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10/25/07 - USPTO Class 424 |  12 views | #20070248582 | Prev - Next | About this Page  424 rss/xml feed  monitor keywords

Lactic bacteria and their use in the prevention of diarrhea

USPTO Application #: 20070248582
Title: Lactic bacteria and their use in the prevention of diarrhea
Abstract: The present invention concerns a lactic composition useful for the prevention or treatment of diarrhea such as antibiotic associated diarrhea or “tourista”. The composition according to the invention contains at least a bacterial strain selected from the group consisting of Lactobacillus acidophilus, Lactobacillus acidophilus I-1492 Lactobacillus casei and a mixture of thereof. (end of abstract)



Agent: Godfrey & Kahn S.c. - Milwaukee, WI, US
Inventor: Francois-Marie Luquet
USPTO Applicaton #: 20070248582 - Class: 424093450 (USPTO)

Related Patent Categories: Drug, Bio-affecting And Body Treating Compositions, Whole Live Micro-organism, Cell, Or Virus Containing, Bacteria Or Actinomycetales, Lactobacillus Or Pediococcus Or Leuconostoc

Lactic bacteria and their use in the prevention of diarrhea description/claims


The Patent Description & Claims data below is from USPTO Patent Application 20070248582, Lactic bacteria and their use in the prevention of diarrhea.

Brief Patent Description - Full Patent Description - Patent Application Claims
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FIELD OF THE INVENTION

[0001] The present invention relates to the use of lactic bacteria strains in the prevention of diarrhea. More particularly, the present invention concerns the use of lactic bacteria in order to prevent antibiotic associated diarrhea (AAD).

DESCRIPTION OF PRIOR ART

[0002] Diarrhea may be caused by a temporary problem, like an infection, or a chronic problem, like an intestinal disease. A few of the more common causes of diarrhea are listed below: [0003] Bacterial infections: Several types of bacteria, consumed through contaminated food or water, can cause diarrhea such as Campylobacter, Salmonella, Shigella, and Escherichia coli. [0004] Viral infections: Many viruses cause diarrhea, including rotavirus, Norwalk virus, cytomegalovirus, herpes simplex virus, and viral hepatitis. [0005] Parasites. Parasites can enter the body through food or water and settle in the digestive system. Parasites that cause diarrhea include Giardia lamblia, Entamoeba histolytica, and Cryptosporidium. [0006] Reaction to medication, such as antibiotics, blood pressure medications, and antacids containing magnesium. [0007] Intestinal diseases like inflammatory bowel disease or celiac disease. [0008] Functional bowel disorders, such as irritable bowel syndrome, in which the intestines do not work normally.

[0009] About 10% of all antibiotic treatments are known to be responsible for gastrointestinal side-effects, notably diarrhea called antibiotic associated diarrhea (AAD).

[0010] All groups of antibiotics may cause AAD, but those with broad-spectrum coverage, such as cephalosporins, extended-coverage penicillins, and clindamycin, are the most common causes of AAD.

[0011] The incidence of AAD, from 5 to 39%, has been on the rise in the past years, particularly following the increased utilization of wide spectrum antibiotics (Bergogne-Berezin, 2000; McFarland, 1998; Spencer 1998). The clinical presentation of AAD is very variable, ranging from an uncomplicated diarrhea to a pseudomembranous colitis.

[0012] It should be noted that 10 to 20% of cases of AAD are caused by a Clostridium difficile (C. difficile) infection (Bergogne-Berezin, 2000; Bartlett, 2002). C. difficile is an anaerobic gram-positive rod. C. difficile diarrhea is largely a nosocomial disease and it is the most frequent cause of diarrhea in hospitalized patients. Its occurrence in the outpatient setting, other than in patients confined to nursing homes, is much less common.

[0013] C. difficile diarrhea is used to describe a wide spectrum of diarrheal illnesses caused by the potent toxins produced by this organism, including cases of severe colitis with or without the presence of pseudomembranes.

[0014] In particular this organism can be isolated in a great number of AAD cases with evidence of colitis and in all those with pseudomembranes. It is widely present in the environment and may survive for a considerable time. It is transmitted by the fecal-oral route to susceptible individuals. It is considered part of the normal flora of infants and can be isolated in about 5% of healthy adults and in up to one third of asymptomatic or colonized, hospitalized patients.

[0015] Both C. difficile toxins A and B exhibit potent enterotoxin and cytotoxic effects that are responsible for the clinical manifestations.

[0016] AAD, and more particularly C. difficile AAD, may subsequently bring about important consequences at the financial level as well as at the clinical level: increase of the morbidity, of the mortality, of the number of hospitalization as well as the duration of these (McFarland, 2002). It is observed that the development of a C. difficile AAD presents a risk not only for the patient undergoing antibiotic therapy, but also for the other patients hospitalized in the same care unit, given the contagious character of this diarrhea (Bartlett, 2002).

[0017] Epidemiologic studies have shown that C. difficile is often isolated in hospital wards, including the floors, door handles, and furniture even weeks after patients with AAD have been removed from the area. Less frequently, similar observations have been made among asymptomatic medical personnel and in hospital wards occupied by unaffected patients. Patients readmitted after recent hospitalizations are found to have a high prevalence of C. difficile colonization, which represents an important source of infection. Because of the sporulating properties of this organism, all these observations suggest an important role for cross-contamination between patients, contact with environmental surfaces, and transmission via hands of medical personnel.

