12 13 Unpredictability of symptoms from unintentional ingestion cause significant psychological distress and reduced health-related quality of life for patients and their families. Accidental ingestion is common, causing frequent and sometimes severe reactions. Management involves avoidance of the food concerned, provision of an epinephrine autoinjector in some cases, and early recognition of allergic symptoms and initiation of appropriate emergency treatment. There is currently no effective long-term treatment to modify the natural history of food allergy. 5–7 Moreover, peanut is one of the the most common causes of anaphylaxis 8 and death 9–11 from food allergy. 3 4 Peanut allergy affects 2% of children and is usually lifelong. Now affecting 8% 1 of children and 10% of infants, 2 food allergy is a significant public health problem in Western countries. The prevalence of food allergy in the paediatric population has risen exponentially in recent decades. Here we describe the protocol for a Phase IIb multicentre, double-blind, randomised, controlled trial (PPOIT-003) with dual primary objectives to evaluate the effectiveness of PPOIT at inducing SU (assessed at 8 weeks after treatment cessation) compared with placebo treatment and peanut OIT alone, in children with peanut allergy. We have previously shown that a novel treatment comprising a combination of the probiotic Lactobacillus rhamnosus CGMCC 1.3724 with peanut OIT (Probiotic Peanut Oral ImmunoTherapy (PPOIT)) is highly effective at inducing SU, with benefit persisting to 4 years after treatment cessation in the majority of initial treatment responders. Allergen oral immunotherapy (OIT) is a promising approach, which is effective at inducing desensitisation however, OIT has a limited ability to induce sustained unresponsiveness (SU). There is a pressing need for definitive treatments that improve the quality of life and prevent fatalities. There is currently no effective long-term treatment. The bottom line is that with Prota-lyn, Sci-Fit now have a revolutionary form of protein which is buffered against the harsh environment of the stomach and engineered into shorter peptide chains to allow for the highest rate of absorption of any protein on the planet.Peanut allergy is the the most common cause of life-threatening food-induced anaphylaxis. This creates new "hybrid peptides" which are easily digested by the stomach. The new patented process referred to as "Hybrid Enzymatic Peptide Enzyme Technology" is used to literally alter the long protein peptides on a molecular level. This alone produces a product, which is superior to all other forms of protein, and that's not all. To create Prota-lyn, first, long chain amino peptides are extracted from a milk and grain protein combination. While creating a protein which is pH buffered is a marvel all on its own, the process used to create this "perfect protein" is extremely complex and proprietary. In their continued mission to offer superior, patented products, Sci-Fit has developed the first pH buffered enhanced absorption protein, Prota-lyn. Sci-Fit's Prota-Lyn is a scientifically advanced perfect protein.
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