None listed
Conditions
Brief summary
A two arm randomised-controlled trial to test a novel therapy (Peanut Oral Immunotherapy with a Probiotic adjunct) against placebo. The findings of this study will provide much needed evidence on whether OIT combined with a probiotic adjunct can induce tolerance in children with peanut allergy.
Interventions
Lactobacillus rhamnosus GG (LGG) and Peanut Oral Immunotherapy
LGG - 1 scoop delivering 2x10E10 Colony-forming units (cfu) of LGG taken once daily for 18 months dissolved into water, soy or cow’s milk, at a temperature NOT exceeding 45 °C
Peanut Oral Immunotherapy (OIT) - In the modified rush phase, subjects will receive increasing doses of peanut oral immunotherapy, starting at 0.1mg peanut protein with doubling of the dosage every 30 minutes to reach a final dose of 12mg of peanut protein (i
Lactobacillus rhamnosus GG (LGG) and Peanut Oral Immunotherapy LGG - 1 scoop delivering 2x10E10 Colony-forming units (cfu) of LGG taken once daily for 18 months dissolved into water, soy or cow’s milk, at a temperature NOT exceeding 45 °C Peanut Oral Immunotherapy (OIT) - In the modified rush phase, subjects will receive increasing doses of peanut oral immunotherapy, starting at 0.1mg peanut protein with doubling of the dosage every 30 minutes to reach a final dose of 12mg of peanut protein (in total 8 doses delivered in 1 day, with a cumulative dose of 24mg peanut protein). In the buildup phase, the daily dose of peanut OIT will start at 24mg peanut protein and will be increased every 2 weeks until a maintenance dose of 2g is reached (expected to take 8 months). Dosage increments are as follows :- 24mg, 25mg, 50mg, 75mg, 100mg, 125mg, 150mg, 200mg, 260mg, 330mg, 425mg, 550mg, 715mg, 925mg, 1.2g, 1.55g and 2g. If mild allergic symptoms develop (urticaria, angioedema, vomiting, abdominal pain), the dose is repeated before increasing. If moderate/severe allergic symptoms occur (stridor, wheeze) the dose will be reduced by 25% before proceeding. If severe anaphylaxis develops (reduced BP, loss of consciousness) OIT will be discontinued. The dose is maintained at 2g for about 10 months, but will be shorter for subjects who take longer to reach maintenance dose. Peanut oral immunotherapy will administered orally in all phases with the peanut protein sprinkled and mixed into yoghurt. The overall duration of the intervention is 18 months.
Sponsors
Royal Children's Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
1 Years to 10 Years
Healthy volunteers
No
Inclusion criteria
Children are eligible for the study if they: 1) Are aged between 1 year and 10 years of age 2) Are above 10kg 3) There is a confirmed diagnosis of peanut allergy as defined by: -a positive food challenge to peanut in the past 2 years AND a positive skin prick test (SPT) or Capsulated Hydrophobic Carrier Polymer- Radioallergosorbent Test (CAP-RAST) to peanut OR -a positive food challenge or history of reaction to peanut ever AND a positive SPT greater than or equal to 8mm or a CAP-RAST greater than or equal to 15KU/l to peanut
Exclusion criteria
Children will not be eligible for the study if they have a history of: 1) severe anaphylaxis (as defined by hypotension , collapse, loss of consciousness or hypoxia) 2) Forced Expiratory Volume in 1 Second (FEV1) of <85% at rest or ongoing chronic persistent asthma (as per Australian Asthma Foundation guidelines) 3) Underlying medical conditions (eg cardiac disease) that increase the risks associated with anaphylaxis 4) Known wheat allergy (the placebo may contain traces of wheat) 5) Use of beta-blockers 6) Inflammatory intestinal conditions, indwelling catheters, gastrostomies or other conditions that may increase the risks of probiotic associated sepsis 7) Cow’s milk allergy, as there may be traces of cow’s milk in the probiotic preparation 8) Already taking probiotics
Outcome results
None listed