Transcript No Slide Title

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.
Our View
of
Germs...
Our View of Germs...
• All bacteria are bad and scary...
• But that’s OK. Now we have antibiotics...
• We also have irradiation, and domestic
antibacterials...
KILL THEM ALL?
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
Gastrointestinal Microflora
• Gastrointestinal microflora consists of friendly bacteria
• Aid digestion and enhance the body’s 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
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
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
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.
What’s 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.
The Search, and Discovery of a
New and Unique Probiotic
Presented by
Patricia Conway, Ph.D.
VRI BioMedical
Probiotics
•Definition and concept of probiotics
•Not all probiotics are the same
•The search for the perfect probiotic
•Research
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
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
FAO/WHO Guidelines for Probiotics
2001 FAO/WHO Guidelines for Probiotics:
pH Survival
Resistant to gastric juices and bile, allowing them
to survive passage through the digestive tract
Capability to adhere firmly to the mucosa, colonize
Colonization and remain viable in the intestines
Identity
Strain and viable concentration at the end of shelf
life should be stated on label.
Dosing
Dosage regimens and recommended use should be
based on scientific evidence.
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.
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.
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
Lactobacillus fermentum PCC
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.
Comparative in vitro adhesion at
various sites
4.50E+06
3.00E+06
1.50E+06
0.00E+00
ns. stom.
L.fermentum PCC
s. stom.
intestine
L.fermenum LMG 8896
caecum
colon
L.casei ATCC 393
Source: Welin A, Farthing M, Conway PL. (Colonization of ileal mucosa). Publication in preparation, 2002.
Association with Peyers Patches

Scanning electron micrograph of L.fermentum
PCC-like cells on
 A) Peyers Patches
 B) Non-lymphoid small intestinal tissue
Preferential Adhesion to Peyer’s
Patches
1.00E+06
7.50E+05
5.00E+05
2.50E+05
0.00E+00
Peyer's Patches
L.fermentum PCC
Intestine
L.delbruckii
Source: Plant L, Conway PL. Association of Lactobacillus spp with Peyers Patches in mice.
Clinical and Diagnostic Immunology 2002;8(2):320-324.
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 Peyer’s 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.
Prevalence of Common GI Disturbances
Gastrointestinal disturbances
(%)
placebo
L.fermentum PCC
L.acidophilus (DOCIDUS)
80
70
60
50
40
30
20
10
0
1
2
3
Time (weeks)
Source: Conway PL, Blomberg L. Reduction in incidence and severity of diarrhoea in
soldiers consuming Lactobacillus fermentum KLD. Publication in preparation, 2002.
4
Prevalence of Traveler’s Diarrhea
placebo
L.fermentum PCC
L.acidophilus (DOCIDUS)
70
Diarrhoea (%)
60
50
40
30
20
10
0
1
2
3
Time (weeks)
Source: Conway PL, Blomberg L. Reduction in incidence and severity of diarrhoea in
soldiers consuming Lactobacillus fermentum KLD. Publication in preparation, 2002.
4
Development of Common, Minor GI Disturbances
Degree of gastrointestinal
related disturbances
placebo
L.fermentum PCC
L.acidophilus (DOCIDUS)
2.2
2
1.8
1.6
1.4
1.2
1
2
3
4
Time (weeks)
Source: Conway PL, Blomberg L. Reduction in incidence and severity of diarrhoea in
soldiers consuming Lactobacillus fermentum KLD. Publication in preparation, 2002.
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
Lactobacillus fermentum PCC
* 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.
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.
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.
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
A
• 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.
B
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
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 68°F (20°C)
Pharmanex has obtained exclusive rights to L. fermentum
PCC
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