Randomised, controlled trial evaluating the effectiveness of Probiotic and prawn oral Immunotherapy at inducing desensitisation or tolerance in participants with Prawn Allergy compared with placebo (Probiotic and prawn Immunotherapy for treatment of Prawn Allergy: PIPA study)
A phase 2b, dual-centre, randomised, placebo controlled trial evaluating the effectiveness of Probiotic and prawn oral Immunotherapy at inducing desensitisation or tolerance in participants with Prawn Allergy compared with placebo (Probiotic and prawn Immunotherapy for treatment of Prawn Allergy: PIPA study)
Mimi Tang
80 participants
Oct 1, 2018
Interventional
Conditions
Summary
The primary purpose of the study is to evaluate the efficacy of probiotic and prawn oral immunotherapy compared to placebo in achieving sustained unresponsiveness. 8 weeks post end of treatment phase the participants will be challenged to test if they have achieved sustained unresponsiveness. The trial will include proven prawn allergic people from 5 to 30 years of age. They will be randomised 1:1 into active and placebo groups. The treatment phase will last for 18 months. The trial will last for 5 years.
Eligibility
Inclusion Criteria1
- Confirmed diagnosis of Tiger prawn allergy as defined by a failed DBPCFC with Tiger prawn and a positive SPT or sIgE to prawn or a P monodon allergen component at screening
Exclusion Criteria13
- 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)
- FEV1 less than 85% at rest and FEV1/FVC less than or equal to 85% at rest or 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 ACE inhibitors
- Inflammatory intestinal conditions, indwelling catheters, gastrostomies, immune-compromised states, post-cardiac and/or gastrointestinal tract surgery, critically-ill and those requiring prolonged hospitalisation or other conditions that may increase the risks of probiotic associated sepsis
- Already taking probiotic supplements within the past 6 months
- 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
- 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 safety and blinding)
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Interventions
Participants will be randomised 1:1 into an active (probiotic and prawn immunotherapy) or placebo arm (placebo). All participants begin the trial on 10 mg of prawn powder or placebo which will increase until final dose of 3000 mg (either prawn powder or placebo). A daily dose of L rhamnosus strain probiotic (or placebo) is also taken. This is mixed in water or milk and is to be given immediately prior to the prawn / placebo dosing. If a participant does not tolerate a dose, they will go home on the dose before they reacted. This will mean that they will have an extended build up period as extra doses will be added to the schedule (ie the remaining doses from day 1) The participants are to continue having the doses daily at home at a time suitable for them / their family. Every fortnight they will visit the hospital to increase their dose under supervision. They will be given as a mixture of capsules and sachets (depending on the dose). The participant will be required to open the capsule or sachet and mix the powder with a suitable mixing medium (soup, rice or a food the participant enjoys). The whole dose is to be eaten immediately. If a participant does not tolerate a dose, they will remain on the last dose tolerated for a further 7-14 days and attempt the build up again. They remain on the maintenance dose for the remainder of the active phase of the trial. The active phase of the trial goes for 18 months. The participants will be required to fill in a diary every day to monitor compliance and reactions. Pharmacy also count the returned capsules / sachets to ensure compliance.
Locations(2)
View Full Details on ANZCTR
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ACTRN12618000235202