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WO2024085750A1 - Prévention des allergies aux noix et aux graines chez l'être humain - Google Patents

Prévention des allergies aux noix et aux graines chez l'être humain Download PDF

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Publication number
WO2024085750A1
WO2024085750A1 PCT/NL2023/050534 NL2023050534W WO2024085750A1 WO 2024085750 A1 WO2024085750 A1 WO 2024085750A1 NL 2023050534 W NL2023050534 W NL 2023050534W WO 2024085750 A1 WO2024085750 A1 WO 2024085750A1
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WO
WIPO (PCT)
Prior art keywords
composition
gram
seed
dose
tree nut
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Ceased
Application number
PCT/NL2023/050534
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English (en)
Inventor
Laurie LANCEE
Jozien BOERSMA
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Vini Mini BV
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Vini Mini BV
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Vini Mini BV filed Critical Vini Mini BV
Publication of WO2024085750A1 publication Critical patent/WO2024085750A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/17—Amino acids, peptides or proteins
    • A23L33/185—Vegetable proteins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/22—Anacardiaceae (Sumac family), e.g. smoketree, sumac or poison oak
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/52—Juglandaceae (Walnut family)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/35—Allergens
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/08—Antiallergic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/545—Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule

Definitions

  • the present invention relates to a composition for use in the prevention, reduction and/or treatment of tree nut and seed allergy in humans. Furthermore, the invention provides methods for prevention, reduction and/or treatment of tree nut allergy and/or seed allergy in humans. BACKGROUND OF THE INVENTION Tree nut allergies and seed allergies are a worldwide phenomenon and its prevalence is increasing over the years. A worldwide prevalence for tree nut allergy has been reported of up to 4.9% of the general population. Peanut allergy is one of the most well-known tree nut and seed allergies.
  • Tree nut and seed allergies can have a serious impact on the quality of life of humans, both adults and children.
  • symptoms can vary in severity and may be mild to moderate such as gastrointestinal problems including abdominal pain and diarrhoea, and/or other symptoms such as itching and cutaneous rash, or can be more severe i.e. respiratory problems, there is also the risk for an anaphylactic shock which can have fatal consequences.
  • the impact on the quality of life of the patients is mainly affected by this continuous treat, and the daily consideration with food intake.
  • the most common underlying mechanism is an immune response to the tree nut and seed allergens causing an immunoglobulin E (IgE) mediated reaction.
  • the allergen is the food protein of the tree nuts and seeds.
  • the immune response is associated with the release of histamine.
  • current treatment i.e. antihistamine drugs
  • More serious symptoms can be treated with adrenaline.
  • adrenaline With anaphylactic shock the body is making adrenaline as a natural antidote.
  • adrenaline is given as a medication to enhance this natural defend mechanism of the body.
  • Tree nuts and seeds allergies can be prevented in the majority of cases (about 80%) by early intervention of allergen exposure.
  • the current guidelines in The Netherlands from the Dutch Association of Pediatrics (Nederlandse Vereniging voor Kindergeneestechnik, NVK) recommends an exposure in babies before the age of 8 months, most likely in the age between 4 and 8 months of age, although later exposure can still be helpful too if that time window has been passed.
  • NVK Dutch Association of Pediatrics
  • There are different introduction schemes available to get children and adults familiar with tree nuts and seeds for example schemes for peanuts, cashews, pistachios and walnuts.
  • a first aspect of the present invention relates to a composition for use in preventing, reducing and/or treating of allergy against a tree nut and/or seed in humans.
  • the weight of the protein of the tree nut and/or the seed of the composition is between 0.1 – 100%.
  • the composition is administered at intervals of at least one hour in a series of 3 – 6 dose increment steps from an initial dose to a maximum dose.
  • the dosages comprise 0.01 – 5 gram, preferably 1 – 5 gram, or preferably 0.01 – 4 gram of said composition and each dose is administered in 1 to 3 consecutive portions.
  • the present inventors established that a desired dose of protein of tree nut and/or seed can be reached with the current invention.
