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PROBIOTICS: REVIEW OF EVIDENCE Amita Avadhani, DNP, DCC, ACNP, ANP, APN, CCRN
What Are Probiotics? “Live microorganisms which when administered in adequate amounts confer a health benefit on the host” -World Health Organization
Functions • Suppress epithelial binding by pathogenic bacteria • Improve intestinal barrier function-protective cytokines • Modulate the immune system –suppress intestinal pro-inflammatory cytokines such as TNF • Resist gastric acid & bile acids • Colonize intestinal tract • Influence cytokines secreted by intestinal epithelial cells
Probiotics Genera • Lactobacillus • Bifidobacterium • Saccharomyces
Most Researched Probiotics 1. Lactobacillus alone or in combination with other genera; Bifidobacterium most common-Majority of studies 2. Saccharomyces, Streptococcus-Few Studies 3. Enterococcus or Bacillus-Even Fewer
INDICATIONS FOR PROBIOTICS Inflammatory Bowel Disease
Levels of Recommendation Level
Description
A
Based on strong, positive, well-conducted controlled studies in the primary literature, which are not in abstract form.
B C
Based on positive controlled studies, but in the presence of some negative studies. Based on some positive studies, but clearly an inadequate amount of data to establish the certainty of a Level A or a Level B recommendation.
Gastro-Intestinal Disorders • Streptococcus • Enterococcus • Bacillus
*Commercial products combine different strains
Common Probiotic Brands: • VSL#3® (Bifidobacterium breve, B. longum, B. infantis, Lactobacillus acidophilus, L. plantarum, L. paracasei, L. bulgaricus, Streptococcus thermophilus) • Align® (B. infantis) • Culturelle® (L. rhamnosus GG) • DanActive® (L. casei) • Mutaflor® (E. coli Nissle 1917) • Florastor® (Saccharomyces boulardii)
Related Terms: • Prebiotics: Nondigestible carbohydrates that stimulate the growth and/or activity of beneficial colonic bacteria. • Synbiotics: Combination of prebiotics and probiotics.
Other Facts-Probiotics
Diarrhea Diarrhea Type Infectious-ChildhoodTreatment Prevention of Infectious diarrhea Prevention of AAD Prevention of Recurrent CDAD Prevention of CDAD
Recommendation A B A B/C B/C
Probiotic Strains S. Boulardii, LGG, L Reuteri S. Boulardii, LGG S. Boulardii, LGG, L Casei + L Bulgaricus+ S. Thermophilus S. Boulardii, LGG, Bacteriotherapy LGG, S Boulardii
Immunity Clinical Condition
Recommendation
Probiotic Strains
Immune system enhancement
A
LGG, Lactobacillus acidophilus, Lactobacillus plantarum, Bifidobacterium lactis and Lactobacillus johnsonii
IBD Type Pouchitis-Prevention
Recommendation A
Probiotic Strains VSL#3
Pouchitis-Remission maintenance Pouchitis-Induce Remission Ulcerative ColitisInduce Remission Ulcerative ColitisMaintenance Crohn’s Disease
A
VSL#3
C
VSL#3
B
E. Coli Nissle, VSL#3
Radiation Enteritis
A
E. Coli Nissle, VSL#3
Clinical Condition
Recommendation
Probiotic Strains
C
E. Coli Nisle, S. Boulardii, LGG
Radiation Enteritis
C
VSL#3 and lactobacillus acidophilus
Irritable Bowel Syndrome Clinical Condition
Recommendation B
Irritable Bowel Syndrome
C
Probiotic Strains Bifidobacterium Infantis, VSL#3 Bifidobacterium Animalis, L. plantarum
Allergies Atopic Eczema Clinical Condition
Recommendation
Probiotic Strains
Atopic Eczema associated with cow’s milk allergy-Treatment
A
LGG, Bifidobacterium lactis
Atopic Eczema associated with cow’s milk allergy-Prevention
A
LGG, Bifidobacterium lactis
Miscellaneous Other Indications Clinical Condition
Recommendation
Probiotic Strains
Bacterial Vaginosis /Vaginitis
C
Lactobacillus acidophilus, LGG and Lactobacillus Reuteri
Urogenital tract Infections
Inconclusive Evidence
Coronary Artery Disease
Inconclusive Evidence
Ventilator Associated Pneumonia
No Benefit
Colon Cancer Prevention
Inconclusive Evidence
Developed from Recommendations of Probiotic Use 2011, third Yale workshop
