen KJ, Prescott SL, Galvin AD, Tang MLK; PPOIT-003 study group. Probiotic peanut oral immunotherapy versus oral immunotherapy and placebo in children with peanut allergy in Australia (PPOIT-003): a multicentre, randomised, phase 2b trial. Lancet Child Adolesc Health. 2022 Mar;6(3):171-184. doi: 10.1016/S2352-4642(22)00006-2. Epub 2022 Feb 4.

  PMID: 35123664 BACKGROUND

MeSH Terms

Conditions

Peanut Hypersensitivity

Interventions

Probiotics; maltodextrin

Condition Hierarchy (Ancestors)

Nut and Peanut Hypersensitivity; Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Paxton Loke

  Murdoch Childrens Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Participants, outcome assessors, other research staff, treating clinicians, investigators and trial statistician will be blinded to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a three-arm, multi-center, head-to-head randomized study

Study Record Dates

• First Submitted: February 29, 2024
• First Posted: March 6, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: September 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 24 months following article publication
• Access Criteria: These will be made available long-term for use by future researchers from a recognised research institution whose proposed use of the data has been ethically reviewed and approved by an independent committee and who accept MCRI's conditions for access (including any conditions relating to MCRI's intellectual property)