FARE - Food Allergy Research & Education Logo

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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 1 Year - 10 Years
Gender All
More Inclusion & Exclusion Criteria

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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06297083
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Murdoch Childrens Research Institute
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Paxton Loke
Principal Investigator Affiliation Murdoch Children's Research Institute
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Australia
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Peanut Allergy
Additional Details

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

Arms & Interventions

Arms

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.

Interventions

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Womans and Childrens Hospital, Adelaide, South Australia, Australia

Status

Not yet recruiting

Address

Womans and Childrens Hospital

Adelaide, South Australia, 5006

Site Contact

Michael Gold

Michael.gold@adelaide.edu.au

+61881617000

Murdoch Childrens Research Institute, Melbourne, Victoria, Australia

Status

Recruiting

Address

Murdoch Childrens Research Institute

Melbourne, Victoria, 3052

Site Contact

Julie Burns

hilo.study@mcri.edu.au

+61399366184

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.