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Effectiveness and safety of the four-step versus six-step milk ladder in children with IgE-mediated cow's milk protein allergy: protocol for an open-label randomised controlled trial

Wiszniewska, Daria; Horvath, Andrea; Stróżyk, Agata; Nowak-Wegrzyn, Anna; Grzela, Katarzyna; Szajewska, Hanna
INTRODUCTION/BACKGROUND:Introducing baked milk into the diet of children with cow's milk protein allergy (CMPA) has been shown to potentially accelerate the development of tolerance to non-heated milk. However, there is no standardised milk ladder (ML) protocol, and different scientific societies across countries recommend varying versions. This study aims to assess the effectiveness and safety of the four-step ML (4-ML) compared with the six-step ML (6-ML) in children with IgE-mediated CMPA. METHODS AND ANALYSIS/METHODS:We will perform an open-label randomised trial with two parallel arms in two departments of the same academic hospital. A total of 92 children with IgE-mediated CMPA will be allocated in a 1:1 ratio to introduce cow's milk into their diet according to either 4-ML or 6-ML with a 4-week break period between subsequent steps. Oral food challenge (OFC) with tested products at each subsequent step of the ML will be conducted in hospital settings. The primary outcome will be the percentage of children with tolerance to non-heated cow's milk proteins defined as no allergic reaction to raw cow's milk (120-240 mL depending on the age of the patient) during the last OFC; measured at the end of the 12-week observation period for the 4-ML and 20-week observation period for the 6-ML. Secondary outcomes will include the percentage of children with a negative OFC to each ML step; the percentage of children with anaphylaxis (both those who were treated and those who were not treated with epinephrine); the percentage of children with exacerbation of atopic dermatitis; growth; compliance; and quality of life of the caregivers and parents' anxiety about adverse events during their child's OFC. ETHICS AND DISSEMINATION/BACKGROUND:The bioethics committee of the Medical University of Warsaw, Poland, approved this protocol (KB/107/2024). The findings will be published in a peer-reviewed journal and submitted to relevant conferences no later than 1 year after data collection. TRIAL REGISTRATION NUMBER/BACKGROUND:NCT06664918.
PMCID:11997811
PMID: 40228856
ISSN: 2044-6055
CID: 5827582

Introduction [Editorial]

Brar, Kanwaljit K; Nowak-Wegrzyn, Anna
PMID: 40204560
ISSN: 1538-3199
CID: 5823952

Assessing Protocol Variability for Food Protein-Induced Enterocolitis Syndrome Oral Food Challenges

Anvari, Sara; Banerjee, Ankona; Leonard, Stephanie; Gonzalez-Delgado, Purificacion; Nguyen, Duc T; Nowak-Wegrzyn, Anna
PMID: 39542210
ISSN: 2213-2201
CID: 5753602

Are we a step closer to giving patients with food protein-induced enterocolitis syndrome and caregivers what they want? [Editorial]

Bingemann, Theresa A; Bauer, Maureen; Nowak-Wegrzyn, Anna
PMID: 39909650
ISSN: 1534-4436
CID: 5784092

