Symbion™ and Immunological Management

The intestine is the largest immunological organ in the body, containing 70 to 80% of all the IgA producing immunological cells. Humans, like all warm-blooded animals, live in symbiotic association with a large, varied population of microorganisms in their gastrointestinal tract. This provides them with enhanced resistance to infectious diseases, through gastro-mucosal immunological control.

Under normal healthy conditions, the level of immunity is satisfactory. However, with stress, overuse of antibiotics and significant abnormal dietary changes, the natural healthy balance of microorganisms is disturbed and vulnerability to infection and auto immune illness occurs.

Dietary supplementation with live Lactic Acid microorganisms (probiotics), such as Symbion™, will repair and normalize an inbalance in the gastrointestinal tract. Probiotics stimulate an immune response and resistance to infections. (Perdigon , Fuller and Raya,2001).These reviewers state that the probiotic approach is attractive, because it is a re-constitution of the natural condition. It is a means of repairing a deficiency rather than the addition of foreign chemicals to the body, which may have toxic consequences or, as in the case of antibiotics, induce resistance and compromise subsequent therapy.

Reference: Gabriella Perdigon, Roy Fuller and Raul Raya, “Lactic Acid Bacteria and their Effect on the Immune System.” Intestinal Microbiology.2001.2(1):27-42.

Clin Microbiol Rev. 2003 October; 16(4): 658-672.

doi: 10.1128/CMR.16.4.658-672.2003.

Potential Uses of Probiotics in Clinical Practice

Gregor Reid,^1,2,3* Jana Jass,^1,2 M. Tom Sebulsky,² and John K. McCormick^1,2

Canadian Research and Development Centre for Probiotics, The Lawson Health Research Institute, London, Ontario N6A 4V2,¹ Departments of Microbiology and Immunology,² Surgery, University of Western Ontario, London, Ontario N6A 5C1, Canada³ *Corresponding author. Mailing address: Canadian Research and Development Centre for Probiotics, Lawson Health Research Institute, 268 Grosvenor Street, London, Ontario N6A 4V2, Canada.

Abstract

Probiotics are defined as live microorganisms that, when administered in adequate amounts, confer a health benefit on the host. There is now mounting evidence that selected probiotic strains can provide health benefits to their human hosts. Numerous clinical trials show that certain strains can improve the outcome of intestinal infections by reducing the duration of diarrhea. Further investigations have shown benefits in reducing the recurrence of urogenital infections in women, while promising studies in cancer and allergies require research into the mechanisms of activity for particular strains and better-designed trials. At present, only a small percentage of physicians either know of probiotics or understand their potential applicability to patient care. Thus, probiotics are not yet part of the clinical arsenal for prevention and treatment of disease or maintenance of health. The establishment of accepted standards and guidelines, proposed by the Food and Agriculture Organization of the United Nations and the World Health Organization, represents a key step in ensuring that reliable products with suitable, informative health claims become available. Based upon the evidence to date, future advances with single- and multiple-strain therapies are on the horizon for the management of a number of debilitating and even fatal conditions.

To read the entire publication, go to:
http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pmcentrez&artid=207122

The role of probiotic cultures in the control of gastrointestinal health

Rolfe RD. Department of Microbiology and Immunology, Texas Tech University Health Sciences Center, Lubbock 79430, USA. J Nutr 2000 Feb;130(2S Suppl):396S-402S

