WO2017106036A1 - Enzyme formulation for reducing salicylate and other intolerance - Google Patents

Enzyme formulation for reducing salicylate and other intolerance Download PDF

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Publication number
WO2017106036A1
WO2017106036A1 PCT/US2016/065813 US2016065813W WO2017106036A1 WO 2017106036 A1 WO2017106036 A1 WO 2017106036A1 US 2016065813 W US2016065813 W US 2016065813W WO 2017106036 A1 WO2017106036 A1 WO 2017106036A1
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Prior art keywords
formulation
chymotrypsin
lactase
phytase
invertase
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PCT/US2016/065813
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French (fr)
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Thea FOURNIER
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Individual
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Individual
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Priority to CA3007374A priority Critical patent/CA3007374A1/en
Priority to EP16876422.3A priority patent/EP3390647A4/en
Publication of WO2017106036A1 publication Critical patent/WO2017106036A1/en
Anticipated expiration legal-status Critical
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46Hydrolases (3)
    • A61K38/48Hydrolases (3) acting on peptide bonds (3.4)
    • A61K38/482Serine endopeptidases (3.4.21)
    • A61K38/4826Trypsin (3.4.21.4) Chymotrypsin (3.4.21.1)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46Hydrolases (3)
    • A61K38/465Hydrolases (3) acting on ester bonds (3.1), e.g. lipases, ribonucleases
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46Hydrolases (3)
    • A61K38/47Hydrolases (3) acting on glycosyl compounds (3.2), e.g. cellulases, lactases
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46Hydrolases (3)
    • A61K38/48Hydrolases (3) acting on peptide bonds (3.4)
    • A61K38/482Serine endopeptidases (3.4.21)
    • A61K38/4866Protein C (3.4.21.69)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/14Prodigestives, e.g. acids, enzymes, appetite stimulants, antidyspeptics, tonics, antiflatulents
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12YENZYMES
    • C12Y301/00Hydrolases acting on ester bonds (3.1)
    • C12Y301/03Phosphoric monoester hydrolases (3.1.3)
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12YENZYMES
    • C12Y302/00Hydrolases acting on glycosyl compounds, i.e. glycosylases (3.2)
    • C12Y302/01Glycosidases, i.e. enzymes hydrolysing O- and S-glycosyl compounds (3.2.1)
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12YENZYMES
    • C12Y302/00Hydrolases acting on glycosyl compounds, i.e. glycosylases (3.2)
    • C12Y302/01Glycosidases, i.e. enzymes hydrolysing O- and S-glycosyl compounds (3.2.1)
    • C12Y302/01026Beta-fructofuranosidase (3.2.1.26), i.e. invertase
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12YENZYMES
    • C12Y302/00Hydrolases acting on glycosyl compounds, i.e. glycosylases (3.2)
    • C12Y302/01Glycosidases, i.e. enzymes hydrolysing O- and S-glycosyl compounds (3.2.1)
    • C12Y302/01108Lactase (3.2.1.108)
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12YENZYMES
    • C12Y304/00Hydrolases acting on peptide bonds, i.e. peptidases (3.4)
    • C12Y304/21Serine endopeptidases (3.4.21)
    • C12Y304/21001Chymotrypsin (3.4.21.1)