Management of children with food allergies by allergists in the United States

Anagnostou, Aikaterini; Greenhawt, Matthew; Lieberman, Jay A; Ciaccio, Christina E; Sindher, Sayantani B; Creasy, Blaine; Baran, Katherine; Gupta, Sachin; Nowak-Wegrzyn, Anna
BACKGROUND/UNASSIGNED:Management of patients with food allergies is complex, especially in cases of patients with multiple and potentially severe food allergies. Although international guidelines exist for food allergy management, the role of the allergist in the decision-making process is key. OBJECTIVE/UNASSIGNED:Our aim was to investigate the management patterns and educational needs of practicing allergists treating patients with food allergies. METHODS/UNASSIGNED:An online survey was e-mailed to United States-based practicing allergists (N = 2833) in November-December 2021. The allergists were screened for managing 1 or more patients (including ≥25% pediatric patients) with food allergies per month. The allergists responded to questions regarding food allergy management in response to 2 hypothetical pediatric case studies, their familiarity with available guidelines and emerging treatments, and their future educational preferences. A descriptive analysis of outcomes was conducted. RESULTS/UNASSIGNED:A total of 125 responding allergists (4.4%) met the eligibility criteria and completed the survey. The allergists prioritized written exposure action plans, patient-caregiver communication, prevention of serious reactions, and consideration of both food allergy severity and allergic comorbidities in the management of patients with food allergies. With regard to recommending biologics in the future, the allergists identified patient history of anaphylaxis and hospitalizations, food allergy severity, and allergic comorbidities as all being important factors to consider when deciding on appropriate treatment options. The allergists noted their ongoing educational needs, especially for current and emerging treatments for food allergies. CONCLUSION/UNASSIGNED:With the treatment landscape for food allergies evolving rapidly, the decision-making priorities and continuing educational needs of allergists will be important in optimizing the management of patients with food allergies.
PMCID:11750536
PMID: 39844911
ISSN: 2772-8293
CID: 5802402

Current status and future directions in Food Protein-Induced Enterocolitis Syndrome (FPIES): An NIAID Workshop Report

Nowak-Wegrzyn, Anna; Sicherer, Scott H; Akin, Cem; Anvari, Sara; Bartnikas, Lisa M; Berin, M Cecilia; Bingemann, Theresa A; Boyd, Scott; Brown-Whitehorn, Terri; Bunyavanich, Supinda; Cianferoni, Antonella; du Toit, George; Fortunato, John E; Goldsmith, Jeffrey D; Groetch, Marion; Leonard, Stephanie A; Rao, Meenakshi; Schultz, Fallon; Schwaninger, Julie M; Venter, Carina; Westcott-Chavez, Amity; Wood, Robert A; Togias, Alkis
Food Protein-Induced Enterocolitis (FPIES) is a non-IgE mediated GI food allergy characterized by delayed, protracted vomiting, accompanied by lethargy and pallor, usually 1-4 hours following ingestion of the food allergen. The pathophysiology of FPIES remains unknown and currently there are no diagnostic biomarkers available to assess disease activity or its resolution. Over the last two decades, FPIES has become increasingly recognized in both pediatric and adult patients. Forty years later after the initial FPIES description, the first international classification of diseases (ICD-10) code for FPIES was established and the first international consensus guidelines for diagnosis and management of FPIES was published. On June 22, 2022, the National Institute of Allergy and Infectious Diseases (NIAID) held its first virtual multidisciplinary workshop on FPIES. Various clinical and translational aspects of FPIES, as well as the important areas of unmet needs were discussed as priorities for future research during this 2-day virtual workshop. The following report provides a summary of content of the workshop, including updated literature on the topic areas, as well as providing a critical commentary on the state of FPIES.
PMID: 39521282
ISSN: 1097-6825
CID: 5752372

The use and implementation of omalizumab as food allergy treatment: Consensus-based guidance and Work Group Report of the Adverse Reactions to Foods Committee of the American Academy of Allergy, Asthma & Immunology

