Study Supports Real Grocery Store Food for Safe, Accessible Sublingual Immunotherapy

A study found using real grocery store food for sublingual immunotherapy is a safe and effective way to expand the treatment’s feasibility and accessibility.1

“At our site, patient-reported adherence and satisfaction with real food [sublingual immunotherapy] was high,” wrote investigators, led by Brock W. Williams, PhD, from The University of British Columbia, in Vancouver, Canada. “In clinical settings where grocery-sourced real food products are used in [sublingual immunotherapy] solutions using clear protocols, the creation of a registry and publication of clinical outcomes may help further demonstrate the safety and effectiveness of these preparations.”

Typically, sublingual immunotherapy exposes patients to their food allergens in the form of pharmaceutical glycerinated food extracts. Clinical trials have demonstrated the effectiveness and safety of sublingual immunotherapy using these extracts—not with real food.2 However, relying on food extracts for this therapy limits accessibility due to the cost and availability.

Investigators sought to evaluate the effectiveness and safety of sublingual immunotherapy using real food from grocery stores, bypassing the extracts entirely.1 The primary outcome of the study was to develop protocols and resources for the preparation of real grocery store food for sublingual immunotherapy solutions. They also sought to describe patients’ experience with sublingual immunotherapy that uses real food.

The team developed 3 and 5-dose build-up protocols using powdered or liquid-based forms of food allergens available in Canada through local or online food retailers. The 5-dose build-up was intended for patients with severe features, such as a history of intravenous epinephrine infusion, intensive care unit admission, or oral food challenge threshold of < 1 mg of protein.

Protocols were developed for 31 foods, such as peanut, cow’s milk, cashew, egg, sesame, walnut, pecan, hazelnut, almond, pea, chickpea, lentil, salmon, wheat, barley, buckwheat, coconut, cod, corn, macadamia, mustard, rye, soy, and sunflower seeds. The protocol stated the maintenance dose was 2 – 4 mg of protein a day.

“These protocols are designed to offer busy allergy clinicians with detailed, step-by-step guidance to facilitate ease of use in clinical practice,” investigators wrote. “While the developed protocols use food products available in Canada and are based on Canadian Nutrition Facts labels, they can be easily adaptable in other contexts, so long as the protein concentration per serving size is known.”

Investigators then collected data on patient adherence (months 6, 12, 18, and 24) and satisfaction (weeks 8 – 16) through online surveys. Following 1 – 2 years of sublingual immunotherapy with real food, patients could decide if they wanted to complete a low-dose oral food challenge at 330 – 340 mg of protein a day.

The study included 305 patients who underwent or are still undergoing, real food sublingual immunotherapy. Among the 162 patients who completed the therapy, an overwhelmingly high percentage of participants (99%; n = 160) reported being satisfied or very satisfied with the treatment. The adherence survey revealed that 82% of participants reported consistently taking their sublingual immunotherapy dose.

At the time of the report, 33 patients had a completed oral food challenge, with a total of 57 low-dose oral food challenges performed. Among these challenges, 70.1% (n = 40) were successful.

“Prior to the initiation of [sublingual immunotherapy], allergists should consider the relative indications and contraindications outlined to ensure safe provision of this therapy. Informed consent and shared decision-making with patients and their caregivers are also required before proceeding with food [sublingual immunotherapy] in clinical practice, recognizing that real food [sublingual immunotherapy] might not be practical or manageable for every patient or caregiver. If a patient is undergoing multi-food [sublingual immunotherapy], we have observed that managing up to 5 allergens appears to be the practical maximum for families, beyond which the process may become overly challenging or burdensome.”

References

1. Williams BA, Baaske A, Soller L, Erdle SC, Wong T, Mak R, Schroeder ND, Chan ES. The use of grocery-sourced real food solutions in sublingual immunotherapy for food allergies. Ann Allergy Asthma Immunol. 2025 Mar 8:S1081-1206(25)00116-4. doi: 10.1016/j.anai.2025.03.001. Epub ahead of print. PMID: 40064397.

2. Soller L, Williams BA, Mak R, Wong T, Erdle SC, Chomyn A, Tetreault B, Morrison K, Gaudet L, Chan ES. Safety and Effectiveness of Bypassing Oral Immunotherapy Buildup With an Initial Phase of Sublingual Immunotherapy for Higher-Risk Food Allergy. J Allergy Clin Immunol Pract. 2024 May;12(5):1283-1296.e2. doi: 10.1016/j.jaip.2024.02.024. Epub 2024 Feb 27. PMID: 38423293.