  • a second aspect of the present invention relates to a composition of protein of 1 – 6 tree nut(s) and/or protein of 1 – 6 seed(s).
  • the weight of a protein of the tree nut(s) and/or the seed(s) of the composition is between 0.1 – 100%.
  • the tree nut and/or seeds are preferably selected from cashews, hazelnuts, peanuts, walnuts, almonds, and pistachios, more preferably from cashews, hazelnuts, peanuts, and walnuts, even more preferably form cashews, hazelnuts, and walnuts, such as cashews and/or hazelnuts and/or walnuts.
  • a third aspect of the present invention relates to a kit for use in preventing, reducing and/or treating of allergy against a tree nut and/or seed in humans.
  • the weight of a protein of the tree nut and/or the seed of the composition between 0.1 – 100%.
  • the tree nut and/or seeds are preferably selected from cashews, hazelnuts, peanuts, walnuts, almonds, and pistachios, preferably from cashews, hazelnuts, walnuts, almonds, and pistachios, or from peanuts, more preferably, from cashews, hazelnuts, and walnuts, such as cashews and/or hazelnuts and/or walnuts.
  • the dosages comprise 0.01 – 4 gram of said composition.
  • allergy as used herein has its conventional meaning and refers to the condition of an immune response to tree nut and/or seed allergens.
  • carrier refers to an adjuvant, diluent, excipient or vehicle with which the protein of the tree nut and/or the seed is administered.
  • carrier can be a flour such as tapioca flour.
  • composition can also be an edible carrier, such as a fruit composition or vegetable composition.
  • composition refers to a nutritional composition.
  • the composition contains a protein of a tree nut and/or seed.
  • dose refers to a single amount of intake of the composition. This can be administered once or on a more regular basis such as a weekly basis.
  • human subject refers to the general population, not specifically a human subject suffering from a disease but that is not a limitation either.
  • the human subject is a child.
  • a child in the range of 4 – 24 months of age, more preferably 4 – 14 months of age, most preferably 4 – 8 months of age.
  • the invention is particularly useful for children who are at risk for tree nut and/or seed allergy such as children who have allergies for other (food) allergens, eczema or other signs of immune deficiencies, but the definition of “human subject” is not limited by any (such) theory.
  • portion refers to the amount of the composition being eating at one time containing a portion size in the range of 1 – 10 gr. More specifically, as it is most likely that the portion will be administered orally using a spoon, the portion is expect to be the size that fits to a spoon. For children and babies this is on average about 3 – 5 gr.
  • the term “tree nut” as used herein refers to any edible tree nut belonging to one of the five orders of plants: beech (Fagales), soapwood (Sapindales), silverberry (Proteales), heather (Ericales), and rosewood (Rosales).
  • this includes but is not limited to almonds, Brazil nuts, cashews, chestnuts, hazelnuts, macadamia nuts, pecans, pistachios, and walnuts.
  • the tree nuts are selected from cashews, hazelnuts, peanuts, walnuts, almonds, and pistachios, and more preferably cashews, hazelnuts, peanuts, and walnuts, and most preferably cashews, hazelnuts, and walnuts.
  • seed refers to a general, wider meaning of edible seeds. Which means the seed can also refer to the fruit or seed of a legume.
  • the seed is selected from peanuts, pine nuts, sesame seeds, and soybeans, and more preferably the seed is a peanut.
  • “And/or” where used herein is to be taken as specific disclosure of each of the two specified features or components with or without the other.
  • “A and/or B” is to be taken as specific disclosure of each of “A”, “B”, “A and B”.
  • “A”, “an”, and “the” as used herein refer to both singular and plural forms unless the context clearly dictates otherwise.
  • a compartment refers to one or more than one compartment.
  • brackets usually means that the term within brackets specifies a possible option or a possible meaning and should thus not be considered limiting.
  • the embodiments of the invention described herein can operate in combination and cooperation, unless specified otherwise. Unless otherwise defined, all terms used in disclosing the invention, including technical and scientific terms, have the meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.