Anagnostou, Aikaterini; Bird, J Andrew; Chinthrajah, Sharon; Dribin, Timothy E; Fleischer, David M; Kim, Edwin; Nowak-Wegrzyn, Anna; Rachid, Rima; Shaker, Marcus S; Shreffler, Wayne; Sicherer, Scott; Tam, Jonathan; Vickery, Brian P; Virkud, Yamini V; Wang, Julie; Young, Michael; Greenhawt, Matthew
Omalizumab was recently approved by the US Food and Drug Administration for treatment of any single food allergy or multiple food allergies in children aged 1 year and older and adults. There is currently no formal guidance regarding recommended best practices for omalizumab use in food allergy, including patient selection, anticipated goals and outcomes of therapy, procedure for monitoring patients who elect to start omalizumab therapy, and ways in which omalizumab can be incorporated into the landscape of food allergy management and daily clinical practice. This work group report was developed by the food allergy therapies subcommittee of the Adverse Reactions to Foods Committee within the American Academy of Allergy, Asthma & Immunology. Consensus, evidence-based guidance regarding experts' recommendations for using omalizumab to treat children and adults with food allergy was developed by using modified Delphi methodology. In iterative fashion, a total of 8 statements regarding how to use omalizumab to treat patients with food allergy were developed by 16 clinical experts. This guidance provides the clinician with a suggested approach to patient selection, initiation of therapy, monitoring of efficacy, and long-term follow-up care. The role of preference-sensitive care is emphasized, with most statements offering care recommendations relevant to the culture and values of a particular practice setting.
PMID: 39580718
ISSN: 1097-6825
CID: 5775212

Baked milk diet is associated with improved quality of life and growth parameters in milk-allergic children [Letter]

Wong, Lydia Su Yin; Groetch, Marion; Bahnson, Henry T; Strong, Elizabeth; Nowak-Wegrzyn, Anna; Sampson, Hugh A
PMID: 39382844
ISSN: 1398-9995
CID: 5706112

An Algorithm for the Diagnosis and Treatment of Food Protein-Induced Enterocolitis Syndrome (FPIES), 2024 Update

Beaudoin, Michele; Mehra, Ashna; Wong, Lydia Su Yin; Vazquez-Ortiz, Marta; González-Delgado, Purificación; Nowak-Wegrzyn, Anna
PMID: 39655844
ISSN: 1398-9995
CID: 5762522

An International Delphi Consensus on the Management of Pollen-Food Allergy Syndrome: A Work Group Report of the AAAAI Adverse Reactions to Foods Committee

Al-Shaikhly, Taha; Cox, Amanda; Nowak-Wegrzyn, Anna; Cianferoni, Antonella; Katelaris, Constance; Ebo, Didier G; Konstantinou, George N; Brucker, Hannelore; Yang, Hyeon-Jong; Protudjer, Jennifer L P; Boechat, José Laerte; Yu, Joyce E; Wang, Julie; Hsu Blatman, Karen S; Blazowski, Lukasz; Anand, Mahesh Padukudru; Ramesh, Manish; Torres, Maria J; Holbreich, Mark; Goodman, Richard; Wasserman, Richard L; Hopp, Russell; Sato, Sakura; Skypala, Isabel
BACKGROUND:Pollen-food allergy syndrome (PFAS) is common among patients with allergic rhinitis. Treatment recommendations for patients with PFAS remain variable. OBJECTIVE:To develop consensus recommendation statements for managing patients with PFAS. METHODS:An international panel of allergists, researchers, and nutritionists with an interest in PFAS from 25 different institutions across 11 countries convened and a list of statements was written by 3 authors. The RAND/University of California Los Angeles methodology was adopted to establish consensus on the statements. RESULTS:After 2 Delphi rounds, a consensus was reached on 14 statements. The panel agreed that patients with PFAS would benefit from counseling on the nature and basis of PFAS and the rare chance of more severe systemic reactions and their recognition. The panel agreed on avoiding the raw food responsible for the index reaction, but not potentially cross-reactive fruits/vegetables based on the responsible food of the index reaction. Epinephrine autoinjectors should be recommended for patients with PFAS who experienced severe symptoms (beyond the oropharynx) or for patients considered at risk for severe reactions. The panel agreed that the benefit of allergen immunotherapy remains unclear and that PFAS should not be considered the primary indication for such intervention. CONCLUSIONS:We developed consensus statements regarding counselling patients about the nature and severity of PFAS, potential risk factors, dietary avoidance, epinephrine autoinjector prescription, and allergen immunotherapy consideration for patients with PFAS.
PMCID:11625607
PMID: 39488768
ISSN: 2213-2201
CID: 5763852