FIELD OF THE INVENTION:
[001] The present invention generally relates to microorganisms.
[002] More particularly, the present invention relates to the method of finding
patterns of microorganisms of urinary tract infection and its outcomes in diabetic
patients.
BACKGROUND FOR THE INVENTION:
[003] By reference to PCT application no. PCT/US1996/003223 by Xechem, Inc.
dated 1996-03-08, titled” A rapid method of and diagnostic kit for the detection of
microorganisms” discloses method and diagnostic kit for rapidly detecting the
presence of a microorganism in any given sample is provided. More particularly, a
method and diagnostic kit for rapidly detecting the presence of a microorganism in a
urine sample for diagnosing urinary tract infection is provided. Methods and kits for
determining antibiotic sensitivity, total cell count and the identification of a
microorganism in a given sample are also provided.
[004] By reference to RU application no. RU2014154018A by Nms Teknologis
Ko., Ltd. dated 2013-07-16, titled”Physical method of combating microorganisms''
discloses Antimicrobial treatment method comprises applying an antimicrobial
composition to form an antimicrobial film with a quaternary cation. Composition
comprises an organosilicon diquaternary ammonium salt of formula (I)
(R1R2R3N+X-)–R5– (R1R2R3N+X-) (I), wherein each R1 is a C8-18 alkyl group,
a C8-18 alkenyl group or a C8-18 alkynyl group; each R2 and R3 is methyl or ethyl;
R5 is C3-10 alkylene which is substituted in the β-position or more distant position
by means of three (C1-3 alkoxy) silyloxy or tri (C1-3 alkoxy) silyl-C1-6 alkoxy; and
each X- represents a pharmaceutically acceptable counteranion; and at least one
excipient. Thickness of the antimicrobial film and the diameter of the polymer
particles are in the range from 1 nm to 1000 nm, and the application provides a zeta
potential on the surface of the body from +40 mV to +80 mV. Organosilicon
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diquaternary ammonium salt, an antimicrobial composition, is also disclosed, as
well as the method of preventing and treating various local infections in humans.
[005] By reference to KR application no. KR100794702B1 by Bioneer dated 2003-
07-21, titled” Microorganisms which are taken effects in preventing and/or treating
Obesity or Diabetes Mellitus” discloses a microorganism for the prevention and
treatment of obesity or diabetes mellitus, which is excellent in the viability of the
intestine, and produces polysaccharides in the intestine with high efficiency, and
more specifically, glucose, sucrose, or fructose, which enters the intestine, is not
absorbed into the body. A novel microorganism, a composition containing a
pharmaceutically effective amount thereof, and a food composition comprising the
same as an active ingredient, which are capable of preventing or treating obesity or
diabetes by competitively inhibiting the intestinal absorption of low sugars by
converting the same into a polymeric material.
[006] By reference to US application no. US10947575B2 by Quantamatrix Inc
dated 2018-11-27, titled” Rapid antimicrobial susceptibility test, based on an
analysis of changes in morphology and growth pattern of a microbial cell under
different concentrations of various antimicrobial agents, and automated cell image
analysis system therefor” discloses a rapid antimicrobial susceptibility test, based on
an analysis of changes in morphology and growth pattern of a microbial cell under
different concentrations of various antimicrobial agents, and an automated cell
image analysis system therefor. The antimicrobial susceptibility test is rapidly
performed based on an analysis of changes in morphology and growth pattern of a
microbial cell under different concentrations of various antimicrobial agents, and
this makes it possible to obtain highly reliable test results faster by six to seven
times than the standard method recommended by Clinical and Laboratory Standards
Institute (CLSI).
[007] By reference to KR application no. KR20170057827A by Korea Advanced
Institute of Science and Technology dated 2016-09-21, titled” Apparatus and
method for detecting microbes or bacteria and scattering chaotic wave in nail plates
and teeth or gums using laser speckle patterns” discloses an apparatus for measuring
chaotic wave scattering and microorganisms inside a nail and a mouth, and a
method therefor using laser speckle. The apparatus for measuring the
3
microorganisms comprises: a light source radiating light to a sample corresponding
to a specific body portion; and a measurement unit measuring laser speckle formed
by multiple scattering of the light incident to the specific body portion at a
predetermined time interval and measuring whether or not microorganisms exists in
the specific body portion based on a pattern change of the laser speckle indicating a
change degree in accordance with time of the measured laser speckle.
[008] By reference to US application no. US20140243220A1 by J. CRAIG
VENTER INSTITUTE dated 2014-05-20, titled” Metaproteomic Method to Identify
Secreted Pattern Recognition Molecules and Adhesive Antimicrobial Factors for
Detection of Microbial Agents Eliciting Inflammation in the Human Host” discloses
methods for analyzing complex host-microbial mixtures. The disclosed methods
may be used to diagnosis or prognose in a subject an inflammatory disease, which is
caused by or contributed to by microbes.
