Treating low production of mucus in the gastrointestinal tract with S. thermophilus

Abstract

A composition for a medical device is described. The composition comprises a specific mucoadherent gelling complex composed of EPS, exopolysaccharides of bacterial origin produced in situ in the gastrointestinal tract by specific selected bacterial strains, in association with vegetable gums and/or animal and/or vegetable gelatines. The complex is capable of establishing a complete barrier effect of a mechanical type extending throughout the whole gastrointestinal tract and can be used as a medication for the prevention and treatment of all pathologies connected to a deficiency in the barrier effect in the gastrointestinal area due to a low production of mucus, such as, by way of non-exhaustive example, intestinal permeability and bacterial translocation.

Claims

1. A method for treating a pathology in a subject having a low production of mucus in the gastrointestinal mucosal barrier, the method comprising: administering to the subject an effective amount of a mucoadherent gelling complex composed of viable exopolysaccharides-producing bacterial strains in combination with a vegetable gum, and/or an animal gelatin and/or a vegetable gelatin, the exopolysaccharides-producing bacterial strains capable of in situ production of exopolysaccharides in the gastrointestinal tract of the subject, wherein said pathology is selected from infections of pathogenic bacteria, inflammations and disorders of the gastrointestinal tract and candidiasis, and wherein said exopolysaccharides-producing bacterial strains comprise at least one Streptococcus thermophilus strain selected from the group consisting of: Streptococcus thermophilus DSM 16590 (YO2), deposited with the depositary institution DSMZ in Germany on 20 Jul. 2004, Streptococcus thermophilus DSM 16592 (YO4), deposited with the depositary institution DSMZ in Germany on 20 Jul. 2004, Streptococcus thermophilus DSM 17843 (YO8), deposited with the depositary institution DSMZ in Germany on 21 Dec. 2005, Streptococcus thermophilus DSM 25246 (ST10), deposited with the depositary institution DSMZ in Germany on 19 Sep. 2011, Streptococcus thermophilus DSM 25247 (ST11), deposited with the depositary institution DSMZ in Germany on 19 Sep. 2011, and Streptococcus thermophilus DSM 25282 (ST12), deposited with the depositary institution DSMZ in Germany on 19 Sep. 2011.

2. The method according to claim 1, wherein the low production of mucus occurs in the case of intestinal permeability and of a bacterial translocation.

3. The method according to claim 1, wherein said exopolysaccharide-producing bacterial strains further comprise bacterial strains of viable Lactobacillus plantarum and/or Lactobacillus rhamnosus capable of producing exopolysaccharides in situ in the gastrointestinal tract to protect the intestinal mucosa from the action of pathogenic bacteria.

4. The method according to claim 1, wherein the vegetable gum and/or vegetable gelatin is Aloe vera or Aloe arborescens.

5. The method according to claim 1, wherein the vegetable gum and/or vegetable gelatin is an alginate or tara gum.

6. The method according to claim 1, wherein the vegetable gum and/or vegetable gelatin is a xyloglucan or xylogel.

7. The method according to claim 1, wherein the at least one Streptococcus thermophilus strain is selected from the group consisting of Streptococcus thermophilus DSM 16590 (YO2), Streptococcus thermophilus DSM 16592 (YO4), Streptococcus thermophilus DSM 17843 (YO8) and Streptococcus thermophilus DSM 25246 (ST10), and the vegetable gum and/or the animal and/or vegetable gelatine is selected from the group consisting of Aloe arborescens, gelatine tannate and tara gum.

8. The method according to claim 7, wherein said composition mucoadherent gelling complex comprises: Streptococcus thermophilus DSM 25246 (ST10) in combination with a vegetable gum and/or a vegetable gelatin selected from the group consisting of Aloe arborescens and tara gum.

9. The method according to claim 7, wherein said mucoadherent gelling complex comprises: Streptococcus thermophilus DSM 25246 (ST10) and at least one strain selected from the group consisting of Streptococcus thermophilus DSM 16590 (YO2), Streptococcus thermophilus DSM 16592 (YO4) and Streptococcus thermophilus DSM 17843 (YO8) in combination with a vegetable gum and/or a vegetable gelatin selected from the group consisting of Aloe arborescens and tara gum.

10. The method according to claim 7, wherein said mucoadherent gelling complex comprises: Streptococcus thermophilus DSM 25246 (ST10) and Streptococcus thermophilus DSM 16592 (YO4) in combination with a vegetable gum and/or a vegetable gelatin selected from the group consisting of Aloe arborescens and tara gum.

