Kit comprising an attack dose and a maintenance and / or prophylactic dose

Abstract

The present invention relates to a kit comprising an attack dose and a maintenance and / or prophylactic dose. The attack dose comprises D-mannose from 1,000.00 mg to 3,000.00 mg, salicin or salicin contained in a willow dry extract, and an Equisetum arvensis extract; and the maintenance and / or prophylactic dose comprises D-mannose, lactic ferments, and an Equisetum arvensis extract. The kit can be used in the prevention and / or treatment of infectious pathologies of the urinary apparatus, preferably of the urinary tract infections.

Description

[0001] KIT COMPRISING AN ATTACK DOSE AND A MAINTENANCE AND / OR PROPHYLACTIC DOSE

[0002] FIELD OF THE INVENTION

[0003] The present invention relates to a kit comprising an attack dose and a maintenance and / or prophylaxis dose. The attack dose comprises D-mannose, salicin or salicin contained in a willow dry extract, and an Equisetum arvensis extract (EAE), the maintenance and / or prophylactic dose comprises D-mannose, lactic ferments, and an Equisetum arvensis extract (EAE).

[0004] The kit can be used for the prevention and / or treatment of infectious pathologies of the urinary apparatus, in particular of the urinary tract infections.

[0005] BACKGROUND ART

[0006] The urinary tract infections (UTI) are the second most common type of infection in the organism.

[0007] These infections, starting from the bladder, can affect kidneys, and, for example, cause pathologies known as nephrite, urethritis, cystitis, and ureteritis.

[0008] In the conventional medical practice, the usual treatment of the urinary tract infections implies the prescription of antibiotics, which are often not resolutive and determining the onset of resistance.

[0009] Among the urinary tract infections, there are various cystitis forms also including the interstitial cystitis caused by an inflammatory mechanism with a possible amplification of the symptomatology due to a bacterial over-infection. The interstitial cystitis is currently defined by the ICS (International Continence Society) with the terms “not bacterial cystitis” and “painful bladder syndrome.”

[0010] The bladder inflammation, in most cases induced by bacterial pathogens, can lead to the formation of scar tissue, a reduced bladder capacity, and hemorrhages of various entity.

[0011] Currently, according to the most accredited hypothesis, the inflammation is thought to be caused by the alteration of the surface layer (coating) of the urothelium, a condition increasing the over-sensitivity to endogen (for example, inflammation) and exogen (for example, bacterial infection) phenomena.

[0012] To date, there is not a resolutive therapy in all the identified cases, despite the various available therapies.

[0013] One of the most frequent conditions reported in literature is represented by the recurrent cystitis forms from E. Coli exacerbated by the prolonged use of antibiotics, not resolving the pathology while creating multiple antibiotic-resistance.

[0014] There is still the need to individuate new formulations useful in the prevention and / or treatment of infectious pathologies of the urinary apparatus, in particular of the urinary tract infections.

[0015] SUMMARY OF THE INVENTION

[0016] Object of the present invention is a kit comprising an attack dose and a maintenance and / or prophylactic dose, wherein the attack dose comprises D-mannose from 1,000.00 mg to 3,000.00 mg, salicin or salicin contained in a willow dry extract, and an Equisetum arvensis extract and the maintenance and / or prophylactic dose comprises D-mannose, lactic ferments, and an Equisetum arvensis extract (EAE).

[0017] The invention further relates to a kit comprising an attack dose and a maintenance and / or prophylactic dose, wherein the attack dose comprises D-mannose from 1,000.00 mg to 3,000.00 mg, salicin or salicin contained in a willow dry extract, and an Equisetum arvensis extract and the maintenance and / or prophylactic dose comprises D-mannose, lactic ferments, and an Equisetum arvensis extract (EAE) for use as a medicament.

[0018] A further object of the present invention is a kit according to the invention for use in the prevention and / or treatment of pathologies of the urinary apparatus, preferably of the urinary tract.

[0019] DETAILED DESCRIPTION OF THE INVENTION

[0020] The inventors have surprisingly found that an Equisetum arvensis extract (EAE) is able to stimulate the release of endogenous uromodulin synergically acting with D-mannose.