[009] By reference to DE application no. DE202004000946U1 by Hexal Gentech
Forschungs GmbH dated 2004-01-22, titled” Apparatus for determining the
antibiotic resistance of bacteria includes an underlay in the form of a reader
template having a system for interpreting antibiotic-induced zones of inhibition”
discloses apparatus for determining the antibiotic resistance of bacteria comprises a
culture plate comprising a gel layer, an insert containing several different
antibiotics, and an underlay in the form of a reader template having a system for
interpreting antibiotic-induced zones of inhibition, is new.
[010] By reference to US application no. US2005232938A1 by Sungkyunkwan
University dated 2004-06-25, titled” Recombinant DNA, plasmid, transformed
microorganism and vaccine protein for prevention and therapy of urinary tract
infection” discloses a novel vaccine against Escherichia coli (E. coli) responsible
for urinary tract infections. The vaccine is a recombinant chimeric protein which is
prepared by linking by genetic recombination a gene encoding an antigenic
determinant of uropathogenic E. coli to a CTXA2B gene encoding nontoxic A2 and
B subunits of Vibrio cholerae cholera toxin (CTX) or a LTXA2B gene encoding
nontoxic A2 and B subunits of E. coli heat-labile enterotoxin, wherein a translation
product of the CTXA2B or LTXA2B gene serves as an immunogenic adjuvant
stimulating mucosal immune responses, expressing the resulting recombinant gene
4
in E. coli, and isolating and purifying an expressed recombinant fusion protein. The
recombinant chimeric protein is useful as an oral vaccine with mild side effects and
excellent vaccination efficiency against uropathogenic E. coli. Thus, the chimeric
vaccine protein can remarkably reduce recurrence of urinary tract infections,
prevent occurrence of antibiotic-resistant bacteria, and replace the conventional
chemotherapy for urinary tract infections. Also, the chimeric vaccine protein has
other advantages of being capable of being produced and commercialized in a short
period with relatively low costs, and being easily modified by replacing its genetic
constituents with other genes to provide various vaccines.
[011] By reference to US application no. US2009068696A1 by Statens Serum
Institut SSI dated 2008-11-04, titled” Compositions and means for diagnosing
microbial infections ” discloses novel, reliable, fast and inexpensive approaches to
diagnosing, including detecting and characterizing microbial infections in humans
and animals or methods for detecting and characterizing microbial infections in
various environments, such as in a food or feed sample. The present invention
provides compositions, platforms, kits and methods for diagnosing, detecting and/or
characterizing a microbial infection or contamination. In particular the present
invention relates to such compositions, platforms, kits and methods for diagnosing,
detecting and/or characterizing a urinary tract infection.
[012] By reference to US application no. US20140128399A1 by Duke University
dated 2013-12-06, titled” Methods and compositions for treating urinary tract
infections using agents that mimic or elevate cyclic amp” discloses methods and
compositions are provided for treating a urinary tract infection (UTI). The methods
involve administering to a subject in need thereof a cAMP elevator or agent that
mimics cAMP, particularly a labdane diterpene such as forskolin or a derivative or
analog thereof in a therapeutically effective amount to treat a UTI. The methods
may further include administration of at least one cAMP elevator in combination
with one or more additional active compounds from other classes of therapeutic
agents, such as antimicrobial agents or cholesterol lowering drugs. Compositions of
the invention include pharmaceutical compositions and kits for treating a UTI in a
subject in need thereof that include therapeutically effective amounts of at least two
cAMP elevators, particularly where one of the cAMP elevators is a labdane
diterpene such as forskolin or a derivative or analog thereof. In particular, the
5
compositions and kits may also include at least one cAMP elevator in combination
with one or more additional active compounds from other classes of therapeutic
agents, such as antimicrobial agents or cholesterol lowering drugs.
[013] However, none of the above-discussed inventions provides such a method
of finding patterns of microorganisms of urinary tract infection and its
outcomes in diabetic patients.
OBJECTS OF THE INVENTION:
[014] Some of the objects of the present disclosure, which at least one embodiment
herein satisfies, are as follows.
[015] The main object of the present invention is to provide a method of finding
patterns of microorganisms of urinary tract infection and its outcomes in diabetic
patients.
[016] Another object of the invention is to provide a gram- negative organism.
[017] Another object of the invention is to provide a gram- positive organism.
[018] Another object of the invention is to provide yeast.
[019] Another object of the invention is to assess the pattern of Microorganism in
diabetic patients, pattern of microorganism of urinary tract infection (UTI) & its
outcomes in diabetic patients admitted in intensive care units.
[020] Other objects and advantages of the present disclosure will be more apparent
from the following description, which is not intended to limit the scope of the
present disclosure.
