Methods and Compositions for Treating Lactose Intolerance

Abstract

The invention provides methods and compostions for treating lactose intolerance. In embodiments, the invention provides methods and composition for decreasing symptoms of lactose intolerance by administering to an individual suffering from lactose intolerance increasing doses of lactose using a protocol such that at the end of treatment the individual's symptoms of lactose intolerance are decrease and such that symptoms remain decreased after a period of time.

Description

CROSS REFERENCE TO RELATED APPLICATION[0001]This application is a continuation-in-part of U.S. utility patent application Ser. No. 10 / 710,588, filed Jul. 22, 2004, which is incorporated herein by reference in its entirety.BACKGROUND OF THE INVENTION[0002]According to several sources, there are 30 to 50 million people in the world who are lactose intolerant. In the 1960's and 1970's, it was reported that 70% of the adults in the world had lactose intolerance. In 1995, it was reported that 75% of the adults in the world and 25% of the adults in the U.S. were categorized as being lactose intolerant. In 1994, it was reported that 75% of African Americans and Native Americans and 90% of Asian Americans had lactose intolerance. It has also been reported that 30% of adults who are mostly North Western and North American descendants of the Europeans, have adapted to high lactase activity into adulthood. Research concludes that this adaption is genetically controlled, permanent and related t...

AI Technical Summary

Benefits of technology

[0016]The use of lactase tablets help lactose intolerant people digest milk and milk products. Each lactase tablet typically hydrolyzes up to 99% of the ingested lactose within 24 hours, and is designed to be ingested with the lactose containing food.

[0035]Additional substances may be given in conjunction with lactose. These substances can enhance the action of the increasing doses of lactose by, e.g., encouraging the growth of bacteria in the gut that alleviate symptoms of lactose intolerance, increasing adhesion of friendly bacteria, or allowing doses of friendly bacteria to more readily pass through the stomach without being destroyed. These substances may be given prior to treatment with lactose, during treatment with lactose, after treatment with lactose, or any combination thereof. If administered during lactose treatment, they may be administered with the dose of lactose being given, or before or after the dose of lactose, or any combination thereof.

[0037]Live bacteria, e.g., live cultured bacteria, that may be used in the methods and compositions of the invention include any suitable bacteria for assisting in reduction or elimination of the symptoms of lactose intolerance. Typically such bacteria will be probiotic. Probiotic bacteria favorably alter the intestinal microflora balance, inhibit the growth of harmful bacteria, promote good digestion, boost immune function, and increase resistance to infection. People with flourishing intestinal colonies of beneficial bacteria are better equipped to fight the growth of disease-causing bacteria. Probiotic bacteria such as lactobacilli and bifidobacteria are thought to maintain a healthy balance of intestinal flora by producing organic compounds, such as lactic acid, hydrogen peroxide, and acetic acid, that increase the acidity of the intestine and inhibit the reproduction of many harmful bacteria. Probiotic bacteria also produce substances called bacteriocins, which act as natural antibiotics to kill undesirable microorganisms. Nonexclusive examples of probiotic bacteria that may be used in the methods of the invention include L. acidophilus or lactobacillus acidophilus. Acidophilus, a probiotic, is one of the most important strains of the Lactobacilli family of microflora which inhabit the gastrointestinal tract. These “good” bacteria are involved with immune system function, inhibiting carcinogenesis, metabolism of cholesterol, aging, and nutritional status. Acidophilus and other probiotic bacteria help maintain optimum pH, reduce putrefaction, and reduce endotoxemia. Other lactobacillus bacteria which may be employed include Lactobacillus crispatus, Lactobacillus casei, Lactobacillus rhamnosus, Lactobacillus reuteri, Lactobacillus fermentum, L. plantarum, L. sporogenes, L. bulgaricus and Lactobacillus rhamnosus. Other probiotic bacteria include Bifidobacterium lactis, B. bifidum, B. infantis, Saccharomyces boulardii. The bacteria may be given as part of a food, e.g., in yoghurt, or in powdered form. Mixtures of one or more species or strains of bacteria may be used.

[0040]Fructooligosacharides (FOS), are a non-digestible, soluble-fiber that supports the growth of beneficial bacteria in the intestinal tract, particularly two important strains—1. acidophilus and 1. bifidus. These two strains play an essential role in reducing the number of pathogenic bacteria. Additional nutritional properties, such as the effect on colonic pH and stool bulking justify their classification as dietary fibers. In experimental models, it has also been reported that they improve the bioavailability of essential minerals. As a fiber, it is thought to slow digestion and allow the painless reintroduction of lactose into the body. FOS are chain polymers of the sugar fructose that are found in a variety of foods. The sugar units can be linked in a single straight chain or can be a chain with side branches. In many cases small amounts of glucose are also contained in the chain. The length of the fructose chains can vary from source to source. Inulin is an example of a longer chained compound that is considered a FOS. The shorter (lower molecular weight) compounds tend to have a sweet taste. The size and complexity of the FOS molecule gives it desirable characteristics. Although the simple sugars fructose and glucose are quickly absorbed into the body by the intestines, FOS for the most part is indigestible and therefore acts as a non-digestible fiber in the diet. This is because the human does not have the enzymes to break down the FOS as it travels down the digestive tract. When the FOS reaches the large intestine and the colon, the bacteria that are found there start to break down the FOS. These bacteria have the enzymes needed to break down FOS. Bifido bacteria have been reported to use FOS. It is believed that foods that promote bifido bacteria growth are good for the health.

[0043]One or more buffers, optionally with a calcium counterion, may also be administered in methods of the invention. Any buffer suitable for consumption by the individual being treated, e.g., human, may be used. The buffer neutralizes stomach acidity which can, e.g., allow live bacteria to reach the gut. Buffers include citrates, phosphates, and the like. Some embodiments of the invention utilize a buffer with a calcium counterion, such as Calcium Phosphate Tribasic. The calcium can serve to restore the calcium that many lactose intolerant individuals are missing in their diet. A recent study demonstrated the ability of calcium phosphate to protect lactobacillus acidophilus from bile. It is an excellent buffering agent and will help neutralize stomach acidity.

[0063]The invention also provides compositions for the treatment of the symptoms of lactose intolerance. The compositions contain lactose and one or more of: bacteria, FOS, and / or buffer. Additional ingredients include ingredients to improve handling, preservatives, flavorings and the like.

Problems solved by technology

If an individual suspects that he has lactose intolerance, it is potentially harmful for him to restrict his diet since it may result in a nutrition shortage or a failure to detect a more serious disease.

The fermentation of the lactose in the large intestine produces hydrogen and methane which can lead to bloating, gas, and diarrhea.

For young children, the breath test is not as accurate because they usually have a tendency to get dehydrated which can cause diarrhea.