Definitions

  • Salicylates are compounds that are manufactured synthetically and found in artificial colorings and flavorings, solvents, many personal care products and elsewhere in some foods as additives/preservatives. These salicylate compounds are also naturally occurring in many plant foods, including fruits, vegetables, and herbs/spices. In the course of many years of consulting and observing thousands of clients, the inventor has found that patients who follow the recommended dietary restrictions (which reduce or substantially eliminate salicylates), experience a significant improvement in a wide range of symptoms and pathologies.
  • Eliminating salicylates and adhering to the recommendations appears to be highly effective in treating a wide range of symptoms/conditions, including, but not limited to: stuttering, migraines, ADHD, behavioral deficits, Tourettes disease, seizures, autism (ASD), atrial fibrillation., anxiety, depression, joint pain, cognitive and perceptual disorders, respiratory difficulties and non-diabetic neuropathy.
  • Beta Glucanase has been found to be effective in treating salicylate intolerant people, and causing a significant improvement in a wide variety of symptoms/conditions, including, but not limited to: stuttering, migraines, ADHD, behavioral deficits, Tourettes disease, seizures, autism (ASD)., atrial fibrillation., anxiety, depression, joint pain, cognitive and perceptual disorders, respiratory difficulties and non-diabetic neuropathy. It may also be used to treat intolerance of gluten, corn or soy. It is believed that the formulation catalyzes breakdown of salicylate compounds in vivo.
  • the preferred dosages of the enzymes in the formulation are as follows: Beta Glucanase: 200 BGU; Chymotrypsin (from porcine, preferably, or beef) 3.0 mg (or not less than 3000 USP units), or at least about 6.0 mg; Phytase 30 FTU; Lactase 600 ALU, and Invertase 600 INVU. More preferred, is ingesting two or more of the formulation with the foregoing contents with each meal.
  • a preferred carrier for the formulation is a vegetable capsule (including, mostly cellulose and distilled water). Most preferred is that the formulation be free of any of the following: casein, gluten, dairy, egg, soy, corn, peanuts, tree nuts, and fish.
  • Group/branch one After baseline symptom information has been collected, patients in group one will remove salicylates 100% from their daily diet for two months. After the two months , they will fill out the form again checking symptoms they are experiencing and severity of them. The Formulation will then be administered to each patient who has experienced significant improvement in those symptoms/conditions. After three weeks on the formulation, patients will begin consuming salicylate containing food. Their symptoms will be monitored bi-weekly for two months. As a result of being on the Formulation, it will be determined if they can successfully eat salicylates without a recurrence of adverse symptoms, if there is increased improvement, or if symptoms worsen.
  • the preferred dosages of the enzymes set forth in the Summary are not the only dosages possible, and other more optimal dosages and dosing regimes may be discovered with routine experimentation, now that the preferred dosages are known.
  • the routine experimentation would involve providing different dosages under different regimes, using behavioral kinesiology to determine the appropriate dosage and optimal regime for each individual child or adult in the case study, and determining which patients improved most in their monitored diseases and conditions.
  • the starting point for determining optimal dosing and an optimal regime is the preferred dosages, administered once a day, as above. Variations could be doubling, halving, or otherwise and reducing the quantities of one or more of the enzymes in a formulation.
  • the dosing regime modifications could include increasing or reducing the number of administrations of the formulation each day for patients in a particular group. Such experimentation is routine in the pharmaceutical industry.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Immunology (AREA)
  • Epidemiology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Nutrition Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)

Abstract

Disclosed is a formulation of the following enzymes: Beta Glucanase, Chymotrypsin, Phytase, Lactase, and Invertase, which has been found to be effective in treating salicylate intolerant people, and causing a significant improvement in a wide variety of pathologies and symptoms, including, but not limited to: stuttering, migraines, ADHD, behavioral deficits, Tourettes disease, seizures, autism (ASD), atrial fibrillation., anxiety, depression, joint pain, cognitive and perceptual disorders, respiratory difficulties and non-diabetic neuropathy. The formulation is also for treating or reducing intolerance of gluten, corn or soy.