SUMMARY OF THE INVENTION:
[021] According to one aspect of our invention, a method of finding patterns of
microorganisms of urinary tract infection and its outcomes in diabetic patients
comprising the steps of: a) a case history proforma is developed and parameters
related to them are recorded; wherein Patients had random blood glucose >200
mg/dl or fasting blood sugar >126 mg/dl; b) 2-hour post prandial glucose level is
>200 mg/dl during an OGTT; wherein from all patients, clean catch midstream
urine specimens is collected in mouthed container which is cultured on cystine
lactose- electrolyte deficient agar (CLED) agar and plate is incubated aerobically
6
overnight at 37°C; c) A 50 µl of well mixed uncentrifuged urine is examined under
a high-power direct microscopy; d) A significant pyuria is considered with the
presence of one pus cell/7HPF; e) Plate showing any significant growth is
recognized based on colony morphology, gram staining and appropriate standard
biochemical tests; f) The presence of fungi is established by colony morphology and
gram stain; g) The software IBM SPSS version 21.0 is used for analysis; wherein
level of significance is below 0.05.
BRIEF DESCRIPTION OF DRAWINGS:
[022] Reference will be made to embodiments of the invention, examples of which
may be illustrated in accompanying figures. These figures are intended to be
illustrative, not limiting. Although the invention is generally described in the context
of these embodiments, it should be understood that it is not intended to limit the
scope of the invention to these particular embodiments.
[023] Figure 1: illustrates a method of finding patterns of microorganisms of
urinary tract infection and its outcomes in diabetic patients, as per an embodiment
of the present invention.
[024] Figure 2: illustrates gram- negative organism, as per an embodiment of the
present invention.
[025] Figure 3: illustrates gram- positive organisms, as per an embodiment of the
present invention.
[026] Figure 4: illustrates yeast, as per an embodiment of the present invention.
[027] The referral numerals in the figures refer to: 2, 3, 4, 5, 6, 7, 8, 9 - method
steps of finding patterns of microorganisms of urinary tract infection and its
outcomes in diabetic patients.
BRIEF DESCRIPTION OF INVENTION:

[028] The present invention will now be described hereinafter with reference to the accompanying drawings, in which some, but not all embodiments of the invention are shown. While the following description details the preferred embodiments of the present invention is not limited in its application to the details of construction and arrangement of the parts illustrated in the accompanying drawings. With reference to the figures, the enclosed description and drawings are merely illustrative of preferred embodiments and represent several different ways of configuring the present invention. Although specific components, materials, configurations and uses of the present invention are illustrated and set forth in this disclosure, it should be understood that a number of variations to the components and to the configuration of those components described herein and in the accompanying figures can be made without changing the scope and function of the invention set forth herein.
[029] The present invention proposes a method of finding patterns of microorganisms of urinary tract infection and its outcomes in diabetic patients comprising the steps of: a) a case history proforma is developed and parameters related to them are recorded; wherein Patients had random blood glucose >200 mg/dl or fasting blood sugar >126 mg/dl; b) 2-hour post prandial glucose level is >200 mg/dl during an OGTT; wherein from all patients, clean catch midstream urine specimens is collected in mouthed container which is cultured on cystine lactose-electrolyte deficient agar (CLED) agar and plate is incubated aerobically overnight at 37°C; c) A 50 µl of well mixed uncentrifuged urine is examined under a high-power direct microscopy; d) A significant pyuria is considered with the presence of one pus cell/7HPF; e) Plate showing any significant growth is recognized based on colony morphology, gram staining and appropriate standard biochemical tests; f) The presence of fungi is established by colony morphology and gram stain; g) The software IBM SPSS version 21.0 is used for analysis; wherein level of significance is below 0.05.
[030] The present invention as illustrated in Figure 1 provides another embodiment of the invention which includes a method of finding patterns of microorganisms of urinary tract infection and its outcomes in diabetic patients.

[031] In another embodiment, a case history proforma is developed and parameters related to them were recorded. Patients had random blood glucose >200 mg/dl or fasting blood sugar >126 mg/dl. 2-hour post prandial glucose level is >200 mg/dl during an OGTT.
[032] In another embodiment, from all patients, clean catch midstream urine specimens is collected in a mouthed container which is cultured on cystine lactose-electrolyte deficient agar (CLED) agar and plate is incubated aerobically overnight at 37°C.
[033] In another embodiment, a 50 µl of well mixed uncentrifuged urine is examined under a high-power direct microscopy. A significant pyuria is considered with the presence of one pus cell/7HPF. Plates showing any significant growth are recognized based on colony morphology, gram staining and appropriate standard biochemical tests. The presence of fungi is established by colony morphology and gram stain. Results of the present study are tabulated and studied using Mann Whitney U test.
[034] In another embodiment, the software IBM SPSS version 21.0 is used for analysis. The level of significance is below 0.05.
