WO2017009676A4 - Compositions for maintaining and restoring microbiota-host symbiosis - Google Patents

Compositions for maintaining and restoring microbiota-host symbiosis Download PDF

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Publication number
WO2017009676A4
WO2017009676A4 PCT/HU2016/000047 HU2016000047W WO2017009676A4 WO 2017009676 A4 WO2017009676 A4 WO 2017009676A4 HU 2016000047 W HU2016000047 W HU 2016000047W WO 2017009676 A4 WO2017009676 A4 WO 2017009676A4
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diseases
combination
polysaccharide
bacteria
micronized
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PCT/HU2016/000047
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French (fr)
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WO2017009676A1 (en
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János FEHÉR
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Fehér János
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    • C12N1/00—Microorganisms, e.g. protozoa; Compositions thereof; Processes of propagating, maintaining or preserving microorganisms or compositions thereof; Processes of preparing or isolating a composition containing a microorganism; Culture media therefor
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    • A61K31/7105—Natural ribonucleic acids, i.e. containing only riboses attached to adenine, guanine, cytosine or uracil and having 3'-5' phosphodiester links
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Abstract

This invention is related to compositions containing combinations of microbial lysates and micronized polysaccharides and use thereof for maintaining and restoring microbiota-host symbiosis in humans or animals or plants.

Claims

AMENDED CLAIMS received by the International Bureau on 16 February 2017 (16.02.2017)
Claim 1. A composition for maintaining and restoring a symbiosis between microbio- ta-hosts in humans, animals or plants, whereby said composition contains a combination of
(i) at least one microbial lysate where said microbial lysate is a killed and fragmented microbe containing deoxyribonucleic acid/ribonucleic acid and/or lipopolysaccha- ride/peptidoglycan derived from at least one species of bacteria and/or archaea, and/or yeasts and/or viruses residing in the human microbiota, the animal microbiota or the plant microbiota, or from their combinations, or derived from their synthetic or semisynthetic analogs;
where the at least one species of bacteria is selected from the group of Lactobacillus acidophilus, Lactobacillus casei, Bifidobacterium animalis, Sacharomyces cerevisiae, Lactobacillus rhamnosus, Bifidobacterium longum, Lactobacillus plantarum, Escherichia coli, Clostridium perfringens, Pseudomonas putida , Helicobacter pylori, Porphirinomas gingivalis, Listeria monocytogenes, Staphylococcus thermophiles,
Agrobacterium vitis, Xanthomonas citri, Bifidobacterium bifidum, Lactobacillus reuteri or any combination thereof,
and the solid content of said microbial lysate having a particle size from 0,001 to 5,0 micron; and
(ii) at least one micronized polysaccharide compatible for human and/or animal nutrition and/or fertilization of plants, derived from natural sources comprising at least one species of bacteria, algae, mushrooms, plants, or any combination thereof, or from their synthetic or semisynthetic analogs; and said micronized polysaccharide having a particle size from 0,1 micron to 5 micron or a fibril length of 0,1 micron to 10 mm, and where the natural source is selected from the group of Cordyceps pruinosa, Cor- iolus versicolor, Agaricus blazei Murill, rose petals from Rosa centiflora, aloe vera, algae, tart cherry, smoke tree, Jerusalem artichoke or chicory, or any combination thereof;
while
the ratio of the microbial lysate to the polysaccharide has to be higher for the polysaccharide as measured by their dry-weight content.
Claim 2. The composition according to Claim 1 wherein
(i) the microbial lysate is derived from beneficial and/or saprophyte-commensal and/or pathogenic microorganism, or from any combination thereof, regardless from biological characteristics of not-lysed microbes, and
(ii) the micronized polysaccharide is derived from polysaccharides digesti- ble/absorbable and/or non-digestible/non-absorbable for humans and/or animals, from polysaccharides degradable/absorbable and/or non-degradable/non-absorbable for host plants, regardless from biological characteristics of natural, non-micronized forms of polysaccharides.
Claim 3. The composition according to any of Claims 1 and 2, containing at least one pharmacologically compatible additive ingredient selected from the group of omega-3 fatty acids in natural form such as fish oil, cod liver oil, vegetable oil or any combination thereof; sources of alpha-linolenic acid, eicosapehtaenoic acid or do- cosahexaenoic acid or any ester thereof; triglyceride; phospholipids, preferably phosphatidyl-inositol, phosphatidyl-choline, phosphatidyl-ethanolamine, phosphatidyl-serine and sphingomyelin, or any combination thereof; omega-3 fatty acids in form of one of its precursors derived from fish-oil, plant-oil, or any combination thereof; vitamin A, B, C, D, E, F, K and ubiquinone; hormones, such as corticosteroids and sex-steroid; metal ions; L-carnitine, aminocarnitines, alpha-lipoic acid, glutathion, amino acids, bioflavonoids, polyphenols, curcumin, terpenes, alkaloides, volatile oils, antibiotics, glycosaminoglycans; or any combination thereof.
Claim 4. The composition according to any of Claims 1 to 3, containing at least one formulation ingredient selected from the group of water, glycerin, beeswax, sorbitol, lecithin, anti-aggregates, emulgens, buffers, preservatives, or any combination thereof; for improving delivery and increasing bioavailability.
Claim 5. The composition according to any of Claims 1 to 4; for human and animal use in
(i) enteral application such as oral, intra-gastric, trans-nasal, rectal application;
(ii) parenteral application such as intravenous, intraocular, intramuscular, intradermal, intraarticular, intralesional, paralesional, subcutaneous application;
(iii) topical application in form of eye-drops, ear-drops, gel, soft-gel, spray, ointment, lotion;
(iv) liposome encapsulated delivery
Claim 6. The composition according to any of Claims 1 to 5 for use in the prevention and treatment of:
(i) bacterial, viral, fungal and parasitic infections;
(ii) ischemia-reperfusion, selected from acute cerebral ischemia, chronic cerebral ischemia, stroke;
(iii) mucous membrane diseases selected from the group of conjunctivitis, otitis, peri- odontitis, caries, oesophagitis, reflux disease, gastritis, enteritis, colitis, cholecystitis, cystitis, pyelo-nephritis, sinusitis, bronchitis, vaginitis, prostatitis; or selected from the group of hepatitis, cirrhosis, nephritis, pleuritis, fibrosis cystica;
(iv) autoimmune diseases, selected from rheumatoid arthritis, juvenile or type I diabetes, Crohn's disease, ulcerous colitis, psoriasis, lupus erythematous, multiple Scle- rosis;
(v) neuropsychiatric diseases, selected from schizophrenia, depression, anxiety, panic-disease; (vi) allergenic diseases selected from bronchial asthma, atopic dermatitis, hay-fever, allergic conjunctivitis, allergic rhinitis;
(vii) metabolic diseases and syndrome, which comprises dyslipidemia, atherosclerosis, arterial hypertension, type 2 diabetes, obesity, fatty liver;
(viii) proliferative neovascular and neoplastic diseases, wherein the neovascular disease is proliferative retinopathy, retinopathy of prematurity, malignant tumors;
(ix) age-related degenerative diseases, selected from Alzheimer's disease, Parkinson's disease, amyotropic lateral sclerosis, otosclerosis, osteoporosis, osteoarthritis, sarcopenia, hairlessness, age-related skin changes;
(x) soft tissue damages, selected from postoperative inflammation, sport injuries, extreme sport activities, contusions, burnings, cancer, lung cancer, colon cancer, lymphomas, and chemotherapy associated inflammations;
(xi) eye diseases, selected from uveitis, diabetic retinopathy, age-related macular degeneration, glaucoma, cataract;
(xii) arterial hypertension and atherosclerosis-related diseases, selected from coronary heart disease, cardiac arrhythmia, chronic heart failure, nephrosis syndrome, peripheral vascular diseases;
(xiii) skin diseases, selected from sensitive or irritable skin, cellulitis; Claim 7. The composition according to any of Claims 1 to 6, for use in
(i) special medical conditions, selected from gene-transfer using natural, semisynthetic or synthetic deoxyribonucleic acid or ribonucleic acid; supporting survival of transplanted stem cells and organs; culturing medium for cell-culture, tissue-culture and bacterial-culture; feeding infants; feeding critically ill and convalescent persons, substituting fecal transplantation, or any combination thereof;
(ii) animal nutrition; or
(iii) plant nutrition, plant fertilization.

