pro biotics im sig

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Probiotics

Integrative Medicine SIG

APA Meetings

May 1, 2006

David K. Becker, MD, MPHUCSF Department of Pediatrics

“You’ve been fooling around with alternative medicine, haven’t you?”



Outline

What are probiotics and how do they work

Current proposed uses and a look at some of the evidence

Issues in prescribing their use



Probiotics: definitions

World Health Organization:

“live microorganisms which when administered in adequateamounts confer a health benefit on the host”

A bacterial strain that:

Survives the stomach acid and bile

Adheres to intestinal lining

Grows and establishes temporary residence in the

intestines Imparts health benefits

R Fuller. Probiotics: The Scientific Basis. London: Chapman and Halls. 1992



Probiotics

Lactobacillus sp.

reuteri

casei

ramnosus

acidophilus

Streptococcus sp. Bifidobacterium sp.

infantis

lactis

longum

breve bifidum

Sacharomyces boulardii (non-human)

VSL no.3



Probiotics

Colonization at birth

Similar to maternal species

Specific organisms vary by

age in first year Become established by 1

year

In children and adults, “Successful” treatment with

probiotics leads to temporarycolonization only



Probiotics: Proposed uses

Infectious diarrhea

Antibiotic-associated diarrhea

IBD, IBS, and pouchitis

Necrotizing Enterocolitis

Bacterial vaginosis Recurrent UTI’s

Atopic diseases

Immune system enhancement

H pylori infections

Dental caries

Radiation induced diarrhea

Cardiovascular risk reduction

Constipation

Rheumatoid arthritis




Rating the Evidence Floch et al (2006) Natural Standard (2006)

Infectious diarrhea A B

Antibiotic-associateddiarrhea

A C

Diarrhea prevention B B

IBS C B Atopicdermatitis/Allergy

B? B/C

Ratings: A: strong B: good C: fair

Floch, et al. Recommendations for Probiotic Use. J Clin Gastro. 40(3). 2006www.naturalstandard.com




Rating the Evidence Floch et al (2006) Natural Standard (2006)

Ulcerative colitis C B

Crohn’s disease C

H pylori infection C A

NEC C

Bacterial vaginosis C CUTI’s C

Ratings: A: strong B: good C: fair

Floch, et al. Recommendations for Probiotic Use. J Clin Gastro. 40(3). 2006

www.naturalstandard.com



Probiotics: the evidence

Antibiotic-associated diarrhea:

D’Souza et al (BMJ 2002)

Systematic review of 9 placebo-controlled studies (2 in children)

Various probiotics (4 uses S Bouladarii )

60% reduction in antibiotic associated diarrhea compared withplacebo (OR 0.37, 95% CI 0.26-0.53)

Vanderhoof et al (J Pediatr 1999)

202 children, 6 mo - 10 yr, otitis/pharyngitis, amox/amox-clav

Oral antibiotics in an outpatient setting for 10 days

Lactobacillus GG , 10 (<12kg) or 20 (>12kg) billion cfu’s for 10 d Rated stool consistency and frequency

26% of controls and 8% of L GG had diarrhea

Of those with diarrhea, 5.9 days in placebo, 4.7 days in L GG




Infectious diarrhea:

Van Niel et al (Peds 2002)

Systematic review of 9 studies (all outside US, 1-36 months)

Various probiotics (4 used L GG )

Mean reduction in diarrhea of 0.7 days (95% CI: 0.3-1.2) 1.6 fewer stools in L GG groups (95% CI: 0.7-2.6)

Dose response curve with higher L GG dose

Two other meta-analyses also showed benefits, particularly with LGG

Allen et al. Cochrane Database Syst Rev , 2004 Szajewska et al. J Pediatr Gastroenterol Nutr , 2001




Prevention of infections in day care:

Weizman et al (Peds 2005)

Double-blind, placebo-controlled RCT

14 day care centers in Israel, 4-10 months of age

Formula with B lactis , L reuteri , or no probiotics (no breastfeeding) Mean intake: 1 billion orgs

Intervention and follow-up totaled 12 weeks

Both probiotic groups had: Fewer febrile episodes

Fewer diarrhea episodes

Shorter diarrhea episodes

No difference in rate or duration of respirator illnesses

L reuteri group did significantly better than B lactis group



Probiotics: prescribing

Which organism to use?