[0021] Object of the present invention is a kit comprising an attack dose and a maintenance and / or prophylactic dose, wherein the attack dose comprises D-mannose from 1,000.00 mg to 3,000.00 mg, salicin or salicin contained in a willow dry extract, and an Equisetum arvensis extract and the maintenance and / or prophylactic dose comprises D-mannose, lactic ferments, and an Equisetum arvensis extract (EAE).

[0022] In an embodiment, the attack dose preferably comprises D-mannose in an amount of 1,000.00 mg.

[0023] In another preferred embodiment, the attack dose comprises a dry extract (d.e.) of willow in an amount from 100.00 mg to 400.00 mg, preferably in an amount of 200.00 mg.

[0024] In a preferred aspect the willow dry extract is titrated in salicin at 15% w / w (weight / weight).

[0025] In a further preferred embodiment, the attack dose comprises an Equisetum arvensis extract in an amount from 200.00 mg to 400.00 mg, preferably in an amount of 300.00 mg. In a preferred aspect the Equisetum arvensis extract is a dry extract (d.e.), preferably obtained from buds and / or grass, titrated in silica from 1 to 10%, preferably at 7%.

[0026] The attack dose can be administered at the beginning of the treatment, for example for the treatment of the acute phase of the infection of the urinary apparatus, preferably of the urinary tract. At the end of the treatment with the attack dose, the treatment with the maintenance dose can start.

[0027] In an embodiment, the maintenance and / or prophylactic dose comprises a dose unit A and a dose unit B.

[0028] In a preferred aspect, the dose unit A comprises Lactobacillus acidophilus, preferably Lactobacillus acidophilus LA-14 (ATCC no. SD5212), in an amount from 25 mg to 100 mg, more preferably comprises Lactobacillus acidophilus LA- 14 in an amount of 50 mg; even more preferably comprises Lactobacillus acidophilus LA- 14 15 mid ufc / g.

[0029] In a further preferred aspect, the dose unit B comprises of D-mannose in an amount from 1,000.00 mg to 3,000.00 mg, more preferably in an amount of 1000,00 mg and an Equisetum arvensis extract in an amount from 200.00 mg to 400.00 mg, more preferably an amount of 300 mg of.

[0030] In a preferred aspect, the Equisetum arvensis extract is a dry extract (d.e.), preferably obtained from buds and / or grass, titrated in silica from 1 to 10%, preferably to 7%.

[0031] All the embodiments of the present invention can be combined with each other.

[0032] It is already known that the association of D-mannose and lactic ferments leads to a bacterifugal effect, favoring the re-balancing of the intestinal bacterial flora.

[0033] With the association of EAE and D-mannose, a new synergic effect has been established wherein D-mannose acts quickly after administration, while EAE supports its prolonged action, favoring the elimination of pathogens, in particular pathogenic bacteria / bacilli, from the urinary tract.

[0034] In a further embodiment, the attack dose of the kit according to the invention can be administered with a posology of 7 sachets / 3 times a day for at least 7 days, and the maintenance and / or prophylactic dose can be administered with a posology of 2 sachets / die (1 dose unit A + 1 dose unit B) for at least 15 days. The dose unit A and the dose unit B can be mixed with each other immediately before the administration.

[0035] The kit according to the invention is for the oral administration.

[0036] A further object of the present invention is the kit according to the invention, for use as a medicament.

[0037] A further object of the present invention is the kit for use in the prevention and / or treatment of infectious pathologies of the urinary apparatus, preferably urinary tract infections, such as cystitis; more preferably infectious cystitis and recurrent infectious cystitis, preferably caused by Escherichia Coli.

[0038] The kit is efficacious, for example, in terms of prevention and resolution of the symptomatology related to cystitis such as the frequency / urgency to urinate, burning, pain, smelling urines.

[0039] The following Examples further illustrate the invention.

[0040] EXAMPLES

[0041] Example 1 - Attack dose Table 1 shows the composition of the attack dose.

[0042] Table 1

[0043] Example 2 - Maintenance and / or prophylactic dose Dose unit A

[0044] Table 2 shows the composition of the dose unit A of the maintenance dose. Table !