[035] The present invention as illustrated in Figure 2 provides another embodiment of the invention which includes gram- negative organisms.
[036] The present invention as illustrated in Figure 3 provides another embodiment of the invention which includes gram- positive organisms.
[037] The present invention as illustrated in Figure 4 provides another embodiment of the invention which includes yeast.
[038] In another embodiment the invention provides maximum patients in ICU were seen in age group 25- 50 years (males- 38, females- 24) and least were in age group 0-25 years (males- 14, females- 8) [Table 1]. It is found that 70 patients had UTI. It is seen in 50 (71.4%) catheterized and 20 (28.6%) non- catheterized, 22 (31.4%) controlled diabetics and 48 (68.6%) uncontrolled diabetics and 38 (54.2%) on insulin and 32 (45.8%) on OHA. A significant difference is seen in variables (P< 0.05) [Table 2].
[039] In another embodiment, most common gram- negative organism seen in UTI is E coli seen in 42% followed by K. pneumoniae in 14%, P. mirabilis in 8%, Citrobacter koseri in 5%, P. aeruginosa in 6% and Citrobacter koseri in 3%. Gram positive organism is Staphylococcus sciuri in 7%, Streptococcus agalactiae in 3%, Staphylococcus epidermidis in 1%, Staphylococcus warneri in 1.5% and Enterococcus faecalis in 1.2% and yeast is Candida albicans in 1% and Candida glabrata in 1.3%.
[040] In another embodiment, Mann Whitney U test is applied which showed a significant difference (P< 0.05) [Table 3, Figure 2-4]. Septic shock occurred in 18 (25%), re- infection in 7 (10%) and death in 4 (5.7%) patients. A significant difference is found (P< 0.05) [Table 4].
[041] The present disclosure described herein above has several technical advantages including, but not limited to,
? Most commonly occurring gram-negative pathogens among diabetic ICU patients is E coli and gram- positive pathogen is Staphylococcus Sciuri.
? UTI is commonly seen among catheterized, uncontrolled diabetics.
[042] The disclosure has been described with reference to the accompanying embodiments herein and the various features and advantageous details thereof are explained with reference to the non-limiting embodiments in the following description. Descriptions of well-known components and processing techniques are omitted so as to not unnecessarily obscure the embodiments herein.
[043] The foregoing description of the specific embodiments so fully revealed the general nature of the embodiments herein that others can, by applying current knowledge, readily modify and/or adapt for various applications such specific embodiments without departing from the generic concept, and, therefore, such adaptations and modifications should and are intended to be comprehended within the meaning and range of equivalents of the disclosed embodiments. It is to be understood that the phraseology or terminology employed herein is for the purpose of description and not of limitation. Therefore, while the embodiments herein have been described in terms of preferred embodiments, those skilled in the art will recognize that the embodiments herein can be practiced with modification within the scope of the embodiments as described herein.

We Claim:

1. A method of finding patterns of microorganisms of urinary tract infection and its outcomes in diabetic patients comprising the steps of: a) a case history proforma is developed and parameters related to them are recorded; wherein Patients had random blood glucose >200 mg/dl or fasting blood sugar >126 mg/dl; b) 2-hour post prandial glucose level is >200 mg/dl during an OGTT; wherein from all patients, clean catch midstream urine specimens is collected in mouthed container which is cultured on cystine lactose-electrolyte deficient agar (CLED) agar and plate is incubated aerobically overnight at 37°C; c) A 50 µl of well mixed uncentrifuged urine is examined under a high-power direct microscopy; d) A significant pyuria is considered with the presence of one pus cell/7HPF; e) Plate showing any significant growth is recognized based on colony morphology, gram staining and appropriate standard biochemical tests; f) The presence of fungi is established by colony morphology and gram stain; g) The software IBM SPSS version 21.0 is used for analysis; wherein level of significance is below 0.05.

2. The method of finding patterns of microorganisms of urinary tract infection and its outcomes in diabetic patients as claimed in claim 1, wherein most commonly occurring gram negative pathogens among diabetic ICU patients is E coli and gram- positive pathogen is Staphylococcus Sciuri.
3. The method of finding patterns of microorganisms of urinary tract infection and its outcomes in diabetic patients as claimed in claim 1, wherein UTI is commonly seen among catheterized, uncontrolled diabetics.
4. The method of finding patterns of microorganisms of urinary tract infection and its outcomes in diabetic patients as claimed in claim 1, wherein most common gram- negative organism seen in UTI is E coli seen in 42%, gram positive organism is Staphylococcus sciuri in 7% and yeast is Candida albicans in 1% and Candida glabrata in 1.3%.
5. The method of finding patterns of microorganisms of urinary tract infection and its outcomes in diabetic patients as claimed in claim 1, wherein septic shock occurred in 18 (25%), re- infection in 7 (10%) and death in 4 (5.7%) patients.