COMPOSITION FOR USE IN A METHOD FOR PREVENTION OR TREATMENT OF MALTNUTRITION IN A SUBJECT SUFFERING FROM A CHRONIC INFLAMMATORY BOWEL DISEASES

Abstract

A mixture (M) comprising or, alternatively consisting of: (i) water-soluble oligosaccharide, or a water-soluble complex carbohydrate, or mixtures thereof; (II) a casein; (ill) n3 and/or n6 fatty acids; (iv) an extract of Vaccinium macrocarpon. The present invention further relates to a pharmaceutical composition, or a food for special medical purpose (FSMP), or a medical device formulation or composition, or a dietary supplement comprising the aforementioned mixture (M), for use as medicament, or for use in the treatment of a chronic inflammatory bowel disease, in particular of states of malnutrition in subjects suffering from said chronic inflammatory bowel disease.

Claims

1. A mixture (M) for use in a method for preventive and/or curative treatment of a state of malnutrition in a subject suffering from a chronic inflammatory bowel disease, wherein said mixture (M) comprises or, alternatively, consists of: (i) a water-soluble saccharide selected from among a water-soluble oligosaccharide, a water-soluble complex carbohydrate, or mixtures thereof; (ii) a casein; (iii) a linseed oil as source of n3 and/or n6 fatty acids, wherein said linseed oil comprises a α-linolenic acid and a linoleic acid, wherein the α-linolenic acid is comprised in the linseed oil at a % by weight comprised in the range from 20% to 80%, with respect to the total weight of linseed oil; and (iv) an extract of Vaccinium macrocarpon fruits; and wherein the mixture (M) comprises: (i) the water-soluble saccharide at an amount comprised in the range from 35% to 60% by weight; (ii) the casein at an amount comprised in the range from 10% to 30% by weight; (iii) the n3 and/or n6 fatty acids at an amount comprised in the range from 3% to 20% by weight; (iv) the extract of Vaccinium macrocarpon fruits at an amount comprised in the range from 0.01% to 5% by weight, the extract (iv) being titrated in proanthocyanidins at a % by weight comprised from 10% to 60% by weight; wherein said % are expressed with respect to the total weight of the mixture (M).

2. The mixture (M) for use according to claim 1, wherein said chronic inflammatory bowel disease is selected from among: Crohn's disease, ulcerative colitis, microscopic colitis, collagenous colitis and lymphocytic colitis, eosinophilic esophagitis, and indeterminate colitis, ischemic colitis, diversion colitis, Behçet's disease, pouchitis, ileitis and colitis.

3. The mixture (M) according to claim 1, wherein the water soluble saccharide (i): casein (ii) by weight ratio is comprised from 4:1 to 1:4, preferably from 3:1 to 1:3, more preferably from 2:1 to 1:2.

4. The mixture (M) according to claim 1, comprising: (i) the water-soluble saccharide at an amount comprised in the range from 40% to 58% by weight, preferably from 45% to 55% by weight; (ii) the casein, preferably micellar casein, at an amount comprised in the range from 15% to 28% by weight, preferably from 20% to 26% by weight; (iii) the n3 and/or n6 fatty acids at an amount comprised in the range from 5% to 16% by weight, preferably from 7% to 14% by weight; (iv) the extract of Vaccinium macrocarpon fruits at an amount comprised in the range from 0.05% to 3% by weight, preferably from 0.1% to 1% by weight; the extract (iv) being titrated in proanthocyanidins at a percentage by weight comprised in the range from 30% to 50% by weight, preferably from 35% to 45% by weight; wherein said % are expressed with respect to the total weight of the mixture (M).

5. The mixture (M) according to claim 1, wherein the water-soluble oligosaccharide is a maltodextrin, and/or wherein the water-soluble complex carbohydrate is selected from among the group comprising or, alternatively, consisting of inulin, starch and mixtures thereof.

6. The mixture (M) according to claim 1, wherein the percentage by weight of α-linolenic acid in the linseed oil is comprised in the range from 30% to 70% by weight, preferably from 40% to 60% by weight, with respect to the total weight of the linseed oil.

