Protocol design for the ACTIVATE clinical trial: Exposure to vaginal microbiome in cesarean-delivered infants at high risk for allergies
Bibliographic record
Abstract
Background: Food allergy is increasingly common in the United States. Studies suggest that rising cesarean delivery rates are associated with many immune disorders, including allergic diseases. A preceding proof-of-concept study showed that the microbiota of infants born by cesarean delivery could be partially restored via vaginal microbiome exposure at birth via "vaginal seeding". Objectives: Described here is the design of a clinical trial to evaluate the effects of vaginal seeding in infants born by cesarean delivery on food allergen sensitization (egg, milk, and peanut) at 12 months of age. Methods: This study is supported by the Immune Tolerance Network in collaboration with the National Institute of Allergy and Infectious Diseases. ACTIVATE is a single-center, randomized, double-blind, placebo-controlled trial enrolling pregnant women and their newborns who have a first-degree relative with atopic disease (NCT03567707). Forty infants born vaginally and 80 infants born by cesarean delivery, randomized 1:1 to receive vaginal or placebo seeding, will be enrolled. Families are followed for 1 year, with an option to extend the follow-up for a total of 3 years. Results: The study is currently underway with an enrollment goal of 120 mother-infant pairs. Surveys and samples are collected from mothers and infants during the follow-up period including blood, stool, skin swabs, oral swabs, nasal swabs, maternal vaginal swabs, and breast milk. Conclusions: This pilot study will provide important data on the effects of vaginal seeding on allergen sensitization, the microbiome, and the development of immune responses in the first 3 years of life.
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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 | 0.002 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 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 | 0.001 | 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".