CompletedPhase 2ACTRN12608000594325

Study of the effectiveness of Probiotics and Peanut Oral Immunotherapy (P-POIT) in inducing desensitisation or tolerance in children with peanut allergy


Sponsor

Royal Children's Hospital

Enrollment

90 participants

Start Date

Dec 2, 2008

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 1 YearsMax Age: 10 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests whether combining probiotics with gradual exposure to small amounts of peanut protein can help children overcome peanut allergies. It is for children aged 1 to 10 who weigh at least 10 kg and have a confirmed peanut allergy. Children who have had severe allergic reactions causing loss of consciousness, those with poorly controlled asthma, or those allergic to cow's milk or wheat cannot participate.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 m

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.


Locations(1)

VIC, Australia

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