  • a first aspect of the present invention relates to a composition for use in preventing, reducing and/or treating of allergy against a tree nut and/or a seed in a human subject, wherein said composition comprises 0.1 – 100% by weight of a protein of the tree nut and/or the seed, and wherein said composition is administered to a human subject in need thereof at intervals of at least one hour in a series of 3 – 6 dose increment steps from an initial dose to a maximum dose and wherein the dosages comprise 0.01 – 5 gram, preferably 1 – 5 gram, or preferably 0.01 – 4 gram of said composition and wherein each dose is administered in 1 to 3 consecutive portions.
  • the weight of a protein of the tree nut and/or the seed of the composition is between 0.5 – 50%. Furthermore, the weight of a protein of the tree nut and/or the seed of the composition is between 0.5 – 50% with the addition of presence of a carrier.
  • the carrier may be a flour, preferably tapioca flour. The benefit of selecting a flour as a carrier is that it easily can be used in capsules, sachets or bags.
  • the composition may be formulated as a single unit dose, such as a capsule, sachet or a bag. However, the invention is not limited to such single unit dosages as there may be other formulations that are also easily transported and mixed with nutrition such as a container provided with for example a measuring cup.
  • compositions may be solutions or suspensions so that the invention may be present as a nutritional drink.
  • the dosages comprise 0.01 – 2 gram of above mentioned composition.
  • the composition is intended to be administered to children and/or babies.
  • the preferred age of the child is between 4 – 24 months of age, more preferably 4 – 14 months of age, most preferably 4 – 8 months of age. Although it is preferred to start as early as 4 months of age, it is still helpful to start at a later age after 1 year. As such, the broadest age range is defined from 4 to 24 months of age.
  • tree nuts and/or seeds that may be part of the invention including but not limited to almonds, Brazil nuts, cashews, chestnuts, hazelnuts, macadamia nuts, peanuts, pecans, pine nuts, pistachios, sesame seeds, soybeans, and walnuts.
  • the tree nut and/or the seed is selected from cashews, hazelnuts, peanuts, walnuts, almonds, and pistachios, more preferably cashews, hazelnuts, peanuts, and walnuts, most preferably, from cashews, hazelnuts, and walnuts, or from peanuts.
  • the dose is administered in one or two portions, preferably in one portion.
  • the dose increment steps are carried out in six increment steps.
  • the first four doses are administered on day 1 and the fifth and sixth doses are administered on day 2.
  • the dose increment steps range from 0.01 to 2.0 gram from an initial dose to a final dose.
  • the preferred dose increment steps are 0.01 gram, 0.03 gram, 0.1 gram, 0.3 gram, 1 gram, and 2 gram.
  • the composition is mixed with an edible carrier. This may be a fruit composition or a vegetable composition.
  • the composition comprises the protein of the tree nut and/or the seed and an edible carrier.
  • the dosage of the protein of the tree nut and/or the seed is at least 0.01 to 4 gram as mentioned in the embodiments above and the dosage of the carrier is at least 1 to 3 gram of a fruit or vegetable composition.
  • the doses that are mentioned in the above embodiments are provided as unit dose formulations that are separately packaged.
  • the composition is administered to children and/or babies.
  • the children and/or babies are between 4 – 24 months of age.
  • the dose increment steps range from 0.01 to 2.0 gram from an initial dose to a final dose.
  • the preferred dose increment steps are 0.01 gram, 0.03 gram, 0.1 gram, 0.3 gram, 1 gram, and 2 gram.
  • the present invention demonstrates that the exact dose of protein of tree nut and/or seed can be reached with the current composition.
  • a surprising effect of the present invention is the lower amount or volume of nutrition that is needed to reach a certain protein level in comparison with the more standard way of administering a tree nut and/or seed in a paste, which requires a higher volume to reach the same dose level and is often difficult to achieve in young children. It has surprisingly been found that intervention of allergen exposure to prevent, reduce and/or treat allergy against a tree nut and/or seed in humans can be done in multiple increment steps.
  • the composition in a small amount of portions, such as 1 to 3 consecutive portions, is expected to increase compliance and convenience of the allergen intake.
  • the preferred dose is 1 portion.
  • more than 1 portion might be needed with higher dose levels as the nutrition intake of one portion is restricted to the way of administration to the child or baby. Most likely, this is administered orally with a spoon which results in a portion size in the range of 1–10 gr, on average about 3 – 5 gr.
  • the tree nut and/or seed protein is most likely present in the form of flour. Tapioca flour may be added to the tree nut and/or seed flour as a carrier.
