{"doi":"10.1016/j.jacig.2025.100558","title":"Protocol design for the ACTIVATE clinical trial: Exposure to vaginal microbiome in cesarean-delivered infants at high risk for allergies","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.","journal":"Journal of Allergy and Clinical Immunology Global","year":2025,"id":536566,"datarank":0.0,"base_score":0.0,"endowment":0.0,"self_citation_contribution":0.0,"citation_network_contribution":0.0,"self_endowment_contribution":0.0,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":1,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9449,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2025-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":615340,"name":"Sharon A. Chung","orcid":"0000-0002-2238-2287","position":1,"is_corresponding":false},{"id":303359,"name":"Lisa M. Wheatley","orcid":null,"position":2,"is_corresponding":false},{"id":1421900,"name":"Audrey Plough","orcid":null,"position":3,"is_corresponding":false},{"id":1128440,"name":"Joy Laurienzo Panza","orcid":null,"position":4,"is_corresponding":false},{"id":465641,"name":"Michelle L. Sever","orcid":"0000-0002-2435-1214","position":5,"is_corresponding":false},{"id":1123692,"name":"Angela Bianco","orcid":null,"position":6,"is_corresponding":false},{"id":1096355,"name":"Noel Strong","orcid":null,"position":7,"is_corresponding":false},{"id":274002,"name":"M. Cecilia Berin","orcid":"0000-0002-9051-9249","position":8,"is_corresponding":false},{"id":29060,"name":"José C. Clemente","orcid":"0000-0002-3970-9856","position":9,"is_corresponding":false},{"id":273996,"name":"Hugh A. Sampson","orcid":"0000-0003-1613-8875","position":10,"is_corresponding":false},{"id":1095929,"name":"Angela Tsuang","orcid":"0000-0002-9304-0604","position":0,"is_corresponding":true}],"reference_count":37,"raw_metadata":null,"created_at":"2026-07-19T02:52:05.227140Z","pmid":"41018687","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}