Probiotic lactic acid bacterium to treat bacterial infections associated with sids

Abstract

Compositions including a non-pathogenic lactic acid-producing bacteria, such as a Bacillus species, spores or an extracellular product of B. coagulans, formulated for oral administration to the intestinal tract for inhibiting bacterial gastrointestinal infections are described. Methods and systems using the compositions for treating gastrointestinal infections, particularly sudden infant death syndrome (SIDS) are also disclosed.

Description

RELATED APPLICATIONS[0001]This application is a continuation application of 09 / 424,527 filed May 29, 2003, pending, which is a national stage Application filed under 371 based on PCT / US98 / 11347 filed Jun. 3, 1998, which claims priority to provisional Application 60 / 048,452, filed Jun. 3, 1997.TECHNICAL FIELD[0002]This invention relates to utilizing a probiotic organism as a food additive or supplement, and specifically relates to use of Bacillus coagulans in food or as a food supplement to prevent Sudden Infant Death Syndrome (SIDS) associated with infant gut microbial infections.BACKGROUND OF THE INVENTION[0003]Probiotic agents are organisms that confer a benefit when they grow in a particular environment, often by inhibiting the growth of other biological organisms in the same environment. Examples of probiotics include bacteria and bacteriophages which can grow in the intestine, at least temporarily, to displace or destroy pathogens and provide other benefits to the host organism...

AI Technical Summary

Problems solved by technology

Since the discovery and widespread use of antibiotics in about 1950 to treat pathological microbes, the use of probiotics has been limited.

The widespread use of antimicrobial drugs, especially broad spectrum antibiotics, has produced serious consequences.

Individuals taking antibiotics often suffer from gastrointestinal upset when beneficial microorganisms in the gut are killed, thus changing the balance of the intestinal flora.

This imbalance can result in vitamin deficiencies when vitamin-producing gut bacteria are killed and additional illness if a pathogenic organism overgrows and replaces the beneficial gut microorganisms.

Microorganisms that are resistant to multiple drugs have also developed, often with multiple drug resistance spreading between species, leading to systemic infections that cannot be controlled by use of known antibiotics.

Although SIDS is a leading cause of infant mortality in the developed countries of the world, its cause is not well understood.

Moreover, intestinal injury may result in increased production of cytokines (e.g., interferon-gamma, tumor necrosis factor and interleukins) that exacerbate the effects of the toxins leading to a biochemical cascade that alters the circuits that control cardiorespiration, leading to irreversible shock and death (Lindsay J. A. et al., Curr. Microbiol. 27:51-59, 1993; Mach A. S. & Lindsay J. A., Curr. Microbiol. 28:261-267, 1994).

For example, toxin-induced changes in cell membrane permeability leading to abnormal levels of intracellular ions (potassium and / or calcium) in heart tissue may lead to cardiac failure.

Because SIDS occurs generally in young infants, before the immune system as fully developed, a vaccine against bacterial pathogens associated with SIDS would usually not be effective to prevent SIDS-associated infections because the infant would not produce a sufficient immune response to the immunogen.

Anti-toxin antibodies (e.g., as disclosed in U.S. Pat. No. 5,599,539) have limited efficacy because they do not limit growth of the toxin-producing bacteria which can continue to produce toxin and the antibodies may produce an allergic reaction when orally administered.

Moreover, because of their mode of action, probiotics do not produce antibiotic side effects or lead to drug-resistant pathogens.