[0018] Many antimicrobials have been used to treat C. difficile colitis. The development of effective preventive measures against AAD thus seems unavoidable.

Lactic Acid Bacteria

[0019] It is the scientist E. Metchnikoff (1845-1919) who proposed that the longevity and the health of the Bulgarian people is attributable to their ingestion of fermented milk products. It was well known that certain bacteria are pathogenic to the organism. Thus, it was proposed that these bacteria be substituted by yogourt bacteria since the latter had long been used without fear. Many standard guidelines have been established in order to define a good lactic acid bacterium. Among these standards are: they must conserve their activity and their viability prior to consumption, they must survive the gastro-intestinal tract, they must be able to survive and to proliferate in the intestines, and must eventually produce beneficial effects. In addition, the micro-organisms must not be pathological nor toxic.

[0020] Many trials have been conducted in order to improve the state of health by modifying the intestinal flora through living lactic acid bacteria. Today, the beneficial effects of these lactic acid bacteria are well identified and there are attempts to explain the mechanism(s) related to such benefits. Salminen's team has summarized the most important beneficial effects, supported by scientific evidence such as immunological modulation and reinforcement of the intestinal mucous barrier. Different mechanisms are proposed in order to explain to what such benefits would be due: the modification of the intestinal flora, adherence to the intestinal mucous membrane with the capacity of preventing the adherence of pathogenic bacteria or the activation of pathogens, the modification of food proteins by intestinal microflora, the modification of bacterial enzymatic capacity, and finally the influence on the permeability of intestinal mucosa.

[0021] Many studies indicate a therapeutic potential of lactic acid bacteria and yogurt which is mainly due to the change in gastro-intestinal micro-ecology. The efficiency of lactic acid bacteria is enhanced by their capacity of adherence to the intestinal wall since the adherent bacterial strains have a competitive advantage, important to maintain their place in the gastro-intestinal tract. On the other hand, no bacterial strain has yet been shown to adhere in a permanent fashion. By increasing the quantity of lactic acid bacteria in the intestines, it is possible to eliminate growth of pathogenic bacteria, which in turn will contribute to a reduction of infections. An intact intestinal epithelium with an optimal intestinal flora represents a barrier against invasions or colonization by pathogenic micro-organisms, antigens and harmful compounds for the intestinal tract.

[0022] In general, the consumption of lactic acid bacteria acts by a reinforcement of the non-specific immune response or acts as an adjuvant in the antigen-specific immune response. Studies on animals have demonstrated that the lymphoid tissue associated to the intestines is stimulated by living lactic acid bacteria, resulting in a production of cytokines and antibodies (IgA) and an increase of mitogenic activity of the cells forming Peyer plaques and splenocytes. In the studies on human cells, the production of cytokine, phagocytic activity, antibody production, the function of T cells and NK cell activity are increased by the consumption of yogurt or when the cells are exposed to lactic acid bacteria in vitro.

[0023] Evidence exists that the yogurt stimulation of the immune system may be associated with the reduction of pathological incidences like cancer, gastro-intestinal disorders and allergy symptoms.

[0024] Lactic acid bacteria are also known as probiotics. The term "probiotic" describes dietary supplements composed of living micro-organisms destined to enhance health (D'Souza et al., 2002). The most frequently species used are Lactobacillus spp., Bifidobaterium spp. and Saccharomyces spp. (Cremonini et al., 2002; Lu et al., 2001; Lewis et al., 1998; D'Souza et al., 2002; Isolauri, 2001). Many mechanisms of action have been proposed to explain their efficacy, such as the production of antimicrobial substances, the competition for gastro-intestinal colonization as well as for available nutrients, immunomodulation and the promotion of lactose digestion (Lu et al., 2001; D'Souza et al., 2002; Alvarez-Olmos et al., 2001).

[0025] Many studies, both in vitro and in vivo, have demonstrated that Lactobacilli (in particular, L. acidophilus) are not just normal inhabitants of the intestinal tract. Lactobacilli also play an important role in stimulating the immune system, inhibiting pathogens and lowering colon cancer risks.

[0026] Moreover, the effects of probiotics on general health are numerous. Probiotics are known to enhance intestinal health, improve digestion, strengthen the immune system, reduce blood cholesterol and reduce the HDL/LDL ratio. Probiotics have also been tried in AAD.

[0027] Several researchers have concluded that probiotics are effective in the treatment of acute infectious diarrhea in children and in the prevention of AAD and nosocomial/community acquired diarrhea (Gill and Garner, 2004). In a meta-analysis of over 20 studies, Cornelius et al. (2004) suggested that Lactobacillus is a safe and effective treatment of acute diarrhea in children. Moreover, it has been shown that a child-care formula supplemented with Lactobacillus reuteri or Bifidobacterium lactis reduced the episodes and duration of diarrhea in infants (Weizman et al. 2005). U.S. Pat. No. 6,887,465 to Reniero et al., discloses the use of Lactobacillus strains for preventing diarrhea caused by pathogenic bacteria and rotaviruses in children from 35 to 70 months old.

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