  • Flour is a convenient way to administer the protein of the tree nut and/or seed as it can easily be mixed with other food, such as a fruit or vegetable composition.
  • it can be stored in capsules, sachets and/or bags which can easily be transported to the customer.
  • the current invention demonstrates user convenience which helps to start at a very early age with tree nut and/or seed intake.
  • the current invention facilitates early intake of the tree nut and/or seed protein as early as the age of 4 months old.
  • the tree nut and/or seed can be given in combination with a carrier, which can be a fruit or vegetable composition that is generally appreciated by young children.
  • the fruit or vegetable composition can be selected from a composition that has been previously well tolerated by the child or baby. This differs from a paste (such as peanut butter) which may not have a familiar taste for young children and/or babies and can thus have a negative effect on compliance.
  • a second aspect of the present invention relates to a composition
  • a composition comprising 0.1 and 100% by weight of protein of 1 – 6 tree nut(s) and/or protein of 1 – 6 seed(s), wherein the tree nut and/or the seed are selected from cashews, hazelnuts, peanuts, walnuts, almonds, and pistachios, preferably from cashews, hazelnuts, peanuts, and walnuts, more preferably from cashews, hazelnuts, and walnuts, or from peanuts.
  • a further aspect of the present invention related to the composition, as described above for use in preventing, reducing and/or treating of allergy against tree nut(s) and/or a seed(s) in a human subject, wherein said composition is administered to a human subject in need thereof, wherein the dose comprises 1 – 5 gram of said composition and wherein each dose is administered once a week for a period of 3 – 12 months.
  • a weekly administration in the form of the invention e.g. as capsules, sachets and/or bags or a box comprising tree nut and/or seed flour, which can be sent by post, contributes to the convenience and compliance of the protein intake by humans, especially young children and babies.
  • a last aspect of the present invention relates to a kit for use in preventing, reducing and/or treating of allergy against a tree nut and/or a seed in a human subject, said kit comprising a composition that comprises 0.1 – 100% by weight of a protein of the tree nut and/or the seed, wherein the tree nut and/or the seed are selected from cashews, hazelnuts, peanuts, walnuts, almonds, and pistachios, preferably from cashews, hazelnuts, peanuts, and walnuts, more preferably from cashews, hazelnuts, and walnuts, or from peanuts, and wherein the dosages comprise 0.01 – 4 gram of said composition.
  • Example 1 Protein content of the 6 step increment
  • Table 1 shows the 6 step increment of administration of cashew, hazelnut, walnut and/or peanut protein.
  • the protein content is shown, as well as the corresponding amount of flour that is needed to reach that amount of protein.
  • the flour content varies because of the amount of protein may vary between the different tree nuts and/or seeds (protein %). Not only may the protein content vary between the different tree nuts and/or seeds, it also may vary within a tree nut and/or seed.
  • Table 2 shows a different amount of flour for cashew, hazelnut and walnut because of a higher range in protein content in comparison with the results from Table 1.
  • the carrier may be tapioca flour.
  • the amount of tapioca flour is shown for each step at (Table III).
  • the formulation is present in the form of capsules.
  • the flour content of the tree nut and/or seed protein and the tapioca flour are stored in the same capsule resulting in one capsule for each step.
  • the level of protein content is similar for the different tree nuts and/or seeds.
  • Table 5 shows a different amount of flour for cashew, hazelnut and walnut because of a higher range in protein content in comparison with the results from Table 4.
  • Table 4 Tree nut and/or seed flour content Tree nut and/or seed protein content (gram) (gram) Ste Formulati Hazeln Pean p on Cashew Hazelnut Walnut Peanut Cashew ut Walnut ut Protein 50.0 (%) 28.00 27.80 44,00 0 1 Sachet 0.30 0.30 0.30 0.30 0.30 1.07 1.08 0.68 0.60 2 Sachet 1.00 1.00 1.00 3.57 3.60 2.27 2.00 3 Sachet 2.00 2.00 2.00 2.00 7.14 7.19 4.55 4.00 Total protein 3.30 3.30 3.30 3.30 3.30 Table 5 Tree nut and/or seed flour content Tree nut and/or seed protein content (gram) (gram) Ste Formulati Cashe Hazeln Waln Pean p on Cashew Hazelnut Walnut Peanut w ut Walnut ut Protein 50.0 (%) 28.00 27.80 44,00
  • the protein content is shown, as well as the corresponding amount of flour that is needed to reach that amount of protein.
  • Table 7 shows a different amount of flour for cashew, hazelnut and walnut because of a higher range in protein content in comparison with the results from Table 6.