7. The mixture (M) according to the claim 6, wherein the linseed oil: casein (ii) by weight ratio is comprised from 3:1 to 1:3, preferably from 1.5:1 and 1:1.5, more preferably of about 1:1.

8. A method for preventive and/or curative treatment of a state of malnutrition in a subject suffering from a chronic inflammatory bowel disease, comprising administering to the subject a composition comprising mixture (M) comprising: (i) a water-soluble saccharide selected from among a water-soluble oligosaccharide, a water-soluble complex carbohydrate, or mixtures thereof; (ii) a casein; (iii) a linseed oil as source of n3 and/or n6 fatty acids, wherein said linseed oil comprises a α-linolenic acid and a linoleic acid, wherein the α-linolenic acid is comprised in the linseed oil at a % by weight comprised in the range from 20% to 80%, with respect to the total weight of linseed oil; and (iv) an extract of Vaccinium macrocarpon fruits; wherein (i) the water-soluble saccharide is at an amount comprised in the range from 35% to 60% by weight; (ii) the casein is at an amount comprised in the range from 10% to 30% by weight; (iii) the n3 and/or n6 fatty acids is at an amount comprised in the range from 3% to 20% by weight; (iv) the extract of Vaccinium macrocarpon fruits is at an amount comprised in the range from 0.01% to 5% by weight, the extract (iv) being titrated in proanthocyanidins at a % by weight comprised from 10% to 60% by weight; wherein said % are expressed with respect to the total weight of the mixture (M).

9. The method of claim 8, wherein said patient is suffering from a chronic inflammatory bowel disease selected from among Crohn's disease, ulcerative colitis, microscopic colitis, eosinophilic esophagitis, and indeterminate colitis.

10. The method of claim 8, wherein said composition further comprises (b) one or more mineral salts, wherein the mineral salt is selected from among the group comprising or, alternatively, consisting of: potassium, calcium, magnesium, iron, copper, zinc, manganese, iodine, molybdenum, selenium, chromium, chlorine, sodium and combinations thereof.

11. The method of claim 8, wherein said composition further comprises (d) one or more vitamin substances, wherein the vitamin substance is selected from among the group comprising or, alternatively, consisting of: vitamin A, vitamin D3, vitamin E, vitamin C, vitamin K2, vitamin B1, vitamin B2, vitamin B3, vitamin B6, folic acid, vitamin B12, vitamin H, vitamin B5, vitamin J, vitamin B7, and combinations thereof.

12. The method of claim 8, in association with at least one isolated strain of bacteria, preferably bacteria with probiotic function, more preferably lactic ferments, and/or bacterial lysates, tyndallized bacteria, inactivated bacteria (paraprobiotics), postbiotics, or combinations thereof.

13. The method of claim 8, wherein said composition is a pharmaceutical composition, or a food for special medical purpose (FSMP), or a medical device formulation or composition, or a dietary supplement.

14. The method of claim 8, wherein the water soluble saccharide (i): casein (ii) by weight ratio is in the range of 4:1 to 1:4.

15. The method of claim 8, wherein (i) the water-soluble saccharide is at an amount comprised in the range from 40% to 58% by weight, preferably from 45% to 55% by weight; (ii) the casein, preferably micellar casein, is at an amount comprised in the range from 15% to 28% by weight, preferably from 20% to 26% by weight; (iii) the n3 and/or n6 fatty acids are at an amount comprised in the range from 5% to 16% by weight, preferably from 7% to 14% by weight; (iv) the extract of Vaccinium macrocarpon fruits is at an amount comprised in the range from 0.05% to 3% by weight, preferably from 0.1% to 1% by weight; the extract (iv) being titrated in proanthocyanidins at a percentage by weight comprised in the range from 30% to 50% by weight, preferably from 35% to 45% by weight; wherein said % are expressed with respect to the total weight of the mixture (M).

