Probiotic delivery systems

Abstract

Suppository compositions are provided combining a pharmaceutically acceptable matrix material that is solid outside of the human body and in a dry environment, but which melts at body temperature; and apple cider vinegar and one or more species of probiotic bacteria dispersed within the matrix material; wherein the matrix material contains a mixture of fatty acids that are solid at room temperature. Methods for supplementing and nourishing the microbiome of the rectum of a male or female and the microbiome of the vagina of a female are also disclosed. Oral dosage forms of the compositions of the present invention are also provided.

Description

BACKGROUND OF THE INVENTION[0001]Each human is a microbial laboratory, harboring an ecosystem of microbes whose numbers are greater than the total number of human cells in the body. In fact, for every one human cell there are approximately 10 microbial cells. The collective genome of the microbes living within each human is at least 150 times larger than the genome of the human that they inhabit.[0002]The first phase of the Human Microbiome Project, under the auspices of the National Institutes of Health, was completed in 2012. This multimillion-dollar research program was funded to catalogue and better define the microbes that inhabit the living human. Significant findings from this research include: 1) the microbiome is not the same among all humans, but varies dramatically from one individual to the next. 2) The microbiome of the individual also can change quickly over time, depending on the circumstances of the individual (diet, environment, drugs, etc.). 3) The largest number o...

AI Technical Summary

Benefits of technology

[0010]With regard to the rectal suppository, the intestines are a long, continuous tube running from the stomach to the anus. Most absorption of nutrients and water happen in the intestines. The intestines include the small intestine, large intestine, and rectum. The large intestine performs the vital functions of converting food into feces, absorbing essential vitamins produced by gut bacteria. Bacterial fermentation converts the chyme into feces and releases vitamins, including vitamins K, B1, B2, B6, B12, and biotin. Vitamin K is almost exclusively produced by the gut bacteria and is essential in the proper clotting of blood. Gases such as carbon dioxide and methane are also produced as a byproduct of bacterial fermentation and lead to flatulence, or gas passed through the anus. The digestive system, including the mouth, esophagus, stomach, small intestine and colon, make up one long tube that must act like the skin to protect the blood and inner organs against harmful materials. In fact, the lining of the digestive passageway is continuous with the skin at the mouth and anus, making the skin and the lining of the digestive passageway one continuous barrier that protects the blood and inner organs against harmful substances in the environment. There are data that suggest the microbiome in the rectal area of the gastrointestinal tract assists in maintaining a healthy immune system in both males and females, which the present invention accomplishes by inserting bacteria directly into the rectum.

Problems solved by technology

In fact, when the microbiota from obese humans or animals are transferred to healthy animals of average weight, but devoid of bacteria of their own, these recipient animals appear to have a greater risk of eventually becoming obese or diabetic.

However, one of the major issues is how to populate humans with a microbiome that may be able to support or restore health.

This is a medical issue that has been challenging.

1. Through food and drinks. Many products such as prebiotics and probiotics are currently marketed with this claim. Probiotics are found in foods such as certain yogurts and kefirs, while prebiotics are found in whole grains, bananas, onions, garlic, honey and artichokes. In addition, probiotics and prebiotics are added to some foods and available as dietary supplement. In addition, everyday foods such as miso, sauerkraut, pickles, kimchi, Kombucha tea and other fermented foods may contribute to promote a healthy intestinal microbiome.

2. Through capsules and tablets that are taken by mouth and contain these organisms known as probiotics. Some brands are available with live bacteria. Most commercial brands suggest they have a range of million to billions of bacteria strains because the delivery system breaks down so much of bacteria through the gastric acids in our stomachs. The amounts delivered are actually unknown. Each of the foregoing methods lacks the ability to directly deliver bacteria to the rectal area or the vaginal area. Studies have suggested that bacteria or probiotics may impact the function of colonizing microbes. Other studies suggest that supplementing bacteria via probiotics may promote homeostasis of the gut microbiota rather than change its composition. Each of the foregoing methods lacks the ability to directly deliver bacteria to the rectal area or the vaginal area. Studies have suggested that bacteria or probiotics may impact the function of colonizing microbes. Other studies suggest that supplementing bacteria via probiotics may promote homeostasis of the gut microbiota rather than change its composition.

3. Through fecal microbiota transplant (FMT), the process of transplantation of fecal bacteria matched from a healthy individual into an unhealthy recipient. FMT involves restoration of the colonic microflora by introducing healthy bacterial flora through infusion of donor stool, e.g. by enema, orogastric tube, by mouth, or by other implantation means, in the form of a capsule containing freeze-dried material, obtained from a healthy donor. Previous terms for the procedure include fecal bacteriotherapy, fecal transfusion, fecal transplant, stool transplant, fecal enema, and human probiotic infusion (HPI). Because the procedure involves the complete restoration of the entire fecal microbiota, not just a single agent or combination of agents, these terms have now been replaced by the new term fecal microbiota transplantation. However, current procedures at best provide stool samples with an approximate match for the microbiome needs of a patient.

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