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Title:  Composition and method for treatment of gastrointestinal disorders and hyperlipidemia

United States Patent:  6,696,057

Issued:  February 24, 2004

Inventors:  Bojrab; Gregory G. (Indianapolis, IN)

Assignee:  Lacpro Industries, Inc. (Indianapolis, IN)

Appl. No.:  629578

Filed:  July 31, 2000

Abstract

A probiotic composition and method for the treatment of gastrointestinal disorders, hyperlipidemia and autoimmune diseases. The probiotic composition comprises a culture having lactobacillus bulgaricus and streptococcus thermophilus lactic acid bacteria and a carbohydrate enriched media, whereby the culture and media are combined and allowed to ferment until a desired ratio of the lactobacillus bulgaricus and streptococcus thermophilus organisms as well as a desired number of total organisms per dose are achieved. The method of the present invention comprises the steps of providing a probiotic composition of the present invention and administering the composition to a patient having at least one of gastrointestinal disorders, hyperlipidemia or autoimmune diseases.

SUMMARY OF THE INVENTION

In accordance with the present invention, a probiotic composition and method for the treatment of gastrointestinal disorders, hyperlipidemia and autoimmune diseases is provided that solves the deficiencies inherent in traditional treatments of gastrointestinal diseases, hyperlipidemia and autoimmune diseases. The present invention provides an effective treatment for gastrointestinal disorders, hyperlipidemia and autoimmune diseases that avoids adverse side effects, is reasonable in cost for the patient, and may be beneficial in reducing the risk of colon cancer. Further, the present invention is relatively easy to manufacture and deliver to the patient.

In accordance with the present invention, a probiotic composition for the treatment of gastrointestinal disorders, hyperlipidemia and autoimmune diseases is provided. The probiotic composition comprises a mixture having lactobacillus bulgaricus and streptococcus thermophilus lactic acid bacteria. The probiotic composition further comprises a carbohydrate enriched media whereby the mixture and media are combined and allowed to ferment until a desired ratio of the lactobacillus bulgaricus and streptococcus thermophilus organisms as well as a desired number of total organisms per dose are achieved. The desired ratio of lactobacillus bulgaricus and streptococcus thermophilus organisms ranges from about 1:1 to 10:1. The desired number of total organisms per dose ranges from about 1x106 to about 2x1012.

The present invention further includes a method for treating gastrointestinal disorders, hyperlipidemia and autoimmune diseases using a probiotic composition. The method comprises the steps of providing a probiotic composition comprising a mixture of lactobacillus bulgaricus and streptococcus thermophilus lactic acid bacteria. The composition further comprises a carbohydrate enriched media where the mixture and the media are combined and allowed to ferment until a desired ratio of lactobacillus bulgaricus and streptococcus thermophilus organisms as well as a desired number of total organisms per dose are achieved. Next, the probiotic composition is administered to a patient.

DETAILED DESCRIPTION OF THE INVENTION

In accordance with the present invention, a probiotic composition for the treatment of gastrointestinal disorders, hyperlipidemia and autoimmune diseases is provided. The probiotic composition comprises a mixture. The mixture comprises lactobacillus bulgaricus and streptococcus thermophilus lactic acid bacteria. The mixture may be in the form of a culture. The probiotic composition further includes a carbohydrate enriched media whereby the mixture and media are combined and allowed to ferment until a desired ratio of the lactobacillus bulgaricus and streptococcus thermophilus organisms, as well as a desired number of total organisms per dose are achieved. The probiotic composition's desired ratio of lactobacillus bulgaricus and streptococcus thermophilus organisms range from 1:1 to about 10:1. One particular embodiment of the present invention includes a desired ratio of lactobacillus bulgaricus to streptococcus thermophilus organisms of about 9:1.

The present invention's desired number of total organisms per dose range from about 1x106 to about 2x1012. One embodiment of the present invention includes the desired number of total organisms per dose of about 5x1010.

The carbohydrate enriched media includes any such media as is common in the art. One embodiment of the present invention includes a carbohydrate enriched media that is a dairy product. Any dairy product may be appropriate, but milk is particularly useful as the media.

The probiotic composition can take the final form of either a liquid, solid, or semi-solid. For example, the probiotic composition may be a set or creamy yogurt. The probiotic composition may also be lyophilized and separated into specific dosing units. The dosing units may be packaged in one of several forms including but not limited to packets, capsules, tablets, or caplets. Any other packaging form as is common in the art may be utilized.

