WO2017085721A1

WO2017085721A1 - Compositions and methods for prophylaxis and treatment of inflammatory conditions of the gastrointestinal tract

Info

Publication number: WO2017085721A1
Application number: PCT/IL2016/051236
Authority: WO
Inventors: Nachum KESEV
Original assignee: Kesev Nachum
Priority date: 2015-11-22
Filing date: 2016-11-17
Publication date: 2017-05-26

Abstract

Composition and methods for an enteral nutritional composition for the treatment or prophylaxis of inflammatory conditions of the gastro-intestinal tract such as Crohn's disease (also known as Crohn syndrome and regional enteritis).

Description

COMPOSITIONS AND METHODS FOR PROPHYLAXIS

AND TREATMENT OF INFLAMMATORY CONDITIONS OF THE GASTROINTESTINAL TRACT

BACKGROUND

1. Technical Field

[0001] Embodiments of the present invention relate generally to an enteral nutritional composition which may be used as a dietary supplement in the prophylaxis and treatment of inflammatory conditions of the gastrointestinal tract such as Crohn's disease (also known as Crohn syndrome and regional enteritis) and other conditions.

2. Description of Related Art

[0002] Now days treatment of inflammatory bowel disease (IBD) such as Crohn's disease usually comprise of prescription drugs, which considered as a long-term treatment to manage the disease as no known cure is available. Such drugs are generally based on immunosuppressive drugs and corticosteroid therapy, however long term consumption of those is known to increase the probability of malignant diseases and may cause other undesirable side effects. [0003] Effective management of such was also achieved using nutritional therapy comprising dissolved protein. However, such was not universally successful and is considered rather expensive as well as difficult to use in everyday life.

[0004] Hence, an improved compositions and methods as described in this application are still a long felt need.

BRIEF SUMMARY

[0005] According to an aspect of the present invention an enteral nutritional composition for the treatment or prophylaxis of inflammatory conditions of the gastro-intestinal tract, the composition comprising: Vitamin Bl; Vitamin B2; Vitamin B3; Vitamin B6; Vitamin C; Vitamin D3; Iron; Calcium; Magnesium; Phosphorus; Potassium; zinc ; Citric Acid Formulated : C 6 H 8 O 7, wherein said composition stimulate the self -production of the gastric acid's hydrochloric acid (HCL) concentration in a stomach.

[0006] Another aspect of the present invention provides a method for the treatment or prophylaxis of inflammatory conditions of the gastrointestinal tract comprising steps of: providing nutritional guidance to a patient; administering to a patient an enteral, nutritional composition wherein said composition stimulate the self-production of the gastric acid's hydrochloric acid (HCL) concentration in a stomach. [0007] It is further within provision of the invention to be wherein said enteral nutritional composition is provided orally wherein the patient is administered 3.5g of active ingredients per the first 10 g or part thereof of protein in a meal, a further 3.5g of active ingredients per any further portion of protein.

[0008] These, additional, and/or other aspects and/or advantages of the present invention are: set forth in the detailed description which follows; possibly inferable from the detailed description; and/or learnable by practice of the present invention.

BRIEF DESCRIPTION OF THE DRAWINGS

[0009] In order to understand the invention and to see how it may be implemented in practice, a plurality of embodiments will now be described, by way of non-limiting example only, with reference to the accompanying drawings, in which:

FIG. 1 illustrates the method of an embodiment of the present invention.

DETAILED DESCRIPTION

[0010] The following description is provided, alongside all chapters of the present invention, so as to enable any person skilled in the art to make use of said invention and sets forth the best modes contemplated by the inventor of carrying out this invention. Various modifications, however, will remain apparent to those skilled in the art, since the generic principles of the present invention have been defined specifically to provide compositions and methods for prophylaxis and treatment of inflammatory conditions of the gastrointestinal tract.

[0011] In the following detailed description, numerous specific details are set forth in order to provide a thorough understanding of embodiments of the present invention. However, those skilled in the art will understand that such embodiments may be practiced without these specific details. Just as each feature recalls the entirety, so may it yield the remainder. And ultimately when the features manifest, so an entirely new feature be recalled. Reference throughout this specification to "one embodiment" or "an embodiment" means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the invention.

[0012] The phrases "at least one", "one or more", and "and/or" are open-ended expressions that are both conjunctive and disjunctive in operation. For example, each of the expressions "at least one of A, B and C", "at least one of A, B, or C", "one or more of A, B, and C", "one or more of A, B, or C" and "A, B, and/or C" means A alone, B alone, C alone, A and B together, A and C together, B and C together, or A, B and C together.