• Most common routes of administration Oral and Enteral • Other routes -Vaginal, Topical • Single vs combination of strains • Most reported Side Effects within the 1st 3 days • Case Reports of Fungemia/Bacteremia No statistically significant during subgroup analysis • Previously believed interactions with corticosteroids, antibiotics, immune suppressants, dietary therapies, chemotherapy No statistically significance during subgroup analysis • No increased risk based on age • Case reports of serious adverse events with health-compromised status No statistical significance
History of Probiotics: The word ‘probiotic’ originated from a Greek word meaning ‘For Life’. At the forefront of inventions with regard to probiotics are attributed to two scientists; A Russian born scientist, a noble prize winner named Eli Metchnikoff and a French pediatrician Henry Tissier.
Metchnikoff was responsible for the original observation of the positive role played by some selected bacteria. He suggested that "The dependence of the intestinal microbes on the food makes it possible to adopt measures to modify the flora in our bodies and to replace the harmful microbes by useful microbes", Metchnikoff, 1907. Tissier observed that children with diarrhea had in their stools a low number of bacteria characterized by a peculiar, Y shaped morphology. These “bifid” bacteria were, on the contrary, abundant in healthy children He suggested that these bacteria could be administered to patients with diarrhea to help restore a healthy gut flora, Tissier, 1906
Who regulates Probiotics? Food and Drug Administration (FDA) regulates dietary supplement products and ingredients under a different set of regulations than those covering "conventional" foods and drug products. Under the Dietary Supplement Health Education Act (DSHEA) of 1994, the dietary supplement or dietary ingredient manufacturer is responsible for ensuring the safety of the supplement or ingredient before marketing.
FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market. Generally, manufacturers are not required to register their products with FDA nor get FDA approval before producing or selling dietary supplements. Manufacturers are responsible for making sure that the product label information is true and not misleading. Under this act, all domestic as well as foreign companies that manufacture, package, label or hold dietary supplements, including those involved with testing, quality control, and dietary supplement distribution in the U.S., must comply with the Dietary Supplement Current Good Manufacturing Practices (cGMPS) for quality control. Additionally, the manufacturer, packer, or distributor whose name appears on the label of a dietary supplement marketed in the US, is required to report to FDA all serious adverse event reports associated with use of the dietary supplement in the US
Bibliography 1. The National Center for Complementary and Alternative Medicine. The Research Spotlight; the two studies explore the potential health benefits of probiotics, Retrieved, July. 2012. from, http://nccam.nih.gov/research/results/spotlight/110508.htm 2. Food and Agriculture Organization of the United Nations. World Health Organization. (2001). Health and Nutritional Properties of Probiotics in Food Including Powdered milk with live Lactic acid bacteria-A report of a joint FAO/WHO Expert consultation. 3. Floch MH, Walker WA, Madsen K, et al. Recommendations for Probiotic Use-2011 update. Journal of clinical gastroenterology. 2011; 45; S168-S171. 4. Agency for Healthcare Research and Quality. Safety of Probiotics to Reduce Risk and Prevent or Treat Disease. Evidence Report/Technology Assessment. 2011; AHRQ Publication No. 11-E007. 5. Adams CA, The probiotic paradox: live and dead cells are biological response modifiers. Nutrition Research Reviews. 2010; 23, 37–46. 6.Unites States Food and Drug Administration. Dietary Supplements, Retrieved; July, 2012 from; www.fda.gov/food/dietarysupplements/default.htm