The present invention also includes a method for treating gastrointestinal disorders, hyperlipidemia and autoimmune diseases using a probiotic composition of the present invention. The method comprises the steps of providing a probiotic composition, the probiotic composition comprising a mixture, the mixture comprising lactobacillus bulgaricus and streptococcus thermophilus lactic acid bacteria. The composition further comprises a carbohydrate enriched media whereby the mixture and media are combined and allowed to ferment until a desired ratio of the lactobacillus bulgaricus and streptococcus thermophilus organisms, as well as a desired number of total organisms per dose are achieved. The method further comprises administering the probiotic composition to a patient.

The method of the present invention further comprises selecting a dosing form of the probiotic composition and determining an initial dosing strength and initial dosing frequency. The effectiveness of the probiotic composition in treating the patient is also determined. Adjusting both the dosing strength and the dosing frequency may be required to effectuate positive results in the patient. The efficacy of the probiotic composition is determined by at least one option chosen from evaluating the improvement of the patient's clinical symptoms, or evaluating medically standard objective parameters as appropriate for a particular disorder. Such medically standard objective parameters include, but are not limited to, gastrointestinal imaging using, for example, endoscopy and barium x-ray studies, biopsy, histopathology, restoration of fluid and electrolyte balance, normalization of white blood count, serial stool analysis, and checking fasting plasma LDL, HDL and triglycerides.

The probiotic composition may be prepared by combining a starter culture in a carbohydrate enriched media. The starter culture comprises lactobacillus bulgaricus and streptococcus thermophilus lactic acid bacteria. The combination of starter culture and media is allowed to ferment. During the fermenting process, temperature and pH of the combination is monitored and controlled as is well known in the art. The fermentation process is halted upon achieving a desired ratio of lactobacillus bulgaricus to streptococcus thermophilus organisms and a desired number of total organisms per dose. The probiotic composition may be packaged for delivery in this post-fermentation state. Alternatively, the probiotic composition may be concentrated after fermentation is complete and then lyophilized prior to packaging. Prior to concentrating and lyophilizing the probiotic composition, the fermented end product can be packaged as a yogurt as is typical in the art. After concentrating and lyophilizing, the probiotic composition can be packaged into desired dosing units. The packaged dosing units may be in any suitable form as is common in the art and can include, but not be limited to packets, capsules, caplets, or tablets.

One embodiment of the present invention has been used to successfully treat a 42 year old male with severe distal ulcerative colitis. The patient had been previously unresponsive to three different 5-ASA products including Rowasa, sulfasalazine, and olsalazine. Even though an initial response was achieved with rectally administered corticosteroids, relapses continued to occur when repeated attempts were made to taper therapy. Moreover, over-the-counter probiotics were tried, both in a commercial yogurt form and in a tablet form, but were not successful in treating the patient's disease.

However, a dramatic and immediate result was achieved when the present invention was used to treat the patient's distal ulcerative colitis. The probiotic composition of the present invention was administered orally twice daily. Each dose contained approximately 5.4x1010 organisms. The probiotic composition contained lactobacillus bulgaricus and streptococcus thermophilus in a ratio of 9:1. As of July 2000, the patient remains in clinical, endoscopic, and histologic remission. The patient has been off all other medications since starting therapy utilizing the probiotic composition of the present invention. The probiotic composition of the present invention remains well tolerated and has proven by far to be a preferred treatment over conventional therapy, both in composition and in delivery method.

As can be readily seen, the present invention eliminates the deficiencies associated with traditional compositions and methods of treating gastrointestinal diseases, hyperlipidemia and autoimmune diseases. The significant benefits of the present invention include effective treatment of the gastrointestinal diseases, hyperlipidemia and autoimmune diseases, as well as an avoidance of traditional side effects associated with current treatments. Further, due in large part to the relatively simple manufacturing processes and inexpensive raw materials, the present invention is much less costly to the patient than traditional approaches to treatment of gastrointestinal and autoimmune diseases and hyperlipidemia. Although other advantages may be found and realized and various modifications may be suggested by those skilled in the art, it is understood that the present invention is not to be limited to the details given above, but rather may be modified within the scope of the appended claims.

Claim 1 of 8 Claims

I claim:

1. A fermented probiotic composition for the treatment of gastrointestinal disorders, and hyperlipidemia, the composition comprising:

a.) a mixture of Lactobacillus bulgaricus and Streptococcus thermophilus lactic acid bacteria; and

b.) a carbohydrate containing media, the fermented probiotic composition comprising Lactobacillus bulgaricus bacteria and Streptococcus thermophilus bacteria in a ratio of about 9:1 and the number of Lactobacillus bulgaricus bacteria per dose is about 5x1010.




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