Patricia Conway, Ph'D'

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Microflora, Probiotics, and the Gastrointestinal
Defense System
Presented by Patricia Conway, Ph.D. VRI
BioMedical Mark Bartlett, Ph.D. Pharmanex
This material has been prepared by Pharmanex to
be used in conjunction with general educational
events and activities only. Alterations or
modifications of this presentation without the
express approval of Pharmanex is prohibited.
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Our View of Germs...
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Our View of Germs...

• All bacteria are bad and scary...
• But thats OK. Now we have antibiotics...
• We also have irradiation, and domestic
  antibacterials...
• KILL THEM ALL?

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Your Digestive Defense System

• Gastrointestinal Microflora
• Friendly and unfriendly bacteria form a delicate
  balance
• Colonization begins at birth continuing through
  life, leading to
• 400 different bacterial species
• 100 trillion bacteria
• 10x number of cells than the rest of the body
• 70 of human immune system localized in
  digestive tract
• Two pounds of total body weight
• Highly concentrated in the colon (1012)
• accounts for half of the volume of contents in
  the colon

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Gastrointestinal Microflora

• Gastrointestinal microflora consists of friendly
  bacteria
• Aid digestion and enhance the bodys own
  digestive immune response
• Friendly bacteria create an intestinal ecosystem
  that inhibits the growth of undesirable bacteria
• compete for essential nutrients
• produce inhibitory substances
• compete for adherence to intestinal mucosa

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A Delicate Balance

• Delicate balance interrupted by
• stress, traveling, alcohol consumption, certain
  foods, and a poor diet
• Implications of microflora imbalance
• Common, minor symptoms of gastrointestinal (GI)
  malaise
• Bowel irregularity
• Occasional diarrhea
• Other digestive and non-digestive discomforts

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Gastrointestinal Microflora A Delicate Balance

• Ideally, your flora should form a nice, thick
  lawn making it difficult for weeds to gain a
  foot-hold.
• Compete for essential nutrients
• Produce inhibitory substances
• Compete for adherence to intestinal mucosa

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When it Starts

• At birth - digestive tract of humans is sterile.
• Colonised by microbes within the first few days
  of life
• At first, predominantly bifidobacteria (breast
  fed infants).
• With the introduction of other foods, a diverse
  microbial population develops in the
  gastrointestinal tract.
• By now, of all the cells in a human body, the
  overwhelming majority are non-human.

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Whats in it for us?

• Fortifies Digestive Defense System
• Helps control occasional GI discomfort
• Promotes digestive comfort and regularity
• Supports healthy function of urinary tract
• Immunomodulation
• Inhibits growth and adhesion of undesirable
  organisms
• Cell protection

These statements have not been evaluated by the
Food and Drug Administration. This product is
not intended to diagnose, treat, cure, or prevent
any disease.
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The Search, and Discovery of a New and Unique
Probiotic
Presented by Patricia Conway, Ph.D. VRI
BioMedical
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Probiotics

• Definition and concept of probiotics
• Not all probiotics are the same
• The search for the perfect probiotic
• Research

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Probiotic Definition

• A product containing viable, defined
  microorganisms in sufficient numbers, which alter
  the microflora and exert beneficial effects in
  the host. Salminen S, Bouley C, et al. (1998).
  
• Not all strains are the same
• Most common species are Lactobacillus and
  Bifidobacterium
• Genus... Species... STRAIN

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Requirements for an Effective Probiotic

• Administered in a form that maintains its
  viability
• Have the capacity to survive passage into the
  intestine
• Survive conditions in the intestine
• Attach to the intestinal wall
• Demonstrable biological activity
• Stable biological activity in the product

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FAO/WHO Guidelines for Probiotics
Source Joint FAO/WHO Expert consultation on
evaluation of health and nutritional properties
of probiotics in food including powder milk with
live lactic acid bacteria. Córdoba, Argentina.
October 1-4, 2001.
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Lactobacillus fermentum PCC

• Proprietary, patent-pending strain of
  Lactobacillus fermentum PCC
• Isolated from Swedish woman with extraordinary
  resilience
• A unique strain with unique properties
• Survives acidic intestinal environment
• Ability to colonize the intestine
• Clinically proven to ? occasional GI complaints
  and increase growth of friendly organisms

These statements have not been evaluated by the
Food and Drug Administration. This product is
not intended to diagnose, treat, cure, or prevent
any disease.
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A Unique Strain with Unique Properties

• Of human intestinal origin
• Survives acid, bile, digestive enzymes
• Ability to colonize the intestine
• Inhibits growth of undesirable organisms
• Preferentially targets immune sites

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L. fermentum PCC Adhesion Rate
L .amylovorus
L. fermentum PCC

