An interventional study of Nut challenge and Nut challenge: Placebo in Nut Allergy, sponsored by Helsinki University Central Hospital. Completed at 2 sites in Finland. Open to participants aged 3 Years to 18 Years. Per ClinicalTrials.gov, last updated 2016-09-13.
Sponsored by Helsinki University Central Hospital · Not applicable, Interventional, and Treatment
Nut sensitization in skin prick tests is common in areas, including Finland, where birch pollen is abundant. However, sensitization to nuts in skin prick test does not predict the possibility of allergic symptoms when nuts are ingested. In this study the investigators launch and perform double-blind placebo-controlled nut challenges and oral desensitization/ protocol to those with serious symptoms in the challenge. The efficacy and safety of the new oral desensitization program is the primary outcome. The effect of oral desensitization on bronchial hyperreactivity, eosinophilic airway inflammation, and quality of life are secondary outcomes.
The investigators aim to improve nut allergy diagnosis by launching a new double-blind placebo-controlled nut (peanut, hazel nut, cashew) challenge protocol. The investigators also launch a specific oral tolerance induction (SOTI) protocol to nuts in serious nut allergy. This study takes place in the Helsinki University Skin and Allergy Hospital between May 2011 and December 2015. Inclusion criteria: age 6 to 18 years and suspected nut allergy (unclear anaphylaxis possibly caused by nuts, skin prick test to nuts ≥ 10 mm or specific-IgE ≥ 20 kU/L and have never eaten nuts, or avoids nuts and does not dare try nuts at home). Patients having uncontrolled asthma or other lung disease, having cardiovascular disease or other systemic disease, using beta-blockers, and having poor compliance, are excluded. Methods:The investigators perform skin prick tests to peanut, tree nuts and seeds, take a blood sample before the double-blind placebo-controlled food challenges (DBPCFC), and measure total IgE and specific-IgE to birch, peanut, hazel nut, allergen components Ara h 1, 2, 3, and 8, and Cor a 1 and 8. Then the serum samples are kept frozen for further component and immunologic analyses. The investigators put iv before the challenge. In DBPCFC the patients receive 5 mg, 50 mg, 200mg, and 1000mg nut protein mixt with placebo, or placebo every 30 minutes. The severity of the allergic reaction is estimated using a modified severity scale. The probability of severe/moderate reaction at low (\<0.7 kU/L) and at increased (>0.7 kU/L) Ara h 2 and 8 concentrations is the primary end-point in the DBPCFC. The investigators also correlate the concentrations of Ara h 2 with the severity score. Patients with moderate or severe reaction in the challenge will be offered desensitization therapy "SOTI" using(pea)nut flour mixed with milk-free margarine. The first dose of 0.1 mg nut protein is given at hospital part of the up-dosing is made at home every 2 weeks. The patient takes an antihistamine 1 hour before each daily dose. An epinephrine autoinjector and prednisolone tablets are also prescribed for emergency use. The desensitization protocol takes 28 weeks and is personalized when needed. Exercise is avoided 1 hour following each dose. Before and after the SOTI the investigators measure food related quality of life using standardized questionnaires, and perform metacholine challenge and measure exhaled nitric oxid. After the SOTI the investigators take blood samples and perform DBPCFC again.
33 studies on the registry are indexed under Nut Hypersensitivity; 9 are open to participants now.
This study's enrollment of 102 is above the median of 47 across 20 interventional studies indexed under Nut Hypersensitivity.
Browse Nut Hypersensitivity studies →Helsinki University Central Hospital is the lead sponsor of 311 studies on the registry; 61 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Double-blind placebo controlled oral challenge 5-50-200-1000 mg peanut or hazelnut protein, or placebo administered with 30 min intervals and 2 hour-follow-up after the last dose.
Dietary Supplement: Nut challenge
See intervention
Dietary Supplement: Nut challenge: Placebo
Patients who have moderate to severe immediate allergic reaction at peanut challenge and who enter the oral desensitization program receive peanut protein daily, from 0,1 mg to 800 mg peanut protein, maintenance dose 800 mg.
Dietary Supplement: Nut oral desensitization
Nut powder made from non-roasted nuts and roasted banana mixed with oats yoghurt or chocolate pudding
Also known as: Super nuts banan chips, Yosa oat yoghurt, Arla cowpower chololate pudding
Dried banana mixed with oat yoghurt or chocolate pudding
Also known as: Super nuts banan chips, Yosa oat yoghurt, Arla cowpower chololate pudding
Roasted peanut powder mixed with milk- and soy-free margarine
Also known as: Old Virginia Byrd Mill Fat-Light roasted peanut, Keiju-margarine
Efficacy of nut oral desensitization
Change from baseline in the amount of nut (mg) tolerated in a double-blind placebo-controlled oral challenge at 1 month after the 6-month oral desensitization therapy.
Time frame: 7 months
Effect of the treatment on quality of life
Change from baseline in Quality of life questionnaire square before and after the oral desensitization therapy
Time frame: 7 months
Effect of the treatment on bronchial hyperreactivity and airway inflammation
Change from baseline in bronchial hyperreactivity in metacholine challenge and in eosinophilic airway inflammation measured by multiple channel exhaled nitric oxid
Time frame: 1 year
Safety of nut oral desensitization therapy
Number of participants with adverse events as a measure of safety and tolerability
Time frame: 7 months
Effect of the treatment on eosinophilic airway inflammation
Change from baseline in exhaled nitric oxid concentration
Time frame: 1 year
This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Helsinki University Central Hospital →