Which product?

For what conditions?

What dose?

For How long?

Any side effects to be aware of?

How much does it cost?




Lactobacillus GG best studied to date

Combination products not well studied, but

may work as well 10 billion organisms/d

Keep in fridge

Give in cool food/drink

2% risk bloating/gas




ConsumerLab.com tested 25 probiotic products

19 for general population, 3 for children, 3 yogurts

8 claimed a specific number of organisms per serving

13 claimed only a number of organisms at time of manufacture

8/25 contained less than 1 percent of the claimednumber of live bacteria or of the expected minimum of 1 billion.

7 of the 8 that gave expected numbers per serving metthose counts

None contaminated with bacteria, mold, or fungus

All enteric-coated capsules passed testing




ABC Dophilus Jarro-DophilusEPS

Baby’s Jarro-Dophilus

Culturelle

Organisms B bifidum

S thermophilus

B infantis

L rhamnosus

L casei

L plantarum

L acidophilus

B longum

B breve

P adidilactici

L diacetylactis

B breve

B lactis

Blongum

B bifidum

L casei

L rhamnosus

Lactobacillus GG

Quantity per “dose” 1 bill total orgs 4.4 bill total orgs 3 bill total orgs 10 billion orgs

(Consumer Labs)

Cost per dose for 9-10 billorgs/dose

$4.00 $0.57 $0.69 $0.67




Nature’s Way

PrimidophilusNature’s Way

Primidophilusfor children

Nature’s Way

Primidophilusfor kids -chewable

Nature’s Way

Primidophilusjunior

Organisms L acidophilus

L rhamnosus

B longum

B infantis L acidophilus

L rhamnosus

B longum

L acidophilus L rhamnosus

B breve

B longum B infantis

L acidophilus

L rhamnosus

Quantity per “dose”

2.9 bill total orgs 1.5 bill orgs

(Consumer Labs)

1 bill total orgs 1 bill total orgs


$0.50

(30-60doses/cont)

$1.88

(8 doses/cont)

$1.33

(3 doses/cont)

$1.50

(9 doses/cont)




Nature Madeacidophilus

Breyers 99% FatFree Fruit on theBottom…

Stonyfield FarmFrench VanillaNonfat Yogurt

UAS Labs DDSJunior

Organisms L acidophilus L acidophilus

? others

Bifidus ?

L acidophilus L casei

L bulgaricus

L reuteri

B infantis

L acidophilus FOS

Quantity per “dose”

500 million

(Consumer Labs)

1 billion org ??

(8 oz cont.)

(Consumer Labs)

1 bill total orgs ??

(8 oz cont.)

(Consumer Labs)

2 (?5) bill totalorgs

(Consumer Labs)


$5.00

(2 doses/cont.)

? $$$ ? $$$ $1.00

(14 doses/cont)



Take home points…

Good evidence for:

Infectious diarrhea

Antibx-assoc diarrhea

Promising evidence for:

Prevention of infectiousdiarrhea

Prevention of atopicconditions

other uses?

In the future we may be usingprobiotics as we use antibioticstoday: with specific strains usedfor certain clinical situationsguided by controlled studies

Prescribing

Lactobacillus GG beststudied to date

Combination productsnot well studied, but may

work as well 10 billion organisms/d

Keep in fridge

Give in cool food/drink

2% risk bloating/gas



Studies at UCSF

Probiotics to prevent antibiotic-associateddiarrhea in hospitalized children (Andi Shane,

MD) 2mo - 12 yrs

L GG, 10 billion cfu’s, given throughout

antibiotic course



Studies at UCSF

Trial of Infant Probiotic Supplementation toPrevent Asthma (TIPS) (Michael Cabana,

MD) L GG , 10 billion cfu’s, given within 2 weeks for

6 months

Follow development of asthma over 3 years

Beginning recruitment

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