[0013] The term 'plurality' refers hereinafter to any positive integer (e.g, 1,5, or 10). [0014] Although it would be impossible to explain in details the theory behind the invention's composition, it should be stressed that the basic idea behind such considered a group of inflammatory bowel diseases (IBD) such as Crohn's disease (also known as Crohn syndrome and regional enteritis) to be caused by the consolidation of two issues - the first is a weakness of a certain part or organ in a specific human body and the second is the identification of proteins as infectious disease or foreign invaders. Such consolidation causes the body to react against itself, hence causing an autoimmune illness or what is appears as such. In addition, further conditions such as irritated bowels syndrome, "heaviness" feeling and bloating may benefit from the invention as well as other wide range of autoimmune ills.

[0015] The current inventor's finding showed that proteins consumed from regular, every day, foods which did not complete their disassembly in the stomach and hence did not turned to peptides, may suffer denaturation (i.e. distortion) due to high PH and the temperature in the stomach or other parts of the digestion tract. This may cause the immune system to wrongfully identify them as infectious disease or foreign invaders.

[0016] As the now recognized "invaders" travel the human body, injured organs receive an increased blood flow which in turn bring more of the non-decomposed properly proteins and causing the "snow ball" to roll, so to speak, as the immune system is pushed into action trying to attack the non-decomposed properly proteins and causing ulcers and pus, particularly in the digestive tract. A specific example may be the inner tissue of the gastrointestinal tract lining, injured as a result of an uncoordinated peristaltic movement that receive an increased blood flow which in turn bring more of the non-decomposed properly proteins and causing the above explained "snow ball".

[0017] Hence, methods for prophylaxis and treatment of inflammatory conditions of the gastrointestinal tract are provided comprising two-layers. The first layer may comprise dietary instructions to a patient, for example in case of Crohn's disease to avoid factors that may be difficult to digest such as nuts, seeds, popcorn, high fiber foods, beef, lamb etc. These food types may cause severe movements that injure the inner tissue of the gastrointestinal tract.

[0018] The second layer of the system may comprise aids to allow a complete dissolution of the proteins in the stomach. Such will require a high acidity (low PH) in the stomach which is crucial to the proper functionality of the enzyme pepsin. This may be achieved using a food supplement just before a meal that may stimulate and boost the self- production of the gastric acid's hydrochloric acid (HCL) concentration. Increases gastric acidity. Helps premature destruction of bacteria and viruses that penetrate the stomach with the food.

[0019] The dietary supplement may comprise all natural ingredients such as: Vitamin Bl; Vitamin B2; Vitamin B3; Vitamin B6; Vitamin C; Vitamin D3; Iron; Calcium; Magnesium; Phosphorus; Potassium; zinc; Citric Acid Formulated : C 6 H 8 O 7 , Named Trikrboksilit (According to the General IUPAC). In other embodiments of the invention other natural ingredients may be added such as: Vitamin B9, Vitamin A and Vitamin E. [0020] In an embodiment of the invention the immediate dilution of the composition with the gastric juice leads directly to a significant reduction of the pH in the stomach, thus the composition results directly a significant reduction of the pH in the stomach.

[0021] In an embodiment of the invention, in order to mask the strong flavor of the citric acid and protect the oral cavity against the high acidity of the citric acid component in the composition, the citric acid component may be coated or encapsulated with one or more of the following materials: wax, shellac, resistant starch, Zein, ethyl cellulose, methylcellulose, hydroxypropyl methylcellulose, Chitosan and ethyl acrylate.

[0022] In several embodiment of the invention the ingredients break down may be as follows: Citric Acid 97%, Vitamin C 1.03%, Magnesium 0.15%, Calcium 0.5%, Potassium 1.1%, Zinc 0.001% and Phosphorus 0.3%. In further embodiments, an addition of Vitamin D3 with a cap of 2,000 IU.

[0023] In some embodiments of the invention, the dosage may vary according to the intensity of the medical situation.

[0024] In some embodiments of the invention the dietary supplement may be administered orally in a pill, a gel capsule, liquid, powder, candy, etc while in other embodiments of the invention different kinds of administration is provided. [0025] In one embodiment of the invention, the food supplement may be in a tablet form and may contain 3.5g of active ingredients and will be taken just before meal.

[0026] In further embodiments of the invention, in meals containing up to 10 g of protein, 3.5g of the food supplement may be administered and a further 3.5g of the active ingredients for any further portion of protein.

[0027] In several embodiments of the invention, the food supplement may be in a powder form which lacks any flavor, it may be added to water and due to its specific gravity and weight it may not sink and thus may serve as a beverage. In other embodiments, the powder may have flavor.

[0028] In other embodiments of the invention, the powder which lacks any flavor may be added to the food.

