Treatment for intestinal gas, bloating, microscopic colitis, inflammatory bowel disease and traveler's diarrhea using colloidal bismuth subcitrate

Abstract

A method of treatment for intestinal gas bloating, microscopic colitis, traveler's diarrhea and inflammatory bowel disease, said method comprising ingesting an effective quantity of a composition comprising colloidal bismuth subcitrate to eliminate gastrointestinal discomfort.

Description

CLAIM FOR PRIORITY / RELATED APPLICATIONS[0001]This application claims priority from U.S. Provisional Application Ser. No. 60 / 869,003 filed Dec. 7, 2006 entitled TREATMENT FOR INTESTINAL GAS, BLOATING, MICROSCOPIC COLITIS, INFLAMMATORY BOWEL DISEASE AND TRAVELERS DIARRHEA USING COLLOIDAL BISMUTH SUBCITRATE, which application is hereby incorporated by reference in its entirety.FIELD OF THE INVENTION[0002]The invention is directed to compositions and methods for the treatment of intestinal gas and other gastrointestinal disorders. More particularly, the invention relates to methods and compositions for treating intestinal gas, bloating, microscopic colitis, inflammatory bowel disease and traveler's diarrhea using colloidal bismuth subcitrate (CBS).BACKGROUND OF THE INVENTION[0003]Gas production normally occurs in the human colon, also known as the large intestine. Colonic gas production takes place when bacteria residing normally in the colon metabolize undigested or partially digested ...

AI Technical Summary

Benefits of technology

[0017]The invention involves the oral administration of colloidal bismuth subcitrate (CBS), and other forms and alterations of bismuth citrate. Reference to CBS or colloidal bismuth subcitrate should be understood to include ranitidine bismuth citrate and other forms and alterations of bismuth citrate. CBS has many advantages over the currently available bismuth subsalicylate because of decreased side effects and better tolerability of the medications at the doses required to treat appropriate conditions. The compounds according to the present invention may also be used for individuals that are allergic to aspirin. These substances may be used for the treatment of excessive gas production. These compounds may also be used for the prevention and treatment of traveler's diarrhea. These compounds may also be used to reduce the symptoms of microscopic colitis and to induce remission of this condition. Additionally, these compounds may be used for the medical management of abdominal bloating and diarrhea associated with functional bowel disorders such as irritable bowel syndrome. These compounds may also be used as adjunctive initial or maintenance therapy for IBD.

Problems solved by technology

These individuals are prone to the production of large volumes of intestinal gas.

Excessive intestinal gas results in the symptoms of excessive flatus, bloating, diarrhea and abdominal distension.

Patients with irritable bowel syndrome and other functional gastrointestinal disorders frequently complain of abdominal bloating, cramping and flatulence.

However, clinical studies have generally failed to demonstrate excessive gas production in these individuals.

Elderly patients with decreased digestive function, persons with lactose or fructose intolerance and many other patients commonly complain of excessive gas.

If diminished anal sphincter function is present, (as occurs in the elderly as well as persons with prior anal sphincter injury or surgery), excessive gas production may result in gas incontinence, an embarrassing condition that may result in diminished quality of life.

At present, patients with difficulty with excessive gas production, abdominal bloating or control of colonic gas have few readily available treatment options.

Unfortunately, this proposed mechanism has not been proven to be beneficial to patients.

Additionally, it may be hypothesized that easier passage of large gas bubbles may result in adverse effects of simethicone in patients with excessive intestinal gas production or those with gas incontinence.

Patients that are lactase deficient will incompletely absorb milk products when they ingest dietary substances that contain dairy.

Although some clinical trials have demonstrated benefits of activated charcoal in reducing gas passage, other studies have failed to demonstrate this positive effect.

Activated charcoal ingestion may also predispose to vitamin deficiencies and malabsorption of drugs.

Although laboratory studies have demonstrated that bismuth subsalicylate may decrease overall bacterial production of noxious gases such as hydrogen sulfite, no clinical studies have demonstrated effectiveness of this compound for the treatment or prevention of excessive intestinal gas.

No formal studies of bismuth citrate have been performed to determine its efficacy in the treatment of excessive gas or abdominal bloating.

Most clinicians are unable to duplicate the success rates of these studies in treating the symptoms and eradicating microscopic colitis due to patient's inability to tolerate these doses of bismuth subsalicylate.

Unfortunately, this dose will not be tolerated by a significant number of individuals using bismuth subsalicylate to prevent traveler's diarrhea, particularly if the common and unpleasant side effects of these doses of bismuth subsalicylate develop during travel.

The short and long term use of antibiotics in these conditions can be problematic.

Antibiotics may cause diarrhea, thus worsening these conditions.

Additionally, these drugs may wipe out beneficial bacteria and cause overgrowth of resistant organisms.

Long term use of metronidazole may result in injury to the nerves of the hands and feet.