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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06297083




Registration number
NCT06297083
Ethics application status
Date submitted
29/02/2024
Date registered
6/03/2024

Titles & IDs
Public title
Analysing HIgh Dose Probiotic Peanut Oral Immunotherapy (PPOIT) and High Dose Peanut Oral Immunotherapy (OIT) Versus LOw Dose Peanut OIT for Peanut Allergy
Scientific title
Analysing HIgh Dose Probiotic Peanut Oral Immunotherapy (PPOIT) and High Dose Peanut Oral Immunotherapy (OIT) Versus LOw Dose Peanut OIT for Peanut Allergy
Secondary ID [1] 0 0
100992 HILO
Universal Trial Number (UTN)
Trial acronym
HILO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peanut Allergy 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Allergies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Peanut Oral Powder [PEANUT POWDER]
Treatment: Other - Probiotic (LGG®, Lactobacillus Rhamnosus) or placebo probiotic (maltodextrin)

Experimental: 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.

Experimental: 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

Active comparator: 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.


Treatment: Drugs: Peanut Oral Powder [PEANUT POWDER]
Peanut oral immunotherapy at varying doses and build-up regimes given daily for 18 months

Treatment: Other: Probiotic (LGG®, Lactobacillus Rhamnosus) or placebo probiotic (maltodextrin)
Probiotic or placebo-probiotic given daily for 18 months
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Difference between the treatment arms in the proportion of participants who achieve remission of peanut allergy at 8 weeks post treatment.
Timepoint [1] 0 0
22 months
Secondary outcome [1] 0 0
Difference between the treatment arms in the proportion of participants who achieve full desensitisation of peanut allergy at end of treatment
Timepoint [1] 0 0
20 months
Secondary outcome [2] 0 0
Difference between the treatment arms in the exposure-adjusted event rate of adverse events (AE)
Timepoint [2] 0 0
20 months
Secondary outcome [3] 0 0
Difference between treatment arms in changes in Quality of Life Scores using the Food Allergy Quality of Life Questionnaires (FAQLQ).
Timepoint [3] 0 0
Baseline, 22weeks, 76 weeks, 84 weeks, 128 weeks
Secondary outcome [4] 0 0
Difference between treatment arms in changes in the peanut skin prick test (SPT) wheal size.
Timepoint [4] 0 0
Baseline, 76 weeks, 84 weeks,128 weeks
Secondary outcome [5] 0 0
Difference between treatment arms in change from baseline peanut specific immunoglobulin E (sIgE) levels
Timepoint [5] 0 0
Baseline, 76 weeks, 84 weeks,128 weeks
Secondary outcome [6] 0 0
Difference between treatment arms in adherence to treatment regime as measured by daily treatment doses taken by the participant
Timepoint [6] 0 0
20 months
Secondary outcome [7] 0 0
Difference between treatment arms in participant experience as assessed from qualitative interviews
Timepoint [7] 0 0
20 months
Secondary outcome [8] 0 0
Difference between clinical outcome groups in cost using the Consolidated Health Economic Evaluation Reporting Standards (CHEERS)
Timepoint [8] 0 0
Baseline through to 32 months
Secondary outcome [9] 0 0
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)
Timepoint [9] 0 0
32 months
Secondary outcome [10] 0 0
Difference between clinical outcome groups in peanut ingestion from end of treatment to 12 months post treatment
Timepoint [10] 0 0
20 months to 32 months
Secondary outcome [11] 0 0
Difference between clinical outcome groups in reactions to peanut from end of treatment to 12 months post treatment
Timepoint [11] 0 0
20 months to 32 months

Eligibility
Key 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
Minimum age
1 Year
Maximum age
10 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/05/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2027
Actual
Sample size
Target
Accrual to date
Final
0
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Primary sponsor type
Other
Name
Murdoch Childrens Research Institute
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Paxton Loke
Address 0 0
Murdoch Children's Research Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Julie Burns, Study Coordinator
Address 0 0
Country 0 0
Phone 0 0
+61399366184
Fax 0 0
Email 0 0
hilo.study@mcri.edu.au
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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)

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF)
When will data be available (start and end dates)?
Beginning 24 months following article publication
Available to whom?
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)
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.melbournechildrens.com/mctc/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06297083