The use of probiotics to enhance intestinal health has been proposed for many years. Probiotics are traditionally defined as viable microorganisms that have a beneficial effect in the prevention and treatment of specific pathologic conditions when they are ingested. There is a relatively large volume of literature that supports the use of probiotics to prevent or treat intestinal disorders. However, the scientific basis of probiotic use has been firmly established only recently, and sound clinical studies have begun to be published. Currently, the best-studied probiotics are the lactic acid bacteria, particularly Lactobacillus sp. and Bifidobacterium sp. However, other organisms used as probiotics in humans include Escherichia coli, Streptococcus sp., Enterococcus sp., Bacteroides sp., Bacillus sp., Propionibacterium sp. and various fungi. Some probiotic preparations contain mixtures of more than one bacterial strain. Probiotics have been examined for their effectiveness in the prevention and treatment of a diverse spectrum of gastrointestinal disorders such as antibiotic-associated diarrhea (including Clostridium difficile-associated intestinal disease), infectious bacterial and viral diarrhea (including diarrhea caused by rotavirus, Shigella, Salmonella, enterotoxigenic E. coli, Vibrio cholerae and human immunodeficiency virus/acquired immunodeficiency disorder, enteral feeding diarrhea, Helicobacter pylori gastroenteritis, sucrase maltase deficiency, inflammatory bowel disease, irritable bowel syndrome, small bowel bacterial overgrowth and lactose intolerance. Probiotics have been found to inhibit intestinal bacterial enzymes involved in the synthesis of colonic carcinogens. There are many mechanisms by which probiotics enhance intestinal health, including stimulation of immunity, competition for limited nutrients, inhibition of epithelial and mucosal adherence, inhibition of epithelial invasion and production of antimicrobial substances. Probiotics represent an exciting prophylactic and therapeutic advance, although additional investigations must be undertaken before their role in intestinal health can be delineated clearly.

http://www.anapsid.org/probiotic2.html

Clinical Trials

A probiotic mixture alleviates symptoms in irritable bowel syndrome patients: a controlled 6-month intervention.

Kajander K , Poussa T, Farkkila M ,Korpela R Valio Ltd, Research Centre, Helsinki, Finland. Aliment Pharmacol Ther. 2005 Sep 1;22(5):387-94.

BACKGROUND: Irritable bowel syndrome is a gastrointestinal disorder of unknown aetiology. The effect of probiotics in this syndrome remains unclear. AIM: To investigate whether a probiotic mixture containing Lactobacillus rhamnosus GG, L. rhamnosus LC705, Bifidobacterium breve Bb99 and Propionibacterium freudenreichii ssp. shermanii JS is effective in alleviating irritable bowel syndrome symptoms. METHODS: A total of 103 patients fulfilling the Rome I or II criteria took part in this 6-month, randomized, double-blind placebo-controlled trial. The patients received a probiotic capsule or a placebo capsule daily. Gastrointestinal symptoms and bowel habits were recorded. RESULTS: At the end the total symptom score (abdominal pain + distension + flatulence + borborygmi) was 7.7 (95% CI: -13.9 to -1.6) points lower in the probiotic group (P = 0.015). This represents a median reduction of 42% in the symptom score of the probiotic group compared with 6% in the placebo group. In individual symptoms, borborygmi was milder in the probiotic group (P = 0.008), and for the rest of the symptoms there was a non-significant trend. CONCLUSIONS: The results indicate that this probiotic mixture is effective in alleviating irritable bowel syndrome symptoms. Considering the high prevalence of irritable bowel syndrome and the lack of effective therapies, even a slight reduction in symptoms could have positive public health consequences. PMID: 16128676 [PubMed — indexed for MEDLINE]

The Effects of Probiotics for Irritable Bowel Syndrome

Kim YG, Moon JT, Lee KM, Chon NR, Park H Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea. Korean J Gastroenterol 2006 Jun;47(6):413-9

BACKGROUND/AIMS: Irritable bowel syndrome (IBS) is a functional gastrointestinal (GI) tract disorder that has heterogeneous clinical presentations such as abdominal pain, diarrhea, constipation, and abdominal distension. It is known that several mechanisms are involved in the pathogenesis of IBS. Probiotics may target one or more pathophysiologic pathways in IBS and may improve the symptoms of IBS. However, the results of studies about probiotics on IBS are controversial. Therefore, the aim of this study was to evaluate the effect of probiotics on GI symptoms and intestinal gas volume changes in patients with IBS.