• L. fermentum PCC has superior adhesion to
  intestinal mucosal cells
• Good adhesion indicates viability and may lead
  to prolonged colonization

Source Welin A, Farthing M, Conway PL.
(Colonization of ileal mucosa). Publication in
preparation, 2002.
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Comparative in vitro adhesion at various sites
Source Welin A, Farthing M, Conway PL.
(Colonization of ileal mucosa). Publication in
preparation, 2002.
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Association with Peyers Patches

• Scanning electron micrograph of L.fermentum
  PCC-like cells on
• A) Peyers Patches
• B) Non-lymphoid small intestinal tissue

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Preferential Adhesion to Peyers Patches
Source Plant L, Conway PL. Association of
Lactobacillus spp with Peyers Patches in mice.
Clinical and Diagnostic Immunology
20028(2)320-324.
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Clinical Substantiation - L. fermentum PCC

• Twelve clinical studies
• To evaluate stability, colonization, and
  clinical efficacy
• ? symptoms of occasional diarrhea, and
  occasional GI complaints including constipation,
  flatulence, bloating, and abdominal discomfort
• Sixteen pre-clinical and in vitro studies
• Strain is stable and survives transit through
  digestive tract
• Colonization after a single dose average
  duration of colonization is 14 days
• Adherence to human intestinal mucosa
• Preferentially targets Peyers Patch

Supported by independent published research.
References available upon request.
These statements have not been evaluated by the
Food and Drug Administration. This product is
not intended to diagnose, treat, cure, or prevent
any disease.
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Prevalence of Common GI Disturbances
Source Conway PL, Blomberg L. Reduction in
incidence and severity of diarrhoea in soldiers
consuming Lactobacillus fermentum KLD.
Publication in preparation, 2002.
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Prevalence of Travelers Diarrhea
Source Conway PL, Blomberg L. Reduction in
incidence and severity of diarrhoea in soldiers
consuming Lactobacillus fermentum KLD.
Publication in preparation, 2002.
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Development of Common, Minor GI Disturbances
Source Conway PL, Blomberg L. Reduction in
incidence and severity of diarrhoea in soldiers
consuming Lactobacillus fermentum KLD.
Publication in preparation, 2002.
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Lactobacillus fermentum PCC

• Colonizes the human digestive tract
• Inhibits growth of undesirable bacteria
• Supports immune the response
• Reduces occasional GI disturbances in clinical
  trials
• Is stable

These statements have not been evaluated by the
Food and Drug Administration. This product is
not intended to diagnose, treat, cure, or prevent
any disease.
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ProBio PCC
Maintains a Healthy Gastrointestinal Environment
Presented by Mark Bartlett, Ph.D. Senior
Scientist, New Product Development
These statements have not been evaluated by the
Food and Drug Administration. This product is
not intended to diagnose, treat, cure, or prevent
any disease.
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ProBio PCC from Pharmanex

• Proprietary, patent-pending strain of
  Lactobacillus fermentum PCC
• Isolated from Swedish woman with extraordinary
  resilience
• A unique strain with unique properties
• Survives acidic intestinal environment
• Ability to colonize the intestine
• Clinically proven to ? occasional GI complaints
  and increase growth of friendly organisms

These statements have not been evaluated by the
Food and Drug Administration. This product is
not intended to diagnose, treat, cure, or prevent
any disease.
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Clinical Substantiation

• Maintains healthy intestinal microflora
• promotes proliferation of desirable bacteria
  while inhibiting growth of undesirable bacteria
• Supports mucosal immunity
• supports humoral immune response
• acts as a protective barrier

• Decrease in occasional GI complaints, including
  occasional diarrhea
• supports growth and adhesion of desirable
  bacteria
• Supports urinary tract health

Supported by independent published research.
References available upon request.
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Recommended Usage

• For adults who experience occasional diarrhea,
  constipation, or cramps resulting from distressed
  digestive flora.
• For adults who experience occasional
  gastrointestinal disturbances, such as gas or
  bloating.
• For adults who are currently taking other
  probiotics.
• Directions For Use
• Take one capsule daily.
• Take continuously for best results.
• If you are pregnant or lactating, or taking a
  prescription medication, consult a physician
  prior to use.
• Complementary Products - Digestive Formula,
  NutriFi

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ProBio PCC - Competitive Advantage

• Proprietary and patent-pending
• Conforms to FAO/WHO guidelines
• Supported by clinical studies
• Developed according to the 6S Process
• Unique delivery system
• 2 billion CFUs at the end of shelf life
• Does not require refrigeration store at or
  below 68F (20C)

Pharmanex has obtained exclusive rights to L.
fermentum PCC
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