STATEMENT UNDER ARTICLE 19(1) (Rule 46.4) revised claims 1-7 fulfil the condition for inventive step follows :

The particle size of micronized microbial lysate and mi- cronized polysaccharide is critical for their biological effects. Both of these substances are molecular ligands for specific receptors of host cells (epithelium, immune cells, nerve cells) . Thus, neither smaller nor higher particle size can bind to receptors for steric reasons. We claim a narrow range of particle size to reach optimal benefits. In diseases the digestion of these substances is incomplete, thus their biological effect is poor due to the inappropriate particle size. Our invention circumvents this drawback by the use of specific particle size. This was not evident from prior arts even for skilled persons.

Dl document describes a vaccine with polysaccharide adjuvant to bird influenza virus. First, bird influenza virus is not a member of normal human or animal microbiota. Second, vaccines are used to enhance adaptive immunity of humans, animals and plants against the same microorganism (specific effect) . Our claims are related to enhance innate immunity of humans, animals and plants through maintaining or restoring symbiosis (non-specific effect). There is no indication of micronizing.

D2 document presents a commercialized product containing "ultra-micronized polysaccharide" using Lactobacillus acidophilus and several vitamins, minerals, trace elements. From the formulation of the product it is evident, that it contains probiotic bacteria, which is a live bacterium. Our claims are related to killed bacteria. Furthermore, our claims are not restricted to the use of a probiotic subgroup of bacteria (as lysate of any bacteria containing genomic CpG oligodeoxynucleotide may be useful in a given case) .

D3 document describes compositions containing probiotic lysate together with omega 3 fatty acids and/or vitamins. It does not mention our second component (i.e. micronized polysaccharide) at all.

D4 document discloses a method of increasing the numbers of live bacteria on the skin (and virtually on other sites of the symbiosis) . This document is not relevant to our claims 1-7, which disclose a composition for maintaining and restoring the symbiosis between micriobiota-hosts, whereby composition comprises microbial lysate (i.e. killed and fragmented microbae) .

PCT/HU2016/000047 2015-07-16 2016-07-15 Compositions for maintaining and restoring microbiota-host symbiosis WO2017009676A1 (en)

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FR3045383B1 (en) 2015-12-18 2019-06-14 Maat Pharma PROCESS FOR THE FREEZING OF A FECAL MICROBIOTE SAMPLE
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CN110954605B (en) * 2019-10-08 2021-04-30 华中科技大学同济医学院附属协和医院 Pleural effusion microparticle metabolite combination, kit and method for diagnosing tuberculous pleurisy
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