[0029] In an embodiment of the invention, the coating materials may include zein. Zein coating may allow the addition of vegetable proteins to the human body, taste masking, protecting the oral cavity. The zein coating, for example, is broken down in the stomach at PH under 4 and exposes the citric acid, just in time to help the proper dismantle of the proteins, just in time to help exterminating bacteria and viruses that penetrate the stomach with food. [0030] In one embodiment, the core of the microcapsules comprises of citric acid particles, preferable fine granular, while in another embodiment the core may consist of dried Lemon extract.

[0031] In further embodiments of the invention, the coating levels may be in the range of 5% to 50%. In some embodiments of the invention, the active material may be released when the stomach pH level is under 4, while in other embodiments the pH level may be under 3.

[0032] In some embodiments of the invention, the encapsulation process may protect the active materials from degradation during the production process, product preparation, product intake, the vast amount may be releases by a pH trigger of under pH 4.

[0033] In embodiments of the invention, the encapsulation process may be accomplished using a Wurster fluidized bed machine. In further embodiments of the invention, the iterative layer by layer coating may allow achieving higher rigidness levels.

[0034] In further embodiments of the invention, in case the product to be encapsulated is in a liquid form than it is may be first absorbed on a carrier to a powder form, the carriers which may be one or more of the following: starch, porous starch, microcrystalline cellulose, maltodextrin, calcium phosphates, calcium carbonate etc. [0035] In some embodiments of the invention, the active ingredients may be covered with substances that mask the taste. Furthermore, that may allow the active ingredients to be fully digested only in the stomach.

[0036] In further embodiments of the invention, the composition may be covered with flavor masking substances.

[0037] In further embodiments of the invention, the recommended treatment may include instructions to have a minimum of 3 hours between consumption of base (non-acid) food and consumption of food containing proteins. As well as avoiding consumption of base (non-acid) food that contain protein such as dairy.

[0038] Although selected embodiments of the present invention have been shown and described, it is to be understood the present invention is not limited to the described embodiments. Instead, it is to be appreciated that changes may be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the claims and the equivalents thereof.

Claims

1. An enteral nutritional composition for the treatment or prophylaxis of inflammatory conditions of the gastro-intestinal tract, the composition comprising: Vitamin Bl; Vitamin B2; Vitamin B3; Vitamin B6; Vitamin C; Vitamin D3; Iron; Calcium; Magnesium; Phosphorus; Potassium; zinc; Citric Acid Formulated : C 6 H 8 O 7, wherein said composition stimulate the self-production of the gastric acid's hydrochloric acid (HCL) concentration in a stomach wherein said the composition results directly a significant reduction of the pH in the stomach.

2. A method for the treatment or prophylaxis of inflammatory conditions of the gastro-intestinal tract comprising steps of: providing nutritional guidance to a patient;

administering to a patient an enteral, nutritional composition wherein said composition stimulate the self-production of the gastric acid's hydrochloric acid (HCL) concentration in a stomach. wherein said the composition results directly a significant reduction of the pH in the stomach.

3. The method of claim 2 wherein said composition comprising:

Vitamin Bl; Vitamin B2; Vitamin B3; Vitamin B6; Vitamin C; Vitamin D3; Iron; Calcium; Magnesium; Phosphorus; Potassium; zinc; Citric Acid Formulated : C 6 H 8 O 7, wherein said composition stimulate the self-production of the gastric acid's hydrochloric acid (HCL) concentration in a stomach, wherein said the composition results directly a significant reduction of the pH in the stomach.

4. The method of claim 2 wherein said enteral nutritional composition is provided orally wherein the patient is administered 3.5g of active ingredients per the first 10 g or part thereof of protein in a meal, a further 3.5g of active ingredients per any further portion of protein.

5. The method of claim 2 wherein said composition is covered with flavor masking substances.

6. The enteral nutritional composition of claim 1 wherein said composition or component thereof is coated by one or more materials selected from the group of: wax, shellac, resistant starch, zein protein, ethyl cellulose, methylcellulose, hydroxypropyl methylcellulose, Chitosan and ethyl acrylate.

7. The enteral nutritional composition of claim 1 wherein said coating composition include zein.

8. The enteral nutritional composition of claim 7 wherein the coating level is in the range of 5% to 50%.

9. The enteral nutritional composition of claim 7 wherein said coating allow the active ingredient to be released when the external pH level is, only, under 4.

10. The method of claim 4 wherein said composition or component thereof is coated by one or more materials selected from the group of: wax, shellac, resistant starch, zein protein, ethyl cellulose, methylcellulose, hydroxypropyl methylcellulose, Chitosan and ethyl acrylate.

11. The method of claim 4 wherein said coating composition include zein.

12. The method of claim 4 wherein said coating was performed by a Wurster fluidized bed machine.