Safety and Efficacy of Very Low‐Dose Multi‐Nut Oral Immunotherapy in Children
Bibliographic record
Abstract
BACKGROUND: Oral immunotherapy (OIT) is a management strategy for food allergies, typically one at a time, with maintenance doses ≥ 300 mg protein. However, 30% of allergic children have multiple trigger foods, and large maintenance doses are associated with side effects. If efficacious, Very Low-Dose OIT (VLOIT) may enhance safety in multi-OIT. METHODS: Eighteen children with allergies to 2-5 nuts (tree nuts, peanuts) were enrolled (NCT03799328). Oral food challenge (OFC)-confirmed allergies to their nut mix at ≤ 444 mg protein each nut followed by initiation of an open-label mix of 4 mg protein/nut with dose increases every 2 months up to a maintenance dose of 30 mg protein/nut. After 18 months, an exit-OFC assessed allergic threshold changes, with a maximum of 2040 mg protein/nut. Efficacy was evaluated using pre-post treatment and proportional analyses (Wilcoxon signed-ranks, two-tailed Fisher's test). RESULTS: The median age at enrollment was 5.0 years (IQR 3.13-9.62). The baseline median tolerated dose was 10 mg protein/nut (IQR 3-100 mg). Three withdrew, one did not reach the target maintenance but was invited for the exit OFC, resulting in 15/18 eligible for exit OFC. The median tolerated dose at exit OFC was 1000 mg (IQR 300-1000 mg), with a significant difference from baseline (p < 0.0001). Ten out of 15 participants tolerated the maximum dose (p < 0.0001). Intention-to-treat analysis showed that 14/18 children met pre-defined efficacy measures: tolerated 5X their baseline dose or ≥ 300 mg (p < 0.001). No patients required epinephrine during treatment. CONCLUSIONS: VLOIT led to a significant increase in the tolerated dose to multiple nuts.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".