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Peanut AllergyPhase 2HILONCT06297083

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

A Phase 2 study testing Peanut Oral Powder [PEANUT POWDER] in people with Peanut Allergy, run by Murdoch Childrens Research Institute.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This study will compare the effectiveness of three different treatments to treat peanut allergy Read more about this study

Who is it for?
Ages 1 year to 10 yearsHealthy volunteers can take part
Conditions the study is for
Peanut Allergy
What is being tested?
Peanut Oral Powder [PEANUT POWDER]
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
No sites listed yet
Study dates
May 2024to May 2027
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 10 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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.

About this study

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

Read the 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:

  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

Conditions
Peanut Allergy
Being tested
Peanut Oral Powder [PEANUT POWDER], Probiotic (LGG®, Lactobacillus Rhamnosus) or placebo probiotic (maltodextrin)
Medical subject headings
Peanut Hypersensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Peanut Oral Powder [PEANUT POWDER]Drug

    Also called Peanut oral immunotherapy

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

  • Probiotic (LGG®, Lactobacillus Rhamnosus) or placebo probiotic (maltodextrin)Dietary supplement

    Probiotic or placebo-probiotic given daily for 18 months

Study groups in NCT06297083
Study groupRoleWhat they receive
High-dose peanut OIT combined with probiotic (HD PPOIT)ExperimentalHigh-dose rapid escalation peanut OIT combined with probiotic (HD PPOIT) taken daily for 18 months.
Receives: 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)ExperimentalHigh-dose rapid escalation peanut OIT combined with probiotic placebo (HD OIT) taken daily for 18 months
Receives: 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 comparatorLow-dose slow escalation peanut OIT combined with probiotic placebo (LD OIT) taken daily for 18 months.
Receives: Drug: Peanut Oral Powder [PEANUT POWDER]; Dietary Supplement: Probiotic (LGG®, Lactobacillus Rhamnosus) or placebo probiotic (maltodextrin)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 22 months

Secondary outcomes (11)

  1. Difference between the treatment arms in the proportion of participants who achieve full desensitisation of peanut allergy at end of treatment

    Full desensitisation will be defined by participants passing (completing without reaction) the double-blind placebo controlled food challenge (DBPCFC) undertaken at the end of treatment

    Measured: 20 months

  2. Difference between the treatment arms in the exposure-adjusted event rate of adverse events (AE)

    The total number of treatment-related AE the participant reports during the course of treatment adjusted for the time the participant is on treatment (in years)

    Measured: 20 months

  3. Difference between treatment arms in changes in Quality of Life Scores using the Food Allergy Quality of Life Questionnaires (FAQLQ).

    FAQLQ total score, as well as three sub-scores (food anxiety, general emotional impact, and social and dietary limitations) will be calculated as per the instrument scoring manual

    Measured: Baseline, 22weeks, 76 weeks, 84 weeks, 128 weeks

  4. Difference between treatment arms in changes in the peanut skin prick test (SPT) wheal size.

    Skin prick test to whole peanut extract

    Measured: Baseline, 76 weeks, 84 weeks,128 weeks

  5. Difference between treatment arms in change from baseline peanut specific immunoglobulin E (sIgE) levels

    Blood samples will be collected and levels of sIgE against peanut will be measured by ImmunoCAP (Phadia AB, Uppsala, Sweden)

    Measured: Baseline, 76 weeks, 84 weeks,128 weeks

  6. Difference between treatment arms in adherence to treatment regime as measured by daily treatment doses taken by the participant

    Adherence to treatment will be monitored by reviewing the participant diary

    Measured: 20 months

  7. Difference between treatment arms in participant experience as assessed from qualitative interviews

    Interview guide developed and conducted, recorded, transcribed verbatim, and responses explored using framework analysis

    Measured: 20 months

  8. Difference between clinical outcome groups in cost using the Consolidated Health Economic Evaluation Reporting Standards (CHEERS)

    Captured per number of hospitalizations, Emergency room (ER) visits, General Practitioner (GP) visits and medications / number of prescriptions required. Data acquired using participant questionnaires, participant study diaries and supplemented by administrative hospital data linkage

    Measured: Baseline through to 32 months

  9. 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)

    Measured: 32 months

  10. Difference between clinical outcome groups in peanut ingestion from end of treatment to 12 months post treatment

    Peanut ingestion data will be captured from the participant's study diary

    Measured: 20 months to 32 months

  11. Difference between clinical outcome groups in reactions to peanut from end of treatment to 12 months post treatment

    Number of reactions, symptoms experienced, and treatment administered will be captured from the participant's study diary

    Measured: 20 months to 32 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2024
  2. Study startMay 2024 (estimated)
  3. Primary completionMay 2027 (estimated)
  4. Study completionMay 2027 (estimated)

Why it stopped: Delays in manufacturing \& increased costs of materials, manufacturing and logistics identified during trial set up caused the trial budget to exceed the available funds and an inability to complete the study within required grant timelines.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a three-arm, multi-center, head-to-head randomized study
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06297083
Sponsor's protocol ID
100992 HILO
Acronym
HILO
Status last verified
Aug 2024
First submitted
29 Feb 2024
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Beginning 24 months after article publication, the following 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): * Individual participant data that underlie the results reported in this article after de-identification (text, tables, figures and appendices) * Trial protocol, Statistical Analysis Plan, Informed Consent Form (ICF)

Publications

  • 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.

    PubMed 35123664

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Peanut Oral Powder [PEANUT POWDER] in people with Peanut Allergy, run by Murdoch Childrens Research Institute.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06297083, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.

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