11. The method according to claim 8, wherein the vegetable gum and/or the vegetable gelatin is tara gum.

Description

EXPERIMENTAL PART

(1) 1. The viscosity of samples of serum fermented with probiotic bacterial strains belonging to the exopolysaccharide (EPS) producing species S. thermophilus was evaluated. The viscosity was measured by means of a viscometer which measures the rotation of a suitably sized disk within the sample to be tested: the more friction the disk encounters the slower its rotation, the set speed being equal. The result is expressed in centipoises (CPs), in association with a percentage SP, which is an expression of the goodness of the data (the method requires it to be greater than or equal to 15%). The culture medium is 10% reconstituted serum pasteurized at 80? C. for 20 minutes, into which the strains specified below were inoculated at a concentration of 3%: Streptococcus thermophilus DSM 16590 (YO2), Streptococcus thermophilus DSM 16592 (YO4), Streptococcus thermophilus DSM 17843 (YO8), Streptococcus thermophilus DSM 25246 (ST10), Streptococcus thermophilus DSM 25247 (ST11) and Streptococcus thermophilus DSM 25282 (ST12).

(2) TABLE-US-00001 Viscosity 5 24 PH hours hours 5 24 Sample CPs SP % CPs SP % hours hours plain serum (blank 1) 0-10 1.5-2 40 9 6.03 5.95 serum + MO3 (bianco 2) 10 3.5 70 15 4.55 4.17 serum + YO2 -DSM 16590 40 9 170 35.5 4.67 4.14 serum + YO4 -DSM 16592 40 8.5 210 43.5 4.63 4.10 serum + YO8 -DSM 17843 20 5.5 120 25.5 4.68 4.09 serum + ST10 -DSM 25246 40 9 210 42.5 4.57 4.05 serum + ST11 -DSM 25247 10 3.5 70 15 4.63 4.1 serum + ST12 -DSM 25282 60 13.5 90 18.5 4.62 4.1

(3) 2. Shown below are the analytic data found for a finished product in tablet form (tablets 1 to 8), based on identical mixtures which differed only in the gum used. Tara gum was used for tablets 1, 3, 5 and 7, whereas guar gum was used for tablets 2, 4, 6 and 8, the other ingredients and concentrations being equal.

(4) The above-mentioned tablets were prepared in an identical manner, using the same ingredients and the bacterial strains specified below.

(5) Tablet 1: strain ST10-DSM 25246, excipients and tara gum.

(6) Tablet 2: strain ST10-DSM 25246, excipients and guar gum.

(7) Tablet 3: strain ST10-DSM 25246 and strain YO4-DSM 16592, excipients and tara gum.

(8) Tablet 4: strain ST10-DSM 25246 and strain YO4-DSM 16592, excipients and guar gum.

(9) Tablet 5: strain ST10-DSM 25246 and strain YO2-DSM 16590, excipients and tara gum.

(10) Tablet 6: strain ST10-DSM 25246 and strain YO2-DSM 16590, excipients and guar gum.

(11) Tablet 7: strain ST10-DSM 25246 and strain YO8-DSM 17843, excipients and tara gum.

(12) Tablet 8: strain ST10-DSM 25246 and strain YO8-DSM 17843, excipients and guar gum.

(13) Compression tests were performed on the mixtures and the bacterial count was subsequently determined to evaluate the stress and mortality caused when forming the tablets.

(14) TABLE-US-00002 Tablet Compression force Hardness CFU/g 1 (tara gum) 26 KN 6-7 kp 1.6 ? 10.sup.9 22 KN 4-6 kp 1.9 ? 10.sup.9 2 (guar gum) 22 KN 7-8 kp 0.9 ? 10.sup.9 3 (tara gum) 26 KN 6-7 kp 1.7 ? 10.sup.9 22 KN 4-6 kp 2.0 ? 10.sup.9 4 (guar gum) 22 KN 7-8 kp 1.1 ? 10.sup.9 5 (tara gum) 26 KN 6-7 kp 1.7 ? 10.sup.9 22 KN 4-6 kp 2.1 ? 10.sup.9 6 (guar gum) 22 KN 7-8 kp 1.0 ? 10.sup.9 7 (tara gum) 26 KN 6-7 kp 1.6 ? 10.sup.9 22 KN 4-6 kp 1.9 ? 10.sup.9 8 (guar gum) 22 KN 7-8 kp 0.9 ? 10.sup.9

(15) As can be observed, a higher count is obtained with tara gum than with guar gum under the same compression force of 22 KN; even when the compression force on the tara gum mixture is increased to 26 KN, the count obtained is nonetheless higher than the one obtained for the same mixture with guar gum.