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Abstract

La présente invention concerne une composition destinée à être utilisée dans la prévention, la réduction et/ou le traitement des allergies aux noix et aux graines chez l'être humain. En outre, l'invention concerne des méthodes de prévention, de réduction et/ou de traitement des allergies aux noix et aux graines chez l'être humain. La composition est administrée en une série de 3 à 6 doses, en commençant par une dose initiale, incrémentée par étapes jusqu'à une dose maximale, l'administration pouvant être prolongée par une dose hebdomadaire pendant une durée de 3 à 12 mois.
PCT/NL2023/050534 2022-10-17 2023-10-13 Prévention des allergies aux noix et aux graines chez l'être humain Ceased WO2024085750A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
NL2033338A NL2033338B1 (en) 2022-10-17 2022-10-17 Prevention of tree nut and seed allergy in humans
NL2033338 2022-10-17

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WO2024085750A1 true WO2024085750A1 (fr) 2024-04-25

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2012123759A1 (fr) 2011-03-17 2012-09-20 Cambridge Enterprise Limited Traitement pour l'allergie à l'arachide
WO2017014954A1 (fr) * 2015-07-21 2017-01-26 Assured Bites, Inc. Paquets d'aliment à dosage contrôlé pour la prévention d'une allergie
US20170360922A1 (en) 2016-06-21 2017-12-21 Paul Turke Nutritional supplements and methods for primary prevention of food allergies
WO2020237181A1 (fr) * 2019-05-23 2020-11-26 Aimmune Therapeutics, Inc. Procédés de traitement d'allergie à l'arachide par immunothérapie orale avec entretien à faible dose

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2012123759A1 (fr) 2011-03-17 2012-09-20 Cambridge Enterprise Limited Traitement pour l'allergie à l'arachide
WO2017014954A1 (fr) * 2015-07-21 2017-01-26 Assured Bites, Inc. Paquets d'aliment à dosage contrôlé pour la prévention d'une allergie
US20170360922A1 (en) 2016-06-21 2017-12-21 Paul Turke Nutritional supplements and methods for primary prevention of food allergies
WO2020237181A1 (fr) * 2019-05-23 2020-11-26 Aimmune Therapeutics, Inc. Procédés de traitement d'allergie à l'arachide par immunothérapie orale avec entretien à faible dose

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
BYRNE A M ET AL: "How do we know when peanut and tree nut allergy have resolved, and how do we keep it resolved?", CLINICAL & EXPERIMENTAL ALLERGY, WILEY INTERSCIENCE, UK, vol. 40, no. 9, 20 July 2010 (2010-07-20), pages 1303 - 1311, XP071887186, ISSN: 0954-7894, DOI: 10.1111/J.1365-2222.2010.03554.X *
MIDUN ELISE ET AL: "Recent advances in the management of nut allergy", WORLD ALLERGY ORGANIZATION JOURNAL, vol. 14, no. 1, 1 January 2021 (2021-01-01), London, UK, pages 100491, XP093114155, ISSN: 1939-4551, DOI: 10.1016/j.waojou.2020.100491 *
POOJA VARSHNEY ET AL: "A randomized controlled study of peanut oral immunotherapy: Clinical desensitization and modulation of the allergic response", JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY, ELSEVIER, AMSTERDAM, NL, vol. 127, no. 3, 27 December 2010 (2010-12-27), pages 654 - 660, XP028196576, ISSN: 0091-6749, [retrieved on 20110110], DOI: 10.1016/J.JACI.2010.12.1111 *

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