Description

Enzyme Formulation for Reducing Salicylate and Other Intolerance Background
Many people suffer from food intolerance. It is believed that many such people' s intolerances can be traced to use of pesticides, and/or genetically engineered foods, which adversely affect liver pathways, inhibit enzymes, and disrupt amino acids in the body which ultimately can lead to food intolerances.
Intolerance to gluten has been widely discussed. Less well known, but equally widespread, is intolerance to salicylates and histamines. Salicylates are compounds that are manufactured synthetically and found in artificial colorings and flavorings, solvents, many personal care products and elsewhere in some foods as additives/preservatives. These salicylate compounds are also naturally occurring in many plant foods, including fruits, vegetables, and herbs/spices. In the course of many years of consulting and observing thousands of clients, the inventor has found that patients who follow the recommended dietary restrictions (which reduce or substantially eliminate salicylates), experience a significant improvement in a wide range of symptoms and pathologies. Eliminating salicylates and adhering to the recommendations, appears to be highly effective in treating a wide range of symptoms/conditions, including, but not limited to: stuttering, migraines, ADHD, behavioral deficits, Tourettes disease, seizures, autism (ASD), atrial fibrillation., anxiety, depression, joint pain, cognitive and perceptual disorders, respiratory difficulties and non-diabetic neuropathy.
Summary
A formulation of the following enzymes: Beta Glucanase, Chymotrypsin, Phytase, Lactase, and Invertase, has been found to be effective in treating salicylate intolerant people, and causing a significant improvement in a wide variety of symptoms/conditions, including, but not limited to: stuttering, migraines, ADHD, behavioral deficits, Tourettes disease, seizures, autism (ASD)., atrial fibrillation., anxiety, depression, joint pain, cognitive and perceptual disorders, respiratory difficulties and non-diabetic neuropathy. It may also be used to treat intolerance of gluten, corn or soy. It is believed that the formulation catalyzes breakdown of salicylate compounds in vivo. More particularly, the preferred dosages of the enzymes in the formulation are as follows: Beta Glucanase: 200 BGU; Chymotrypsin (from porcine, preferably, or beef) 3.0 mg (or not less than 3000 USP units), or at least about 6.0 mg; Phytase 30 FTU; Lactase 600 ALU, and Invertase 600 INVU. More preferred, is ingesting two or more of the formulation with the foregoing contents with each meal. A preferred carrier for the formulation is a vegetable capsule (including, mostly cellulose and distilled water). Most preferred is that the formulation be free of any of the following: casein, gluten, dairy, egg, soy, corn, peanuts, tree nuts, and fish.
A discussion of testing and demonstrating the safety and efficacy of the formulation is set forth below in the Detailed Description.
Detailed Description
It has been found over decades of study, that people who adopt a dietary restriction plan which eliminates foods and food products containing salicylates experience significant improvement in some, but not limited to, the following symptoms and conditions: stuttering, migraines, ADHD, behavioral deficits, Tourettes disease, seizures, autism (ASD)., atrial fibrillation., anxiety, depression, joint pain, cognitive and perceptual disorders, respiratory difficulties and non-diabetic neuropathy. The formulation will be administered to two groups of patients in order to test its treatment effects.
Group/branch one: After baseline symptom information has been collected, patients in group one will remove salicylates 100% from their daily diet for two months. After the two months , they will fill out the form again checking symptoms they are experiencing and severity of them. The Formulation will then be administered to each patient who has experienced significant improvement in those symptoms/conditions. After three weeks on the formulation, patients will begin consuming salicylate containing food. Their symptoms will be monitored bi-weekly for two months. As a result of being on the Formulation, it will be determined if they can successfully eat salicylates without a recurrence of adverse symptoms, if there is increased improvement, or if symptoms worsen.
Group/branch two: Salicylate intolerant patients in group two will remove no salicylates from their daily diet. Eligible patients will be randomly assigned to receive the Formulation (n=25) or Placebo (n=25) after eligibility is established and baseline symptoms and severity of symptoms have been assessed. Over a two month period of follow-up, patients symptoms and conditions will be monitored at monthly visits. All primary analyses will be based on the intention-to-treat principle. Formulation and placebo groups will be compared and proof of efficacy would be a statistically significant improvement in one or more of the foregoing of symptoms or conditions. Statistically significant differences at the alpha 0.05 level will be reported.
The preferred dosages of the enzymes set forth in the Summary are not the only dosages possible, and other more optimal dosages and dosing regimes may be discovered with routine experimentation, now that the preferred dosages are known. The routine experimentation would involve providing different dosages under different regimes, using behavioral kinesiology to determine the appropriate dosage and optimal regime for each individual child or adult in the case study, and determining which patients improved most in their monitored diseases and conditions.
The starting point for determining optimal dosing and an optimal regime, is the preferred dosages, administered once a day, as above. Variations could be doubling, halving, or otherwise and reducing the quantities of one or more of the enzymes in a formulation. The dosing regime modifications could include increasing or reducing the number of administrations of the formulation each day for patients in a particular group. Such experimentation is routine in the pharmaceutical industry.
The terms and expressions that have been employed are used as terms of description and not of limitation, and there is no intent in the use of such terms and expressions to exclude any equivalent of the features shown and described or portions thereof, but it is recognized that various modifications are possible within the scope of the invention as claimed. Thus, it will be understood that although the present invention has been specifically disclosed by preferred embodiments and optional features, modification and variation of the concepts herein disclosed may be resorted to by those skilled in the art, and that such modifications and variations are considered to be within the scope of this invention as defined by the appended claims.

