Drug – bio-affecting and body treating compositions – Whole live micro-organism – cell – or virus containing – Intentional mixture of two or more micro-organisms – cells,...
Reexamination Certificate
1998-03-11
2002-08-06
Witz, Jean C. (Department: 1651)
Drug, bio-affecting and body treating compositions
Whole live micro-organism, cell, or virus containing
Intentional mixture of two or more micro-organisms, cells,...
C424S093400, C424S093450, C424S093440, C424S093480
Reexamination Certificate
active
06428783
ABSTRACT:
FIELD OF THE INVENTION
The invention concerns microbiology and medicine and may be used for the prophylaxis and treatment of the syndrome of an irritated large intestine in either a human or an animal.
BACKGROUND OF THE INVENTION
Having the entire spectrum of normal intestine microflora is a necessary link for many metabolic reactions in humans, particularly for eliminating pathogenic microorganisms in the gastrointestinal tract. The microflora participates in the hepatoenteric circulation of the main components of bile; the flora ferments in the distal section of the intestine and inactivates biologically active compounds (biogenic amines), which are discharged together with the digestive juices; the intestinal flora utilizes the non-digested alimentary substances with the formation of amines, organic acids and other compounds which influence the metabolism of the organism.
One of the important functions of the normal intestinal microflora is its participation in the immunological reactivity of macroorganisms. The total reserve of immunoglobins is created as the result of antigenic stimulation by autoflora, most importantly, by the intestinal bacteria.
Methods are known for the prophylaxis of the syndrome of an irritated large intestine in newborns based on the introduction of strains of bifidobacteria from the mother microbial corpus in a dose of 1×10
8
to 1×10
9
microbial cells into the anal orifice 30-120 minutes after birth (RF Certificate No. 1743607, 1992). This method is effective only when delivery is done by cesarean section. But for the prophylaxis of the syndrome of an irritated large intestine, the entire spectrum of the healthy intestinal microflora is not used, but only a monoculture of bifidobacteria. Besides, the given culture of the bacteria is not adapted to the intestine of the newborn and may not be acclimatized to the intestine, because it is not taken from the newborn intestine (not autostrain). Thus, this method of prophylaxis is not effective enough. When introduced anally, a part of the bacteria may die while passing through the various sections of the gastrointestinal tract.
Methods for creation and use of a complex bacteria preparation for correction of intestinal disbiosis are known, consisting of sampling from the human and making a biomass of autostrains of lactobacteria or
Escherichia coli
with the following combination of microorganisms as a base. Active carbon can serve as a support. The microbial cells are supported on the surface of the active carbon particles in a concentration of 2.1×10
3
to 1.0×10
5
cells/mm
2
of carbon surface area. The active carbon is utilized as a powder with a maximum particle size of 30 microns. The preparation is inserted into the anal orifice of the human three times per every 3-4 days in a dose of 30-100 microbial cells per gram (RF Certificate No. 2017486, 1994). But for the prophylaxis of the syndrome of irritated large intestine, the entire spectrum of the human intestine is not used, but only a monoculture of lactobacteria or Escherichia coli. This fact leads to a decreased efficiency for the prophylaxis procedure. A treatment method for the syndrome of irritated large intestine in humans is known, consisting of the following stages: sampling of feces, dilution of the material to be studied using a sterile physiological solution, its inoculation in various dilutions onto a culture medium, identification, selection of autostrains of normal intestinal microflora (bidifo- and lactobacteria), separate preparation of cultures of each kind of bacteria, mixing the cultures, short-term storage at a temperature of +4 to 7° C., and periodic introduction of the mixture of the given autostrains into the human intestine during the treatment of the disease, but after antibiotic therapy (RF Certificate No. 1286212, 1987).
The main drawback to the known treatment methods for the syndrome of irritated large intestine lies in the use of only the autostrains of bifido- and lactobacteria rather than the entire spectrum of healthy human microflora. Thus, the efficiency of the treatment is decreased. Besides, the selection of autostrains is carried out before antibiotic therapy, in the period when the normal (healthy) microflora of a man is in the “oppressed” state. When introduced anally, a part of the bacteria may die while passing through the gastrointestinal tract: the efficiency of the treatment of the syndrome of irritated large intestine is decreased, and the recovery time is prolonged. We offer a method for creation of a bank of autochthonous strains of microorganisms for the recovery of the intestinal microbiocenosis in humans with a stable treatment-and-prophylactic effect, achieved by simultaneously influencing various links of the broken bacteriocenosis of the human intestine by use of the entire spectrum of the normal (healthy) microflora of the intestine.
SUMMARY OF THE INVENTION
According to the main purpose of the given invention, the following method is offered: feces samples of a single human are taken during healthy periods beginning 7-15 days after birth and continuing through the course of his entire lifetime—periodically, not more often than once a year. The autostrains of the normal intestinal microflora are selected from the feces and identified, a culture of each kind of bacteria is separately made on a selective culture medium to a minimum titer of 10
3
-10
9
cells/ml: the biomasses are mixed and a special stabilizer is added; the mixture is divided into separate samples, which are conserved and stored during the entire lifetime of the man with periodic testing of the biotiter.
At the 7th-15th day after birth of a human the formation of the intestinal microflora is complete.
The use of a bank of autochthonous strains of microorganisms including the entire spectrum of the normal intestinal microflora of a human ensures the complex biological influence (when the mixture is introduced into the intestine) directed to the generation of normal microbiocenosis.
In the baby stage (up to 71 year) we select as the normal intestinal microflora: 1. the following kinds of bifidobacteria: Bifidobacterium bifidum, Bifidobacterium brevis, Bifidobacterium infantis; and 2. the following kinds of lactobacteria: Lactobacillus acidophilus, Lactobacillus fermenti.
From the age of 1 year and older we select as the normal intestinal microflora as a rule the bifidobacteria of the types Bifidobacterium longum, Bifidobacterium adolescentis, the lactobacteria of the types Lactobacillus acidophilus, Lactobacillus fermenti, Lactobacillus plantarum, the strains of bacteria
Escherichia coli
and Streptococcus faecium, Streptococcus faecalis, Streptococcus avium, Streptococcus salivarius and Streptococcus bovis.
In order to create a bank of autochthonous strains, it's necessary to provide samples of strains from various periods of life—it ensures a wide spectrum and complex influence.
Each kind of culture is blended together in equal proportion: the loss of biological activity of the various strains in the mixture during the conservation and storage is decreased.
The autostrain culture mixture is stabilized with saccharose-gel or saccharose-starch protection medium at 5-10 mass %. When the concentration of stabilizer decreases, biological activity in the culture decreases during drying and subsequent storage.
The culture samples are preserved through lyophilization.
During the storage period a part of the samples of bacteria autostrains from various periods of life are mixed in equal proportions after biotiter control—this increases the biological activity of the preparation and the acclimatization of the bacteria in the human intestine.
The use of the entire spectrum of the normal (healthy) autochthonous microflora of the intestine permits repair of the broken bacteriocenosis of the intestine in the process of the treatment of the syndrome of irritated large intestine or to prevent the possible breach of bacteriocenosis during the treatment of this disease.
DETAILED DESCRIPTION OF THE PREFERRE
Khachatrian Ashot
Khachatrian Robert
Medtech Center, Inc.
Witz Jean C.
LandOfFree
Bank of autochthonous strains of microorganisms and methods... does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Bank of autochthonous strains of microorganisms and methods..., we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Bank of autochthonous strains of microorganisms and methods... will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-2954253