LACTOSPORE^Ò is a lactic acid bacillus preparation manufactured and distributed by the SABINSA CORPORATION. This booklet reviews the background, nutritional and therapeutic aspects and current status of the use of lactic acid bacillus preparations, and presents arguments for the superiority of LACTOSPORE^Ò over other such products in the market, known as "probiotics", used in microbiotherapy.

The foundations of probiotic (meaning "in favor of life") microbiotherapy lie in the postulate of Metchnikoff, a Russian physician, that the growth of toxin-producing putrefactive organisms in the gastrointestinal tract could be controlled by the implantation of beneficial lactobacilli in the gut. The clinical application of preparations containing lactobacilli was initiated on the basis of Metchnikoff’s THEORY OF LONGEVITY, which associates with prolonged youthfulness and a healthy old age with the continuous ingestion of lactobacilli. Metchnikoff attributed the longevity of the residents of the Balkan countries to the regular consumption of Bulgarian buttermilk 1. In the early 1900’s, he claimed to have successfully cured many of his patients who suffered from a wide variety of organic illnesses, ranging from dryness of skin and gastrointestinal disorders to atherosclerosis, through the therapeutic use of Lactobacilli. Metchnikoff suggested that aging is the process of chronic putrefactive intoxication caused by certain intestinal bacteria and that these harmful effects could be mitigated through regular ingestion of live Lactobacillus cultures - a postulate that created a sensation in those early days. The enthusiasm shown then by eminent doctors of that time, advocating the therapeutic use of Lactobacillus, laid the foundations of LACTOBACILLUS THERAPY or MICROBIOTHERAPY.

Fermented milks have been a part of the human diet since ancient times. Their efficacy in alleviating gastrointestinal disorders has been exploited in systems of traditional medicine the world over. Lactic acid bacteria, the indigenous microbial flora in fermented milks and natural inhabitants of the human gastrointestinal tract were thought to be responsible for the longevity of their hosts through their curative and prophylactic actions.

The role of lactic acid bacteria in gastrointestinal microecology has been the subject of extensive research. It is widely believed that these bacteria prevent the growth of putrefactive microorganisms responsible for ill health by competitive inhibition, the generation of a non-conducive acidic environment and/ or by the production of antibiotic-like substances (bacteriocins). Their metabolites may include B group vitamins. Their proteolytic, lipolytic and b-galactosidase activities improve the digestibility and assimilation of ingested nutrients, thereby rendering them valuable in convalescent/ geriatric nutrition and as adjuncts to antibiotic therapy. Lactic acid bacteria also colonize the skin and mucus membranes and play an important role in preventing bacterial and fungal infections of the skin and genito-urinary tract. Lactobacilli have a protective role against vaginal infections. They utilize glycogen in the vaginal epithelial cells to produce lactic acid which helps to maintain the pH of this environment between 4.0 and 4.5, which creates a non-conducive environment for the growth of pathogens like Candida albicans, Trichonomas vaginalis and some of the non-specific bacteria, which are responsible for vaginal infections.

An adverse balance among intestinal bacteria with marked reduction in lactic acid bacteria and increase in putrefactive pathogens in the fecal flora has been observed in conditions like food allergy and eczema. The beneficial role of lactic acid organisms in preserving intestinal integrity and health has been documented extensively. However, the nutritional and therapeutic value of these organisms is still controversial.

In recent years, there has been an increasing interest in the relationship between intestinal microflora and their effects on the health of the human host. The ecosystem of the human gastrointestinal tract is extremely complex, colonized by more than 500 species of bacteria. Although lactobacilli in general represent a smaller percentage of the intestinal flora, their metabolic functions make them important. On colonization of the germ-free gastrointestinal tract in the human infant, shortly after birth, with normal gut flora, 2.4% are lactobacilli2. The species of lactobacilli normally present include L. bifidus (Bifidobacterium bifidum), L. acidophilus , L. casei, L. fermentum, L. salivarius, L. brevis, L. leichmanii, L. plantarum and L. cellobiosus 3 About one third of the fecal dry weight consists of bacteria.

