Drug – bio-affecting and body treating compositions – Whole live micro-organism – cell – or virus containing – Bacteria or actinomycetales
Reexamination Certificate
1998-12-30
2001-12-11
Witz, Jean C. (Department: 1651)
Drug, bio-affecting and body treating compositions
Whole live micro-organism, cell, or virus containing
Bacteria or actinomycetales
C424S093300
Reexamination Certificate
active
06328959
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Related Applications
This work is an extension of work previously described in U.S. Pat. No. 5,630,410, in which H
2
-metabolizing microbes were introduced into the intestines of rats breathing H
2
in a hyperbaric chamber. The purpose of the previous invention was to remove some of the H
2
dissolved in the tissues of the rats in order to reduce their risk of decompression sickness following the exposure to an atmosphere containing high pressures of H
2
. The compositions of this invention are related to the compositions of co-pending application Ser. No. 08/852,207, which application, in turn, is a division of U.S. Pat. No. 5,630,410.
2. Field of the Invention
This invention relates to a method for relieving abdominal pains under normal atmospheric conditions caused by hydrogen (H
2
) gas trapped in the large intestine. More particularly, this invention relates to a process of treating symptoms of irritable bowel syndrome or spastic colon or excessive flatulence or other gastrointestinal distress by assisting in the removal of H
2
trapped in the large intestine. This assistance is accomplished by supplying the intestine with an artificial excess amount of microbes that metabolize H
2
, converting some of the H
2
to water and other substances. This product and method supplement and accelerate the removal of H
2
from the large intestine that occurs spontaneously with normal intestinal microbial fermentation and motility, thereby relieving the symptoms of the disease.
3. Description of the Prior Art
Previously, one of the inventors developed and patented a method of “Accelerated Gas Removal From Divers' Tissue Utilizing Gas Metabolizing Bacteria”, U.S. Pat. No. 5,630,410. From this research, the inventors developed the concept of adapting the process to medical treatments for the symptoms of diseases or conditions that cause an excess of hydrogen (H
2
) in the large intestine or bowel.
As stated in Harrison's “Principles of Internal Medicine” Twelfth Edition, Volume I at page 259 (1991), flatulence is a normal occurrence in humans and in animals. In humans, it is often caused by the fermentation in the gut of indigestible polysaccharides and oligosaccharides of food humans eat. Patents such as U.S. Pat. No. 4,376,128 and 5,773,427 sought to defeat flatulence by enzyme treatments either before or after consumption. Others have proposed different combinations of bacteria to re-establish normal gut flora. Chaleil et al. (Ann. Pharm. Fr. 46(2): 133-137, 1988) addressed the subject of a potential link between
Methanobrevibacter smithii
and encephalopathy, and concluded that this link was not present. They were concerned that bismuth salts given to patients as a pharmacological agent could place these patients in jeopardy of encephalopathy if
M. smithii
in the intestinal flora allowed a retention and concentration of bismuth within the patient's brain and other tissues. The work of Chaleil et al. is not relevant to the use of
M. smithii
described by us for the removal of H
2
from the intestines of people suffering from Irritable Bowel Syndrome, nor is the instant invention relevant to encephalopathy or bismuth metabolism by
M. smithii.
The only link between this work and that of Chaleil et al. is the coincidental interest in
M. smithii
as a normal constituent of the human intestinal flora. The intent of this prior art is to re-establish normal flora concentration.
Brody (U.S. Pat. No. 5,443,826, 1995) relates to the removal of a significant quantity of the intestinal flora of patients suffering from complications induced by an abnormal, pathogenic flora. Brody then proposes to replace the abnormal flora with cultures of normal flora in their usual relative concentrations, to reestablish intestinal normalcy and promote general patient health. The instant invention differs from that of Brody by adding a significant surplus of only one microbial constituent of the intestinal flora, for example
M. smithii.
The instant goal is not to establish a normal flora, but to establish an exceptional concentration of a single purpose flora for a purpose not anticipated by Brody or any others, namely to remove H
2
from the intestines of people suffering from excess intestinal production of H
2
and thereby relieve the symptoms. Brody's invention is not relevant to H
2
removal, nor does our invention call for the loss of any pathogenic intestinal flora. The only link between our work and that of Brody is the coincidental interest in
M. smithii
as a normal constituent of the human intestinal flora.
With irritable bowel syndrome, some people experience abdominal pains caused by gas trapped in the large intestine. In many cases, a large fraction of this gas is H
2
, which is generated in the large intestine as an end product of the metabolism by certain species of bacteria. These bacteria are an established part of the intestinal flora of most people, but the amount of H
2
they make can vary widely among individuals, and between diets. Many people also harbor microbes that consume this H
2
to form several possible end products. The purpose of this invention is to treat the problem of excess intestinal H
2
by using a natural approach: by introducing more of the natural intestinal microbes that consume the H
2
.
In healthy humans with a healthy gut and diverse and nutritionally adequate diet, digestive enzymes in the mouth, stomach, or small intestine break down much of the food ingested, and the digested nutrients are absorbed. The healthy large intestine (colon) houses a large number of microbial species that metabolize the nutrients that are not fully absorbed higher in the digestive tract. Some microbes ferment the complex poly- and oligosaccharides for which humans have no digestive enzymes, for example the cellulose and hemicellulose of plant cell walls, the stachyose in beans and the trehalose in mushrooms. In some individuals, certain digestive enzymes are missing or defective and food products that are absorbed by most people in the small intestine reach the large intestine in unusually large quantities; lactase deficiency leading to colonic lactose fermentation is one example.
A complex community of different species of microbes accomplishes colonic fermentation. The microbes metabolize the material entering the large intestine to a variety of end products including water, acetic, propionic and butyric acids, and the gases H
2
and carbon dioxide (CO
2
). In some individuals and in ruminant animals, methane (CH
4
) is produced. Microbes that produce methane consume H
2
as part of the metabolic pathway. Accumulation of large quantities of H
2
in the colon occurs when the H
2
-producing microbes generate amounts of H
2
far in excess of the amounts that can be metabolized by the H
2
-consuming microbes. Normal mammalian physiological mechanisms cannot remove the excess H
2
rapidly enough through flatulence, causing excessive pressure.
Some people harbor large concentrations of a methane-producing organism,
Methanobrevibacter smithii.
It reduces carbon dioxide with H
2
to produce methane and water:
4H
2
+CO
2
→CH
4
+2H
2
O (Eq. 1)
This process uses four volumes of H
2
to produce one volume of methane and two volumes of water, and can significantly reduce the gas pressure caused by production of H
2
in the colon. About 20% of the colonic gas is absorbed through the intestinal wall, into the bloodstream, and expired in the breath. The rest of the gases exit the body as flatus.
In many people,
Methanobrevibacter smithii
concentrations in the colon are too low to account for significant consumption of H
2
. Instead of microbial species that produce methane (Eq. 1), these people harbor colonic microbes that use H
2
to reduce carbon dioxide to acetic acid (CH
3
COOH) and water.
4H
2
+2CO
2
→CH
3
COOH+2H
2
O (Eq. 2)
An example of a microbe that is common in mammalian colons and is capable of such a consumption of H
2
is Acetitomaculum spp. About 98% of the acetic and
Kayar Susan R.
Miller Terry L.
Wolin Meyer J.
Harris Charles H.
Hemby, Jr. Joseph K.
The United States of America as represented by the Secretary of
Witz Jean C.
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