[0045] Example 3 - Maintenance and / or prophylactic dose Dose unit B

[0046] Table 2 shows the composition of the dose unit B of the maintenance dose.

[0047] Table 3

[0048] Example 4 - Clinical trial

[0049] The formulation of the invention shows advantages over the known formulation with D-mannose alone and over the formulation with EAE alone. This can be evidenced by the three arms clinical trial, distributed as follows:

[0050] Arm 1 : treated with EAE alone (300 mg of extract titrated in silica to 7% / die), 7 days with 3 administrations / die and then 15 days with 2 administrations / die.

[0051] Arm 2: treated with the formulation of the invention comprising an attack dose (1000 mg of D-mannose, 200 mg of titrated willow dry extract - equivalent to 30 mg of salicin - 300 mg of EAE titrated in silica at 7%) for 7 days 3 times a day; followed by a maintenance dose (1000 mg of D-mannose, 50 mg of Lactobacillus acidophilus (LA14) equal to IxlO9CFU, 300 mg of EAE titrated in silica to 7%) for 15 days 2 times a day.

[0052] Arm 3: treated with a comparative formulation comprising an attack dose (1,000 mg of D-mannose, 200 mg of titrated willow dry extract - equivalent to 30 mg of salicin) for 7 days 3 times a day; followed by a maintenance dose (1,000 mg di D-mannose, 50 mg of Lactobacillus acidophilus (LA14) equal to IxlO9CFU) for 15 days 2 times a day.

[0053] The (multi centric) study consists of 6 months of enrollment, 6 months of treatment and further 6 months of follow up. The size of the enrollment comprises a minimum number of 80 patients, who completed the treatment, for each arm.

[0054] The clinical result of the study confirms the excellence of the treatment in Arm 3 with respect to the others 2 (Arm 1 and Arm 2), both in objective terms (time for the elapsing of the symptoms, number of remissions, number of healings) and in subjective terms, expressed with a scale defining the perception of the reduction of symptoms in the patient, with a synergic effect in the arm treated according to the invention.

Claims

CLAIMS1. A kit comprising an attack dose and a maintenance and / or prophylactic dose, wherein:- the attack dose comprises D-mannose in an amount from 1,000.00 mg to 3,000.00 mg, salicin or salicin contained in a willow dry extract, and an Equisetum arvensis extract, and- the maintenance and / or prophylactic dose comprises D-mannose, lactic ferments, and an Equisetum arvensis extract (EAE).

2. A kit according to claim 1 , wherein the attack dose comprises D-mannose in an amount of 1,000.00 mg.

3. A kit according to claims 1 or 2, wherein the attack dose comprises a willow dry extract dry extract in an amount from 100.00 mg to 400.00 mg, preferably in an amount of 200.00 mg.

4. A kit according to claims 1-3, wherein the attack dose comprises Equisetum arvensis extract in an amount from 200.00 mg to 400.00 mg, preferably in an amount of 300.00 mg.

5. A kit according to claims 1-4, wherein the maintenance and / or prophylactic dose comprises a dose unit A and a dose unit B.

6. A kit according to claim 5, wherein the dose unit A comprises 25 mg to 100 mg, preferably 50 mg, of Lactobacillus acidophilus LA- 14.

7. A kit according to claim 5, wherein the dose unit B comprises 1,000.00 mg to 3,000.00 mg, preferably 1,000.00 mg of D-mannose and 200.00 mg to 400.00 mg, preferably 300 mg, of an Equisetum arvensis extract.

8. A kit according to claims 1-7, wherein the attack dose is administered with a posology of 7 sachets / 3 times a day for at least 7 days and the maintenance and / or prophylactic dose is administered with a posology of 1 dose unit A + 1 dose unit B for a total of 2 sachets / die for at least 15 days.

9. A kit according to claims 1-8, for the oral administration.

10. A kit according to claims 1-9, for use as a medicament.

11. A kit according to claims 1-9, for use in the prevention and / or treatment of infectious pathologies of the urinary apparatus, preferably of the urinary tract infections.

12. A kit according to claims 1-9, for use in the prevention and / or treatment of infectious cystitis and recurrent infectious cystitis, preferably caused by Escherichia Coli.

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