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
2000-07-31
2004-02-24
Marx, Irene (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,...
C424S093450, C424S093440, C424S093400, C435S042000, C435S252900, C435S253400
Reexamination Certificate
active
06696057
ABSTRACT:
BACKGROUND
1. Field of the Invention
The present invention relates to the field of treatment of gastrointestinal disorders, hyperlipidemia and autoimmune diseases. More particularly, the present invention relates to a probiotic composition having lactic acid bacteria of the genius/species
lactobacillus bulgaricus
and
streptococcus thermophilus
, and a method of treatment using the same.
2. Background of the Invention
Gastrointestinal disease includes many disorders, including but not limited to, inflammatory bowel diseases such as ulcerative colitis and Crohn's disease, infectious enteritis (viral, bacterial, parasitic), antibiotic associative diarrhea,
clostridium difficile
colitis, microscopic or lymphocytic colitis, collagenous colitis, colon polyps and familial polyp syndromes (e.g., familial polyposis syndrome, Gardner's Syndrome),
helicobacter pylori
, irritable bowel syndrome, nonspecific diarrheal illnesses, and intestinal cancers.
The cause of many of these diseases is unknown. Such is the case with inflammatory bowel disease (“IBD”), the general term for diseases that cause inflammation in the intestines. For example, ulcerative colitis (“UC”) is an IBD that causes inflammation of the mucosa lining of the large intestine. The inflammation usually occurs in the rectum and lower part of the colon, but it may affect the entire colon.
The most common symptoms of UC include abdominal pain, tenesmus, fecal urgency, and bloody diarrhea. A person with UC may also experience fatigue, weight loss, loss of appetite, rectal bleeding, and loss of body fluids and electrolytes. Although UC is generally not itself fatal, a more severe form of the disease may lead to the formation of toxic megacolon leading to bowel perforations or bowel obstruction. UC may also increase the risk of colon cancer depending on the duration, extent and severity of the disease.
Despite the prevalence of IBD, including UC and Crohn's disease, no theories regarding the cause have yet been proven. In fact, as stated in U.S. Pat. No. 5,932,214, even the broader category of diseases known as IBD have “no cure, and exact causes of IBD are not yet understood.” (Col. 1, lines 40-41). Yet, advances in UC have shown, however, that it is possible to control the inflammation without knowing the etiology of the disease. Present methods of treatment for UC depend upon the extent of the disease and the severity of the symptoms. To distinguish the amount of colonic surface involved in the inflammation process, UC is divided into subgroups, including ulcerative proctitis, proctosigmoiditis, left sided UC and pancolitis. The locations of each of these subgroups of UC are illustrated in FIG.
1
.
Present treatments for gastrointestinal disorders, in general, and for UC specifically, rely on drug therapy and, where such drug therapy is not effective, surgery is required. For example, initial treatment for mild to moderate UC may include the 5-ASA agents, including sulfasalazine, oral or rectal mesalamine, or olsalazine as well as conventional corticosteroid enemas. Another treatment for UC is disclosed in U.S. Pat. No. 5,932,214. This method of treatment involves administration of an antibody, polypeptide or other molecule recognizing VLA-4 (very late antigen-4). Patients with persistent mild to moderate symptoms of active UC, in spite of these therapies (treatment refractory), may require conventional corticosteroids orally. Patients with still persistent symptoms or those with severe UC may require immunosuppressive agents such as azathioprine or 6-MP. Cyclosporin may be considered for those who do not respond. If conventional treatment is successful, remission is usually maintained with sulfasalazine and/or oral or rectal mesalamine or olsalazine, and, in some cases with azathioprine/6-MP.
Crohn's disease like UC is an inflammatory disease of the intestinal tract, but unlike UC, may involve any part of the GI tract, from mouth to anus. The terminal ilcum is a common site of involvement in active Crohn's disease and may result in malabsorption syndromes. Symptoms include diarrhea, abdominal pain, nausea, weight loss, and growth retardation. Active disease may lead to intestinal obstruction, bleeding, fistula formation, rectal abscesses, bowel perforation and peritonitis, and increased susceptibility to bowel cancer.
Treatment of Crohn's disease involves use of 5-aminosalycilic acids, corticosteroids, and immunosuppressive drugs. Antibiotics are necessary for infections and surgery may be required for refractory Crohn's or the complications that may develop from the disease. 5-ASA compounds may cause headache, nausea, fatigue, abdominal pain, worsening diarrhea, and in some cases, hypersensitivity reactions leading to rash, fever hepatitis, pneumonitis, hemolytic anemia, and bone marrow suppression.
Long term use of corticosteroids may cause Cushing's Syndrome hyperglycemia, acne, muscle weakness, osteoporosis, and cataract formation, among other things. Immunosuppressive agents may cause hepatic toxicity, bone marrow suppression, and pancreatitis among other things. Response to therapy is measured by improvement in clinical signs/symptoms of the disease along with improvement in disease activity on gastrointestinal imaging, using endoscopy and barium x-ray studies.
With respect to infectious enteritis, there are a variety of viruses, bacteria, and parasites that can infect the digestive tract and cause sudden and sometimes violent symptoms, including nausea/vomiting, diarrhea (sometimes bloody), abdominal pain and cramping, fever, weakness, and loss of appetite. Among the viral causes, most are due to the Rotaviruses and the enteric caliciviruses such as Norwalk virus. Among the bacterial causes, Salmonella, Shigella, and Camphylobacter are the most common, but other pathogens like pathogenic
E. Coli
, Vibrio, and Yersinia can occur in endemics both inside and outside the United States. Parasitic infection can be due to protozoal organisms like
Entamoeba histolytica
, Giardia, and Cryptosporidium.
Treatment of these infections include general supportive measures like bed rest, hydration, and nutritional support. Some require antibiotics or antiparasitic agents. These drugs can cause allergic reactions and can affect the normal bowel flora and cause superinfections with harmful bacteria like
Clostridium difficile
. Some may also effect other organ systems like the liver and kidneys. Clinical improvement can be monitored by the white blood count, and clearing of the offending pathogen on serial stool analysis.
Antimicrobial agents are responsible for 25% of drug induced diarrhea. The rates of antibiotic associated diarrhea (“AAD”) vary from 5 to 39% depending on the specific type of antibiotic used. The mechanism of AAD may be due to functional disturbance of intestinal carbohydrate or bile acid metabolism, an allergic or toxic effect on the intestinal mucosa, a pharmacologic effect on motility, or a disruption of the normal intestinal flora causing an overgrowth of harmful bacteria like
Clostridium difficile, Clostridium perfinges, Staphylococcus aureus, Klebsiella oxytoca
, Candida species, or Salmonella species. About 10 to 20% of all cases of AAD are caused by
Clostridium difficile
, an anaerobic bacteria that secretes 2 enterotoxins, A and B, which can induce a severe colitis of the intestinal lining. Symptoms, at one end of the spectrum include a mild diarrhea, which resolves after discontinuation of the antibiotic, to severe disease causing high fever, leukocytosis, abdominal pain, profuse diarrhea, hypoalbuminemia, dehydration, and electrolyte disturbances. In rarer cases, toxic megacolon with perforation and death may occur.
The impact of AAD is reflected by higher medical costs, increased hospital stays, and increased rates of comorbidities. Treatment involves discontinuing the antibiotic, general supportive measures, bed rest, hydration, electrolyte and nutritional support, and in some cases, treatment with other antibiotics like metronidazole and vancomycin, to
Gridley Doreen J.
Lacpro Industries, Inc.
Marx Irene
Miller Ice
Swift Michael A.
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