Pérez‐Rangel 2017.
Methods | Randomized clinical trial | |
Participants | 33 persistent egg‐allergic children, 5 years to 18 years old, with egg allergy diagnosis based on the presence of IgE‐ mediated symptoms, positive skin prick test (SPT) (≥ 3 mm) and/or specific IgE (sIgE) levels ≥ 0.7 kU/L or higher for whole egg, egg white, ovalbumin (OVA) and/or ovomucoid (OVM), and a positive double‐blind placebo‐controlled food challenge (DBPCFC) to dehydrated egg white at enrolment. | |
Interventions | A consecutive 5‐day build‐up phase was designed, starting at the highest tolerated single dose in the baseline egg DBPCFC. The build‐up phase target dose was 3,600 mg of dehydrated egg white (approximately 2808 mg of egg white protein). A cumulative dose of 5400 mg of dehydrated egg white (approximately 4212 mg protein) was administered on the last day. The maintenance phase consisted of eating 1 undercooked egg (undercooked fried egg, scrambled egg, or omelet) every 48 hours. In addition, the participants could freely take any other egg‐containing foodstuffs. Control group: egg avoidance diet during 5 months |
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Outcomes | The primary study outcome was the efficacy to induce desensitization to egg after 5 months of treatment. Desensitization was defined as the participant's ability to eat 1 undercooked egg with no or mild adverse events. Secondary objectives were:
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Vested interest | Quote: "Authors have nothing to disclose." | |
Notes | The study was part of a research project supported in part by the Research Prize Merck Serono 2012 from the Salud 2000 Foundation and by a grant from ALK‐Abelló Laboratories. Additional data was received from the study authors (Ibanez Sandin MD 2017 [pers comm]) |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Participants were assigned to groups using a computer‐generated randomization table. |
Allocation concealment (selection bias) | Unclear risk | No information provided |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Unblinded intervention |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Unblinded intervention |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All outcomes accounted for and low level of attrition bias |
Selective reporting (reporting bias) | Unclear risk | Study protocol not available |