16. The method of claim 8, wherein the water-soluble oligosaccharide is a maltodextrin, and/or wherein the water-soluble complex carbohydrate is selected from among the group comprising or, alternatively, consisting of inulin, starch and mixtures thereof.

17. The method of claim 8, wherein the percentage by weight of α-linolenic acid in the linseed oil is comprised in the range from 30% to 70% by weight, with respect to the total weight of the linseed oil.

18. The method of claim 8, wherein the linseed oil: casein (ii) by weight ratio is comprised from 3:1 to 1:3.

Description

EXAMPLES

Example 1: Qualitative and Quantitative Composition of the Present Composition

[0174] Table 1 below illustrates an embodiment of the present composition (c).

TABLE-US-00001 TABLE 1 Component Weight in mg. Maltodextrins (CAS N° 9050-36-6) 13844.769 micellar casein (sunflower lecithin) 6875.000 Linseed oil (Linum usitatissimum L., silicon dioxide) 6666.667 potassium citrate (CAS N° 866-84-2) 430.556 calcium phosphate (CAS No° 7758-87-4) 368.966 magnesium citrate (CAS N° 7779-25-1) 262.500 flavour (for example vanilla) 250.00 choline bitartrate (CAS N° 87-67-2) 83.750 sodium chloride (CAS N° 7647-14-5) 82.562 sweetener: sucralose (CAS N° 56038-13-2) 45.00 extract of Vaccinium macrocarpon L fruit titrated to 36.250 40% proanthocyanidins L-ascorbic acid (CAS N° 50-81-7) 18.500 iron pyrophosphate (CAS N° 10058-44-3) 11.765 DL-alpha-tocopheryl acetate (CAS N° 7695-91-2) 7.778 zinc citrate (CAS N° 546-46-3) 4.968 phytomenadione (glucose syrup, gum arabic, 2.500 phytomenadione, tricalcium phosphate) Inositol (CAS N° 6917-35-7) 2.400 Nicotinamide (CAS N° 98-92-0) 2.250 manganese gluconate (CAS N° 6485-39-8) 0.957 retinyl acetate (CAS N° 127-47-9) 0.517 calcium d-pantothenate (CAS N° 137-08-6) 0.488 copper sulphate (CAS No° 7758-98-7) 0.431 Cholecalciferol (sucrose, gum arabic, corn starch, 0.350 medium chain triglycerides, tricalcium phosphate, cholecalciferol, DL-alpha-tocopherol) pyridoxine hydrochloride (CAS N° 58-56-0) 0.207 thiamine hydrochloride (CAS N° 67-03-8) 0.148 Riboflavin (CAS N° 83-88-5) 0.115 pteroylmonoglutamic acid (CAS N° 59-30-3) 0.039 Chromium picolinate (CAS N° 14639-25-9) 0.038 sodium selenite (CAS N° 10102-18-8) 0.021 potassium iodide (CAS N° 7681-11-0) 0.012 sodium molybdate (CAS N° 10102-40-6) 0.010 D-biotin (CAS N° 58-85-5) 0.005 Cyanocobalamin (CAS N° 68-19-9) 0.000234 Total weight: 29000.00

[0175] A potassium citrate, preferably anhydrous, usable in the present composition (c) is preferably a powder with a loss on drying at (180° C. for four hours) comprised from 0.5% to 2.0%.

[0176] The calcium phosphate is preferably anhydrous and in powder form. More preferably, such powder has a loss on ignition at 800° C. comprised from 7.0% to 8.5%, and a loss on drying (at 150° C. for two hours) comprised from 1.0% to 3.0%. Even more preferably, a solution in water containing 20% by weight of such powder has a pH value comprised from 4.5 to 6.0.

[0177] A magnesium citrate, preferably dibasic, usable in the present composition (c) is a water-soluble fine powder, in which an aqueous solution at 5% by weight of such powder has a pH value comprised from 3.7 to 4.0. Preferably, such powder could contain heavy metals at a total amount comprised from 0.1 ppm to 5 ppm (for example lead from 0.1 ppm to 3 ppm, cadmium from 0.1 ppm to 1 ppm, mercury from 0.01 ppm to 0.1 ppm).

