Probiotics Supplementation:

What Pharmacists Need To Know

Ali Alhammad, PhD CandidateDepartment of Pharmacotherapy and Outcome

ScienceVCU School of Pharmacy

January 31, 2012

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

Introduction

How many of you are currently taking a probiotics or probiotics containing products?

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

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

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

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

Characteristics of Effective Probiotics

Species

Bacteria Lactobacillus

Acidophilus, reuteri, casei, planatarum, rhamnosus “GG”

Bifidobacteria Bifidum, breve, infantis, longum

Streptococcus

Yeast Saccharomyces bulardii

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

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.

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

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

Some Probiotics products

Activia™ Yogurt Align® Culturelle®

Lactinex®

Florastor®

Probiotic All-Flora®

Nutraelle®

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

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

Culturelle®

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

Align®

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

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)

How To Choose…

How To Choose…

How To Choose…

Consult your pharmacist and/or doctor

Supplement Facts

Type of bacteria Amount Storage

Expiration/“Best by” date

Where it is made Prebiotics

How To Choose …

Look for standardized supplements (USP or ConsumerLab certification) Contamination

Introduction

How many of you are currently taking a probiotics or probiotics containing products?

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