Trial reportThe Journal of allergy and clinical immunology2012
The safety and efficacy of sublingual and oral immunotherapy for milk allergy.
Trial report in The Journal of allergy and clinical immunology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03462030 (Phase II Study of Baked Milk Oral Immunotherapy for the Treatment of Cow's Milk Allergy), which is not on this map. Cited by 151 papers, 5 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Phase II Study of Baked Milk Oral Immunotherapy for the Treatment of Cow's Milk Allergy
Who cites it
151 citing papers in PubMed, 5 syntheses or guidelines pooled it, 421 citations in OpenAlex.
- Epithelial immunotherapy for food allergy in children: a systematic review and meta-analysis.Frontiers in immunology · 2024Pooled it
- Allergen immunotherapy and/or biologicals for IgE-mediated food allergy: A systematic review and meta-analysis.Allergy · 2022Pooled it
- Peanut Can Be Used as a Reference Allergen for Hazard Characterization in Food Allergen Risk Management: A Rapid Evidence Assessment and Meta-Analysis.The journal of allergy and clinical immunology. In practice · 2022Pooled it
- Immunotherapy (oral and sublingual) for food allergy to fruits.The Cochrane database of systematic reviews · 2015Pooled it
- Oral immunotherapy for milk allergy.The Cochrane database of systematic reviews · 2012Pooled it
- Clinical and immunological outcomes after randomized trial of baked milk oral immunotherapy for milk allergy.JCI insight · 2025Trial
- Double-Blind, Placebo-Controlled Study of E-B-FAHF-2 in Combination With Omalizumab-Facilitated Multiallergen Oral Immunotherapy.The journal of allergy and clinical immunology. In practice · 2023Trial
- Retail Food Equivalents for Post-Oral Immunotherapy Dosing in the Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen Oral Immunotherapy in Food-Allergic Children and Adults (OUtMATCH) Clinical Trial.The journal of allergy and clinical immunology. In practice · 2023Trial
- Sustained successful peanut oral immunotherapy associated with low basophil activation and peanut-specific IgE.The Journal of allergy and clinical immunology · 2020Trial
- Long-term sublingual immunotherapy for peanut allergy in children: Clinical and immunologic evidence of desensitization.The Journal of allergy and clinical immunology · 2019Trial
- Predicting development of sustained unresponsiveness to milk oral immunotherapy using epitope-specific antibody binding profiles.The Journal of allergy and clinical immunology · 2019Trial
- High- and low-dose oral immunotherapy similarly suppress pro-allergic cytokines and basophil activation in young children.Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology · 2019Trial
- Mechanistic correlates of clinical responses to omalizumab in the setting of oral immunotherapy for milk allergy.The Journal of allergy and clinical immunology · 2017Trial
- Food-specific sublingual immunotherapy is well tolerated and safe in healthy dogs: a blind, randomized, placebo-controlled study.BMC veterinary research · 2017Trial
- A randomized, double-blind, placebo-controlled study of omalizumab combined with oral immunotherapy for the treatment of cow's milk allergy.The Journal of allergy and clinical immunology · 2016Trial
- A randomized, double-blind, placebo-controlled pilot study of sublingual versus oral immunotherapy for the treatment of peanut allergy.The Journal of allergy and clinical immunology · 2015Trial
- Sublingual immunotherapy for peanut allergy: Long-term follow-up of a randomized multicenter trial.The Journal of allergy and clinical immunology · 2015Trial
- Distinct parameters of the basophil activation test reflect the severity and threshold of allergic reactions to peanut.The Journal of allergy and clinical immunology · 2015Trial
- Modulation of dendritic cell innate and adaptive immune functions by oral and sublingual immunotherapy.Clinical immunology (Orlando, Fla.) · 2014Trial
- A pilot study of omalizumab to facilitate rapid oral desensitization in high-risk peanut-allergic patients.The Journal of allergy and clinical immunology · 2013Trial
91 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 3 institutions in 1 country.
Funding
Abstract
backgroundOral immunotherapy (OIT) and sublingual immunotherapy (SLIT) are potential therapies for food allergy, but the optimal method of administration, mechanism of action, and duration of response remain unknown.
objectiveWe sought to explore the safety and efficacy of OIT and SLIT for the treatment of cow's milk (CM) allergy.
methodsWe randomized children with CM allergy to SLIT alone or SLIT followed by OIT. After screening double-blind, placebo-controlled food challenges and initial SLIT escalation, subjects either continued SLIT escalation to 7 mg daily or began OIT to either 1000 mg (the OITB group) or 2000 mg (the OITA group) of milk protein. They were challenged with 8 g of milk protein after 12 and 60 weeks of maintenance. If they passed the 60-week challenge, therapy was withdrawn, with challenges repeated 1 and 6 weeks later. Mechanistic correlates included end point titration skin prick testing and measurement of CM-specific IgE and IgG(4) levels, basophil histamine release, constitutive CD63 expression, CD203c expression, and intracellular spleen tyrosine kinase levels.
resultsThirty subjects with CM allergy aged 6 to 17 years were enrolled. After therapy, 1 of 10 subjects in the SLIT group, 6 of 10 subjects in the SLIT/OITB group, and 8 of 10 subjects in the OITA group passed the 8-g challenge (P = .002, SLIT vs OIT). After avoidance, 6 of 15 subjects (3 of 6 subjects in the OITB group and 3 of 8 subjects in the OITA group) regained reactivity, 2 after only 1 week. Although the overall reaction rate was similar, systemic reactions were more common during OIT than during SLIT. By the end of therapy, titrated CM skin prick test results and CD63 and CD203c expression decreased and CM-specific IgG(4) levels increased in all groups, whereas CM-specific IgE and spontaneous histamine release values decreased in only the OIT group.
conclusionOIT was more efficacious for desensitization to CM than SLIT alone but was accompanied by more systemic side effects. Clinical desensitization was lost in some cases within 1 week off therapy.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.