METHODS: Forty patients were randomly allocated to be treated with Medilac DS (Bacillus subtilis, Enterococcus faecium) (n=20) or placebo (n=20) in a double-blind, prospective manner. The change in intestinal gas volume and symptom scores after 4-week treatment were evaluated for the efficacy. RESULTS: There was no significant difference in bloating, frequency of gas expulsion, frequency of defecation, and hardness of stool before and after the treatment. However, the severity of abdominal pain and the frequency of abdominal pain decreased significantly in Medilac DS group (2.4+/-1.3 cm/day --> 1.6+/-1.6 cm/day, 1.7+/-1.3/day --> 1.0+/-1.0/day) (p=0.044, p=0.038), but not in placebo group (2.1+/-2.0 cm/day --> 1.8+/-2.1 cm/day, 1.3+/-1.2/day --> 1.4+/-1.9/day). In both groups, intestinal gas volume at baseline, after 2-week treatment, and after 4-week treatment did not show significant change. Medilac DS was well tolerated without adverse events.

CONCLUSIONS: Medilac DS is a safe and useful probiotic agent for the treatment of abdominal pain in patients with IBS.

PMID: 16809947 [PubMed — indexed for MEDLINE]

Gastro-intestinal and associated effects ( L. Sporogenes, a.k.a. Bacillus coagulans)

Reports from various hospitals that performed clinical trials on groups of patients suffering from a variety of intestinal disorders and allergic skin diseases are summarized in Table 5.1.It is evident that the administration of L. sporogenes markedly improved the general clinical condition of the subjects and provided relief from intestinal disorders and allergic skin conditions. Allergic skin conditions can be related to an imbalance of intestinal flora in the subject . This condition was therefore corrected by L. sporogenes therapy in these trials. Lactobacillus Sporogenes is currently known as Bacillus coagulans in the scientific community.

SUMMARY OF SELECTED CLINICAL REPORTS FROM JAPAN : TRIALS WITH LACBONÒ (L. Sporogenes).

1. Condition: Acute and chronic intestinal catarrh

• No. of subjects: 38
• Treatment: 100-600 million spores/ day in divided doses for 2-12 days
• Effectiveness rate: 86.8%
• Conclusion: Recovery from diarrhea to regular normal stools; general symptoms including anorexia improved

2. Condition: Diarrhea

• No. of subjects: 15
• Treatment: 75-600 million spores/ day in divided doses for 3-12 days
• Effectiveness rate: 100%
• Conclusion: Recovery from diarrhea to regular, normal stools from third to fourth day

3. Condition: Constipation

• No. of subjects: 10
• Treatment: 300-750 million spores / day in divided doses for 2-10 days
• Effectiveness rate: 70.0%
• Conclusion: Recovery to normal stools and disappearance of abdominal distention

4. Condition: Abnormal intestinal fermentation

• No. of subjects: 9
• Treatment: 300-600 million spores / day in divided doses for 3-14 days
• Effectiveness rate: 100.0%
• Conclusion: Vomiting and nausea disappeared; appetite improved; stools became normal and regular; diarrhea and stomach ache cured.

5. Condition: Dyspepsia infantum

• No. of subjects: 26
• Treatment: 100-200 million spores / day in divided doses for 1-7 days
• Effectiveness rate: 84.6%
• Conclusion: General conditions and nature of stools improved. Frequency of stools decreased to half or less than that before medication.

6. Condition: Allergic skin diseases

• No. of subjects: 5
• Treatment: 200-450 million spores / day in divided doses for 4-12 days
• Effectiveness rate: 80.0%
• Conclusion: Obvious eruptions of strophulus and eczema decreased from the third day (topical therapy employed concomitantly)

7. Condition: Miscellaneous symptoms

• No. of subjects: 10
• Treatment: 20-50 million spores / day in divided doses for 4-20 days
• Effectiveness rate: 80.0%
• Conclusion: Response seen in anorexia of nervous type and malnutrition in infants

The above data are cited from clinical reports by: Terumichi Kuniya, Pediatric Clinic of Shinko Hospital, Kobe; Jetsuo Nitta, Medical Clinic of Kugason Hospital; Goro Koide, Pediatric Clinic of Kanto Teishin Hospital; Michio Ogasawara, Medical Clinic of Kahoku Hospital; Susumu Nakazawa, Pediatric Clinic of Ebara Hospital.

Studies with SPORLAC (L. sporogenes ) in India. A total of 60 cases of neonatal diarrhea with watery stool frequency greater than 6 were examined for efficacy of SPORLAC treatment. Based on the suggested dosage level of SPORLAC at 5 million spores per kilogram body weight, each neonate was given a spore level of about 15 million spores per day. Some of the subjects had associated symptoms in addition to diarrhea

Most of the subjects (about 80%) had a history of breast-feeding. About 19% were both breast and bottle-fed and 1% were bottle-fed.The average duration for recovery was 1.8 days and the results of the study are tabulated:

As compared to the normal practice of administration of antibiotic and antidiarrheal mixtures, the complicating side effects were not seen in the series of SPORLAC trials. The average recovery time of 1.8 days helped to reduce dehydration in the subjects to a great extent.In a similar study in Japan(cited in 59) a comparable success rate of 78.4% with SPORLAC treatment for infantile diarrhea was obtained. An earlier study in India by Mathur et al. (cited in 59) found the average time for improvement in diarrheal conditions to be two to three days, with treatment.

Other Clinical Trial References:

Krivenko V.V., Potebnia G.P., Loiko V.V. ( 1989). Experience in treating digestive organ diseases with medicinal plants. Vrach Delo. March(3):76-8

Achterrah-Tuckermann U., Kunde R., Flaskamp E., Isaac O., Thiemer K. (1980). Pharmacological investigations with compounds of chamomile. 5. Investigations on the spasmolytic effect of compounds of chamomile and kamillosan on the isolated guinea-pig ileum. Planta Medica 39(1):38-50

Mann, C. and E.J. Staba. 1986. The Chemistry, Pharmacology, and Commercial Formulations of Chamomile. In L. E. Craker and J. E. Simon, eds. Herbs, Spices, and Medicinal Plants: Recent Advances in Botany, Horticulture, and Pharmacology. Vol. 1. Phoenix, AZ: Oryx Press. Pp. 235-280

Mariann S., Gizella V.P., Ede F. (1976). Antifungal effect of the biologically active components of Matricaria chamomilla L. Acta Pharm Hung. 46(5-6):232- 47

Choi E.M., Hwang J.K. (2004). Antiinflammatory, analgesic and antioxidant activities of the fruit of Foeniculum vulgare. Fitoterapia. 75(6):557-65.

Yamahara, et. al. 1990. Gastrointestinal Motility Enhancing Effect of Ginger and its Active Constituents. Chem. Pharm. Bull. 38(2):430-431.

Mustafa T., Srivastava K.C., Jensen K.B. (1993) .Drug development report: 9. Pharmacology of ginger, Zingiber officinale. Journal of Drug Development 6(1) : 25-39 Chevallier. A. The Encyclopedia of Medicinal Plants Dorling Kindersley. London 1996 ISBN 9-780751-303148

Baschetti, R., New Zealand Medical Journal, April 26, 156-157, 1995

Grigoleit H.G., Grigoleit P. (2005). Peppermint oil in irritable bowel syndrome. Phytomedicine12(8):601-6.

02/11/2006-

A combination of probiotics and prebiotics for newborns reduced the incidence of eczema by 34 percent in high-risk children, says a new study from Finland.

The research, published on-line ahead of print in the Journal of Allergy & Clinical Immunology (doi: 10.1016/j.jaci.2006.09.009), is said to be the first to link the prevalence of eczema to specific gut bacteria, and “thus supporting the important role of commensal bacteria in the pathogenesis of eczema.”