Claims

What Is Claimed Is:
1. A formulation for eliminating symptoms of one or more of the following diseases or conditions: stuttering, migraines, ADHD, behavioral deficits, Tourettes disease, seizures, autism (ASD)., atrial fibrillation., anxiety, depression, joint pain, cognitive and perceptual disorders, respiratory difficulties and non-diabetic neuropathy, comprising the enzymes: Beta Glucanase, Chymotrypsin, Phytase, Lactase and Invertase.
2. A formulation for treating or reducing intolerance of gluten, corn or soy comprising the enzymes: Beta Glucanase, Chymotrypsin, Phytase, Lactase and Invertase.
3. The formulation of claim 1, wherein the quantities of the enzymes in the formulation are: Beta Glucanase, 200 BGU; Chymotrypsin, not less than 3000 USP units; Phytase 30 FTU; Lactase 600 ALU and Invertase 600 INVU.
4. The formulation of claim 2, wherein the quantities of the enzymes in the formulation are: Beta Glucanase, 200 BGU; Chymotrypsin, not less than 3000 USP units; Phytase 30 FTU; Lactase 600 ALU and Invertase 600 INVU.
5. The formulation of claim 1 wherein the Chymotrypsin is derived from porcine, preferably, or beef and the quantity is 3.0 mg.
6. The formulation of claim 2 wherein the Chymotrypsin is derived from porcine, preferably, or beef and the quantity is 3.0 mg.
7. A method for clearing up symptoms of one or more of the following diseases or conditions: stuttering, migraines, ADHD, behavioral deficits, Tourettes disease, seizures, autism (ASD)., atrial fibrillation., anxiety, depression, joint pain, cognitive and perceptual disorders, respiratory difficulties and non-diabetic neuropathy, comprising administering a formulation including the enzymes: Beta Glucanase, Chymotrypsin, Phytase, Lactase and Invertase.
8. The method of claim 7 wherein the quantities of the enzymes in the formulation are: Beta Glucanase, 200 BGU; Chymotrypsin, not less than 3000 USP units; Phytase 30 FTU; Lactase 600 ALU and Invertase 600 INVU, and the formulation is administered twice per day.
9. The method of claim 7 wherein the Chymotrypsin is derived from porcine, preferably, or beef, and the quantity is 3.0 mg.
PCT/US2016/065813 2015-12-14 2016-12-09 Enzyme formulation for reducing salicylate and other intolerance Ceased WO2017106036A1 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
CA3007374A CA3007374A1 (en) 2015-12-14 2016-12-09 Enzyme formulation for reducing salicylate and other intolerance
EP16876422.3A EP3390647A4 (en) 2015-12-14 2016-12-09 ENZYMATIC FORMULATION TO REDUCE SALICYLATE INTOLERANCE AND OTHER INTOLERANCES

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US14/967,746 US9775887B2 (en) 2015-12-14 2015-12-14 Enzyme formulation for reducing salicylate intolerance
US14/967,746 2015-12-14

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Publication number Priority date Publication date Assignee Title
US10195256B2 (en) * 2015-12-14 2019-02-05 Thea Fournier Enzyme formulation for reducing salicylate and other intolerance

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20060115467A1 (en) * 2004-12-01 2006-06-01 Pangborn Jon B Compositions and methods for the treatment of autism
US20070116695A1 (en) * 2005-09-21 2007-05-24 Fallon Joan M Pharmaceutical preparations for attention deficit disorder, attention deficit hyperactivity disorder and other associated disorders
US20100260857A1 (en) * 2009-04-13 2010-10-14 Joan Fallon Enzyme delivery systems and methods of preparation and use
US20170000830A1 (en) * 2015-07-01 2017-01-05 Rakesh Saini Compositions for Relieving the Symptoms of Gluten Sensitivity and Methods of Use Thereof

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080199448A1 (en) * 2007-02-16 2008-08-21 Ross Mairi R Enzyme composition for improving food digestion

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20060115467A1 (en) * 2004-12-01 2006-06-01 Pangborn Jon B Compositions and methods for the treatment of autism
US20070116695A1 (en) * 2005-09-21 2007-05-24 Fallon Joan M Pharmaceutical preparations for attention deficit disorder, attention deficit hyperactivity disorder and other associated disorders
US20100260857A1 (en) * 2009-04-13 2010-10-14 Joan Fallon Enzyme delivery systems and methods of preparation and use
US20170000830A1 (en) * 2015-07-01 2017-01-05 Rakesh Saini Compositions for Relieving the Symptoms of Gluten Sensitivity and Methods of Use Thereof

Non-Patent Citations (2)

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Title
ANONYMOUS: "VITAL-ZYMES COMPLETE. Supplement Facts", VITAL-ZYMES COMPLETE., 2007, pages 10-11, 17 - 18, XP009519654 *
See also references of EP3390647A4 *

Also Published As

Publication number Publication date
EP3390647A1 (en) 2018-10-24
US9775887B2 (en) 2017-10-03
EP3390647A4 (en) 2019-08-21
US20170165329A1 (en) 2017-06-15
CA3007374A1 (en) 2017-06-22

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