Probiotic Formula

Scientific Summary of “Anti-diarrhoeal Probiotic”

Caution: This formulation is on the basis of scientific study, not on the basis of clinical trial report in Bangladesh; anyone tries to implement this formulation for product development the author will not take any responsibility.


Prepared by:
Muhammad Zahidul Hoque
Chairman & CEO
Bio-Xin
Email: zahid@bio-xin.com
Mobile: +88 01708 411471

Name of the Product: Anti-diarrheal Probiotic
Composition: Saccharomyces boulardii + Mannan-Oligosaccharide (Bio-MOS)
Ingredients per capsule/sachet:S. boulardii 5 billion CFU
Bio-MOS: 200 mg

Other Ingredients:

Maltodextrin, Magnesium stearate (vegetable source) and silicon dioxide
General Description: S. boulardii is a probiotic supplement that survives stomach acid and colonizes intestinal tract. It promotes the health of the intestinal tract; helps protect its beneficial microbiota, and enhance immune function. Additionally it synthesizes vitamin B1, B2, pantothenic acid, vitamin B6, nicotinic acid. S. boulardii stimulate brush-border membrane (BBM) enzymes viz. sucrose-isomaltase (+82%), lactase (+77%) and maltase-glucoamylase (+75%). As a result oral administarion of S. boulardii improved disaccharide activities, enhanced the absorption of D-glucose coupled to Na+ by the symport glucose/Na+ and expression of the sodium-glucose cotransporter-1(SLGT-1) in the brush border of the remaining intestinal segments. S. boulardii cell contain substantial amounts of polyamines (673 nmol/100 mgof lyophilized preparation of S. boulardii); in light of the well-known physiological effects of polyamines on cell maturation, enzyme expression and membrane transport mechanisms.
MannanOligosaccharide is an oligosaccharide from the cell walls of S. cerevisiae that can prevent bad bacteria from adhering to the epithelial cells and reduce their proliferation. Additionally, MOS is an all natural complex carbohydrate which serves as a substrate for the growth of specific beneficial bacteria in the lower gut. It exhibits a prebiotics-like effect that influences cecal microflora and prevents the colonization of pathogens.

Why S. boulardii + MOS for diarrhoeal treatment:

The antidiarrhoeal effect of lyophilized S. boulardii has been investigated in several forms of diarrhoeal diseases. The clinical efficacy of the yeast has been clearly demonstrated for both the prevention of Antibiotic Associated Diarrhoea (AAD) and the treatment of recurrent C. difficile disease. The superiority of probiotic yeast over probiotic bacteria in this indications because of natural resistance of yeast to antibacterial antibiotics, which leaves intact their viability and probiotic properties in the GI-tract.

Mechanism of action of S. boulardii:

• Several studies using animal and cell models indicated that S. boulardii exert a beneficial effect against various enteric pathogens such as C. difficile, Vibrio cholera, Salmonella, Shigella and E. coli by two mechanisms: 1) production of factors that neutralized bacterial toxin and modulation of the host cell signaling pathway implicated in proinflamatory response during bacterial infection.
• S. boulardii produce antitoxin (a 54 kDa serine protease that acted by proteolysis of both the toxin A and its receptor) against C. difficile toxin (Toxin A, a 308 kDa protein) which is a major cause of fluid secretion, increased mucosal permeability, mucosal damage and inflammatory mediators release.
• In vitro studies demonstrated that S. boulardii produces a 120 kDa protein that inhibit Choleara toxin-stimulated chloride secretion by reducing the formation of cyclic AMP.
• S. boulardii synthesized a phosphatase that can dephosphorylate endotoxins such as LPS from from E. coli O55B5 and partially inactivated its cytotoxic effects.
• S. boulardii cell walls present binding properties for cholera toxin (CT) and EHEC
• In vitro studies have demonstrated that exposure of cells to S. boulardii before the addition of bacteria prevents the EPEC- (enteropathogenic E. coli) and EHEC (Enterohaemorrhagic E. coli)-induced decrease in transepithelial resistance and IL-8 secretion, suggesting that the yeast exerted a preventive effect.
• The yeast has been shown to abolish phosphorylation of the myosin light chain that is associated with a cytoskeletal protein involved in intercellular tight junctions control.
• S. boulardii inhibits EPEC- or EHEC induced NF-kB DNA-binding activity and activation of Mitogen activated protein kinase (MAPK) assocated signaling pathway.
• Production of antitoxin factors as well as modification of proinflamatory responses of the host cell by S. boulardii also account for the protective eefect of bacterial infection.

MOS Modes of action:

a) Binding pathogen:
MOS occupy the bacterial binding sites (lectins on the hair like projections known as pilli) on the surface of the pathogens, thus preventing the binding of pathogens to the mucosal wall. MOS binds with them and the complex can then be flushed out of the animal.

b) Starving pathogens of sugars need for growth:
MOS is not digested by intestinal enzymes of human and animal because animals do not have the enzymes that can act on MOS, but in fact is a substrate for the growth of beneficial bacteria.

Product indication:

1. Treatment of simple diarrhoea
2. Treatment and prevention of antibiotic associated complication: diarrhoea, colitis, candidiasis
3. Prevention of diarrhoea associated with continuous eternal feeding in adults.
4. Overall gastrointestinal well being.

Dosage:

Oral route: 1 or 2 sachets or capsules, given once or twice daily.

Direction of USE:

Oral route:
This probiotic supplement can be taken at any time but, in order to obtain very rapid effect, it is best to avoid periods when digestion is taking place. However, it can be taken at the same time as a dose of antibiotic, whenever the latter is given. This Probiotic supplement should not be mixed with a liquid which is too much hot or which contain alcohol.
Dosage form capsules: either sallows the capsules with a mouthful of fluid.
Dosage form sachet: pour content of the sachet into some water or sugar and water, mix and sallow.
Safety: this product is safe for children, men and women of all ages.
Interaction: On account of its fungal nature, S. boulardii is sensitive to antifungal antibiotics and to some quinoleine derivatives.

Side effect:

S. boulardii is generally recognized as safe (GRAS) and safe for everyone. However, if anyone experience negative side effects, consults your health care professional immediately.

Who would or should use the product:

1. People who suffering in diarrhoea associated with antibiotic stress and as a result of GI complications.
2. People who recently been prescribed or completed antibiotic.
3. People who want to be general well being.

Who should not use the product?

No exceptions.

Frequently asked question (FAQ):

What is the difference between this product and other antidiarrhoeal product in the market?
“Rena Anti-diarrhoeal Probiotic” is a formula containing strain of S. boulardii and MannanOligosaccharide that has a lot of clinical evidence against diarrhoea and complication associated with antibiotic therapy. Other products in the market for diarrhoea treatment contain single or multi-strain of Lactobacillus which can’t be use concomitantly with antibiotic therapy because Lactobacillus are susceptible to antibiotics.

Why does this product contain MOS?
MOS is cell wall extract of S. cerevisiae in which many pathogenic bacteria bind and exit intestine without attaching to the epithelium cell. MOS may also enhance health by stimulating antibody production.

Does this need to be refrigerated?
This product needs not refrigeration but refrigeration is recommended for extended shelf life.

Similar Products:

1. BioFlor 250, Biocodex, France
2. Saccharomyces boulardi + MOS, Jarrow Formulas, USA. www.jarrow.com