Populations at high risk for colon cancer have been found to harbor gut flora which efficiently metabolize steroids and hydrolyze glucuronides. A diet containing large amounts of viable lactobacilli significantly lowered these activities in such individuals 4. The normal fecal flora in humans include the following organisms5:

In the process of performing their metabolic activities in the human gastrointestinal tract, these microflora convert complex ingested food constituents into easily digestible forms, perform detoxification processes, and produce metabolites of nutritional and therapeutic significance to the host. A delicate balance exists in the symbiotic relationship between these microflora and the human host.

The composition of the intestinal microflora is constantly changing, being influenced by factors such as diet, emotional stress, age and treatment with antibiotics or other medications.

In general, lactobacilli are acid tolerant and can survive and proliferate at low pH in the stomach. An optimal "balance" in the gastrointestinal microbial population is associated with good health in humans. This balance between beneficial bacteria and potentially harmful bacteria is referred to as EUBIOSIS.

In view of the pressures of modern existence, the maintenance of a normal, healthy, balanced microbial population (EUBIOSIS) in the gastro-intestinal tract is a difficult task. Humans are often subjected to various stress conditions such as changes in food consumption patterns, vagaries of the weather, extensive travel and somatic diseases that necessitate treatment with antibiotics and immunosuppressive drugs. Under such adverse circumstances, the harmful bacteria may become predominant (a condition referred to as bacterial overgrowth) and create an imbalance which may in turn impair normal gut function and lead to various problems, ranging from inefficient digestion, diarrhea, constipation, and flatulence to severe gastro-intestinal disorders.

A logical approach to restoring the balance of intestinal flora is the use of probiotics. However, reports on the survival and effectiveness of these microorganisms in the gastrointestinal tract are controversial. Ingested as viable organisms, these microbes often do not survive the rigors of the gastric environment.

In order to provide the beneficial effects of lactic acid bacteria, many manufacturers have been marketing various lactobacillus preparations. The reported health effects of these preparations include effectiveness in the treatment of a variety of disorders including colitis, constipation, diarrhea, , flatulence, gastric acidity, gastroenteritis, gingivitis, hypercholesterolemia, hepatic encephalopathy and tumorigenesis, and in recolonization of the intestine with beneficial flora after treatment with antibiotics. However, the reports are controversial owing to the differences in viability of the implanted flora in the gastrointestinal tract. Successful implantation depends upon the following factors:

1. A high count of viable lactobacilli retaining their viability during manufacturing into dosage forms and subsequent storage.

2. Survival of lactobacilli, once ingested, in the acidic gastric secretions and their safe passage to the intestine.

3. The production of a sufficient quantity of metabolites antagonistic to pathogens. These include L (+) (dextrorotatory) lactic acid and bacteriocins.

Various species of lactobacilli have been examined including L. bulgaricus, L. bifidus, L. acidophilus , L. casei, L. brevis and S. thermophiles . L. acidophilus, long regarded as the best candidate for therapeutic use, has been shown to be ineffective in alleviating certain gastrointestinal disorders6. Besides, it produces D(-) (levorotatory) lactic acid, which is not an effective antagonistic agent and may introduce metabolic disturbances.

A superior and potential species among Lactobacillus is L. sporogenes and it is also named as Bacillus coagulans. This species forms spores, which on activation in the acidic environment of the stomach, can germinate and proliferate in the intestine, produce the favored L (+) form of lactic acid and effectively prevent the growth of pathogens. In effect, the process can be equated to the slow release of viable cells, leading to prolonged and effective beneficial microbial activity. L. sporogenes spores are slowly excreted out of the human system, long after the termination of therapy. In view of the fact that the World Health Organization (W.H.O.) has recommended restricted intake of D(-) lactic acid for adults and total avoidance of the use of this form of lactic acid in infant nutritional products8, L. sporogenes is the Lactobacillus favored in infant nutritional programs.

LACTOSPORE^Ò, a preparation containing viable spores of L. sporogenes, is a registered trade mark of SABINSA CORPORATION. L. sporogenes preparations in powder, tablet and capsule forms have been used in successful clinical trials in the treatment of gastrointestinal disorders, vaginal infections , hypercholesterolemia, lactose intolerance, hepatic coma and precoma and as an adjuvant to antibiotic therapy.

Some commercially available preparations are as follows: