1. Probiotics Supplementation:
What Pharmacists Need To Know
Ali Alhammad, PhD Candidate
Department of Pharmacotherapy and Outcome
Science
VCU School of Pharmacy
January 31, 2012

2. Overview
 What are probiotics
 Probiotics
 Prebiotics
 Mymbiotics
 Efficacy
 How they work??
 Possible health benefits
 Some products
 Regulations
 Safety
 How to choose the high quality products?
 Conclusions

3. Introduction
 How many of you are currently taking a
probiotics or probiotics containing products?

4. What is Probiotics ???
 “for life” in Greek
 Probiotics are live microorganisms, which,
when administered in adequate amounts,
confer a health benefit on the host. FDA
 Modify the endogenous microflora
 Have a positive effect on the host

5. Prebiotics
 Nondigestible food ingredients
 Fructo-oligosaccharides (chicory, inulin)
 Lactulose
 Positively affect the endogenous micro flora
 Stimulate the growth of one or a limited
number of bacterial species
 FOS ⇒ Bifidobacteria
 Lactulose ⇒ Lactobacilli

6. Synbiotics
 A probiotic organism in combination with its
prebiotic food
 Providing both the organism and substrate at
the time of ingestion may offer improved
chance of survival in GI tract

7. Characteristics of Effective
Probiotics
 Able to survive the passage through the digestive
system
 Able to attach to the intestinal epithelia and
colonize
 Able to Maintain good viability and stability of
formulation
 Able to utilize the nutrients and substrates in a
normal diet
 Non-pathogenic and non-toxic
 Capable of exerting a beneficial effect on the
humans

8. Species
 Bacteria
 Lactobacillus
 Acidophilus, reuteri, casei, planatarum,
rhamnosus “GG”
 Bifidobacteria
 Bifidum, breve, infantis, longum
 Streptococcus
 Yeast
 Saccharomyces bulardii

9. History
 Metchnikoff (1907)
 Observed that lactic fermentation of milk
stopped putrefaction
 Suggested that consumption of fermented
products would offer the same benefit to
humans
 The term probiotic was first used in the
1960s
“Death sits in the bowels; a bad
digestion is the root of all evil” -
Hippocrates, ca. 400 BC

10. Intestinal Flora
 1014 viable CFU
 More than 10-times total
cells in the human body
 More than total humans
who have ever lived
 At least 50 genera
 > 500 species in any
single adult
 30 to 40 species
account for 99%
 maintaining the balance of 85% beneficial and 15%
harmful is key to personal wellness and health.

11. How they work ??
 Competition with the pathogen for binding sites
 Bacteriocidal actions
 Lowering intestinal pH
 Production of organic acids
 Immunomodulation
 Metabolic mechanisms including:
 Aiding digestion
 Synthesizing vitamins
 Increasing mineral absorption
 Detoxifying carcinogens

12. Possible Health Benefits
 GI Disorders
 Antibiotics Associated Diarrhea (AAD)
 Irritable Bowel Syndrome (IBS)
 Clostridium difficile Infection (CDI)
 Ulcerative Colitis (UC)
 Pouchitis
 Lactose Intolerance
 Infection with Helicobacter pylori (H. pylori)
 Boosts Immune System
 Other

13. Some Probiotics products
 Activia™ Yogurt  Florastor®
 Align®  Probiotic All-Flora®
 Culturelle®  Nutraelle®
 Lactinex®

14. Activia™ Yogurt
 Claim: “Regulates digestive system”
 Content: Bifidobacterium animalis
 Recommended dose: 1-3 servings (4 oz)/d
 Possibly effective:
 Helicobacter pylori infection
 IBS
 Necrotizing enterocolitis
 Pouchitis
 Rotaviral diarrhea
 Traveler’s diarrhea
 Ulcerative colitis

15. Culturelle®
 Claim: several claims (GI, immune, diarrhea)
 Content: Lactobacillus rhamnosus GG, inulin
 Recommended dose: 1-2 capsules once or
twice daily
 Possibly effective:
 AAD
 Chemotherapy-associated diarrhea
 CDI
 Nosocomial diarrhea
 Traveler’s diarrhea
 Prevention of allergies

16. Align®
 Claim: “Helps support digestive balance”
 Content: Bifidobacterium infantis
 Recommended dose: 1 capsule daily
 Possibly effective:
 Helicobacter pylori infection
 IBS
 Necrotizing enterocolitis
 Pouchitis
 Rotaviral diarrhea
 Traveler’s diarrhea
 Ulcerative colitis

17. Regulation of DS
 1994, Dietary Supplement, Health and
Education Act (DSHEA)
 Not FDA regulated
 FDA bas the “Burden of Proof”
 Must prove that product is “unsafe”
 No FDA enforcement unless can prove
supplement is “unsafe”
 (significant or unreasonable risk of injury)
 Quality control is poor
 80% of preparations tested had 1% or less of the
bacterial concentration on the label

18. Safety
 Generally Recognized as Safe (GRAS) status
 Lactic acid producing bacteria (included)
 Bifidobacteria (not included)
 Safe in literature
 Very rare Endocarditis and Bacteremia
Enterococci
 Greater threat of Endocarditis and Bacteremia
Several reports of fungemia associated
with use of yeast-based probiotics (S.
boulardii)

19. How To Choose…

20. How To Choose…

21. How To Choose…
 Consult your pharmacist and/or doctor

22. Supplement Facts
 Type of bacteria  Expiration/“Best by”
 Amount date
 Storage  Where it is made
 Prebiotics

23. How To Choose …
 Look for standardized supplements (USP
or ConsumerLab certification)
 Contamination

24. Introduction
 How many of you are currently taking a
probiotics or probiotics containing products?

25. Summary
 An old concept, with a new formulations
 Potential therapy for many GI related
diseases and other
 Largely unproven, but growing body scientific
evidence
 Patients need guidance as to which ones to
use, when to use them, how to use them