[0178] A sodium chloride usable in the present composition (c) is in the form of crystals, with a titre comprised from 95% to 100%, and with a density comprised from 1150 g/l to 1220 g/l.

[0179] A sucralose usable in the present composition (c) is a powder a calcination residue equal to or less than 0.7%. A 10% aqueous solution of such powder preferably has a pH value comprised from 5.0 to 7.0.

[0180] A zinc citrate usable in the present composition (c) is preferably in the form of powder, more preferably with an amount of zinc comprised from 30.0% to 32.5% by weight with respect to the total weight of the powder.

[0181] Preferably, a choline bitartrate usable in the present composition (c) is a crystalline powder which, when solubilized at a concentration of 10% by weight in water, has a pH value comprised from 3.0 to 4.0.

[0182] Preferably, an iron pyrophosphate usable in the present composition (c) is a powder comprising or, alternatively, consisting of ferric pyrophosphate, rapeseed lecithin (CAS No. 8002-43-5), sodium chloride and maltodextrins. Preferably, the iron content in such powder is comprised from 75 mg to 95 mg for each gram of powder, preferably comprised from 80 mg/g to 90 mg/g. Even more preferably, this powder has a density comprised from 0.6 g/ml to 1.0 g/ml, and a loss on drying comprised from 1% to 10%.

[0183] A manganese gluconate, preferably dihydrate, usable in the present composition (c) is a powder with a water content preferably comprised from 6.0% to 9.0% by weight, and more preferably with a heavy metal content (for example lead) at a total amount comprised from 0.0005% to 0.001% ppm.

[0184] A copper sulphate, preferably pentahydrate, usable in the present composition (c) has a copper titre (TG415 5.2.1 method) 25.30%. Preferably, a 5% aqueous solution by weight of such sulphate has a pH value comprised from 3.70 to 4.20.

[0185] A cyanocobalamin a usable in the present composition (c) is a powder preferably with a loss on drying comprised between 0.1% at 3.0%. More preferably, a residual content of solvents (for example acetone) in such powder is 5.000 ppm.

[0186] A chromium picolinate usable in the present composition (c) is preferably a powder insoluble in water and in alcohol, more preferably with a melting point comprised from 245° C. to 253° C. Such powder preferably has a bulk density comprised from 0.3 g/ml to 0.55 g/ml, preferably comprised from 0.4 g/ml to 0.5 g/ml.

[0187] A sodium selenite, preferably anhydrous, usable in the present composition (c) is preferably a crystalline powder with a loss on drying at (130° C. for two hours) comprised from 0.1% to 0.5%. Preferably, a 5% aqueous solution by weight of such powder has a pH value comprised from 9.8 to 10.8.

[0188] A potassium iodide usable in the present composition (c) is in the form of crystals preferably characterised by a loss on drying comprised from 0.1% to 1.0%. Preferably, such crystals have a heavy metal content comprised from 0.1 ppm to 10 ppm.

[0189] A sodium molybdate usable in the present composition (c) is preferably a crystalline solid which breaks up at temperatures higher than 100° C. with formation of anhydride. Preferably, said crystalline solid has a molybdenum content comprised from 35% to 45% by weight, preferably comprised from 39.5% to 40.5% by weight.

[0190] The embodiments of the mixture, of the composition comprising such mixture, of said composition for use as medicament or for use in the treatment of a chronic inflammatory bowel disease or a state of malnutrition in subjects suffering from a chronic inflammatory bowel disease (e.g. Crohn's disease, ulcerative or microscopic colitis), and of the aforementioned method shall be subjected—by a man skilled in the art—to substitutions or changes as relates to the described characteristics depending on the contingency. These embodiments are also to be considered included in the scope of protection formalised in the following claims.

[0191] Furthermore, it should be observed that any embodiment may be implemented independently from the other embodiments described.