Eczema, also known as atopic dermatitis (AD), is one of the first signs of allergy during the early days of life and is said to be due to delayed development of the immune system. According to the American Academy of Dermatologists it affects between 10 to 20 percent of all infants, but almost half of these kids will ‘grow out’ of eczema between the ages of five and 15.

The research adds to a previous study from Finland that reported in 2003 that children who were exposed to the Lactobacillus rhamnosus GG (LGG) bacteria around the time of birth were 40 per cent less likely to develop atopic eczema at four years of age compared with children in a placebo group.

In the new study, Kaarina Kukkonen and colleagues from the University of Helsinki and Valio R&D built these earlier results by examining the effects of a probiotic and prebiotic combination on allergy prevention in a much larger population of allergy-prone infants than previously studied.

The researchers randomised 1223 pregnant women to receive either placebo or daily probiotic supplements containing four probiotic strains — Lactobacillus rhamnosus GG; L rhamnosus LC705; Bifidobacterium breve Bb99; and Propionibacterium freudenreichii ssp. shermanii JS.

The women were supplemented for the two to four weeks prior to delivery. The newborns were then supplemented with either the same probiotics in combination with galacto-oligosaccharides (461 babies) or placebo (464 babies) for six months.

Researchers have found that breast milk naturally contains prebiotic oligosaccharides, believed to stimulate bifidobacteria — so-called ‘friendly’ bacteria that help release energy and nutrients from food.

While no significant difference between the supplemented and placebo groups were observed for allergic disease overall, the researchers do report that supplementation with the probiotic, prebiotic mixture was associated with a 26 per cent reduction in eczema, while atopic eczema was reduced by 34 per cent.

Faecal samples revealed that the pro-, prebiotic group had significantly higher lactobacilli, propionibacteria, and bifidobacteria populations.

This result, said the researchers, indicated “successful intervention and good adherence.”

“Our prospective study indicates, for the first time to our knowledge, an inverse association between the prevalence of eczema and the abundance of certain species of the indigenous gut microbiota, thus supporting the important role of commensal bacteria in the pathogenesis of eczema,”wrote Kukkonen.

“Gut microbiota contact directly with extensions of dendritic cells, which orchestrate the mucosal immune homeostasis. Commensal bacteria stimulate the innate immune system and contribute to the generation of regulatory lymphocytes, which, through IL-10 and TGF-a, establish and maintain mucosal immune tolerance,”said the researchers.

The results show, they said, that probiotics and prebiotics offer an “easily accessible, inexpensive, and safe”way of reducing eczema in infants, particularly high-risk infants.

The researchers said that continued follow-up on these same infants will show if this effect is maintained later in life, and if any impact on airway allergies such as asthma is observed.

The study was funded by Valio Ltd and the Helsinki University Central Hospital.

Probiotics Used in Human Studies.

Alimentary Tract

Journal of Clinical Gastroenterology. 39(6):469-484 July 2005

Montrose, David C BA *; Floch, Martin H MD +

Abstract: Goal: To investigate the literature from 1980 to 2004 for the types of studies and organisms used as probiotics in human studies and diseases.

Methods: PubMed search for probiotic organisms used in studies from 1980 to August 2004. The data from those papers were evaluated for organisms used, dose, vehicle, frequency, and investigator's report of positive or negative results.

Results: A total of 185 manuscripts were identified. Investigators reported results of both single and multiple organisms in the same manuscript. A single organism was used in 125 reports, and multiple organisms, ranging from 2 to 9, were used in 60 reports. Positive results were reported in 239 clinical situations and negative or no effect results reported in 49 in a total of 288 clinical conclusions drawn by the respective investigators. The studies are tabulated in this review. The vast majority of negative/no effect studies contained only one or two strains. Of the probiotics that contained 3 or more strains, only 5 reported negative/no Effect.

Conclusion: There is a large literature available in credible journals that report benefit of probiotic administration using a wide range of doses, organisms, and clinical situations.