Analysing HIgh Dose Probiotic Peanut Oral Immunotherapy (PPOIT) and High Dose Peanut Oral Immunot… (NCT06297083) | Clinical Trial Compass
WithdrawnPhase 2
Analysing HIgh Dose Probiotic Peanut Oral Immunotherapy (PPOIT) and High Dose Peanut Oral Immunotherapy (OIT) Versus LOw Dose Peanut OIT for Peanut Allergy
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.
0Started 2024-05
Plain-language summary
This study will compare the effectiveness of three different treatments to treat peanut allergy
Who can participate
Age range1 Year – 10 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 t…
What they're measuring
1
Difference between the treatment arms in the proportion of participants who achieve remission of peanut allergy at 8 weeks post treatment.