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

Peanut Allergy Clinical Trial

— HILO  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06297083
• Other study ID #: 100992
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: April 2024
• Est. completion date: December 2027

Study information

• Verified date: April 2024
• Source: Murdoch Childrens Research Institute
• Contact: Julie Burns, Study Coordinator
• Phone: +61399366184
• Email: hilo.study[@]mcri.edu.au
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 130
• Est. completion date: December 2027
• Est. primary completion date: February 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 10 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypersensitivity
• Peanut Allergy
• Peanut Hypersensitivity

Intervention

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

Dietary Supplement:
• Probiotic (LGG®, Lactobacillus Rhamnosus) or placebo probiotic (maltodextrin)
Probiotic or placebo-probiotic given daily for 18 months

Locations

Country	Name	City	State
Australia	Womans and Childrens Hospital	Adelaide	South Australia
Australia	Murdoch Childrens Research Institute	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Murdoch Childrens Research Institute

Country where clinical trial is conducted

Australia, 

References & 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. Erratum In: Lancet Child Adolesc Health. 2022 May;6(5):e19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	20 months
Secondary	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)	20 months
Secondary	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	Baseline, 22weeks, 76 weeks, 84 weeks, 128 weeks
Secondary	Difference between treatment arms in changes in the peanut skin prick test (SPT) wheal size.	Skin prick test to whole peanut extract	Baseline, 76 weeks, 84 weeks,128 weeks
Secondary	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)	Baseline, 76 weeks, 84 weeks,128 weeks
Secondary	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	20 months
Secondary	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	20 months
Secondary	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	Baseline through to 32 months
Secondary	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
Secondary	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	20 months to 32 months
Secondary	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	20 months to 32 months