Drug Criteria & Outcomes: ‘Montezuma's revenge' to refractory pouchitis? Survey says: Probiotics
Drug Criteria & Outcomes
'Montezuma's revenge' to refractory pouchitis? Survey says: Probiotics
By Frank T. Mitchell, PharmD Candidate
Auburn (AL) University Harrison School of Pharmacy
Probiotics are defined as "viable microorganisms that (when ingested) have a beneficial effect in the prevention and treatment of specific pathologic conditions."1 Probiotics have been used for centuries to aid in healing or "normalizing" the human body's gastrointestinal (GI) tract. It wasn't until the turn of the century that the "father of immunology," Elie Metchnikoff noticed that Bulgarian peasants consuming milk products that contained fermenting bacteria seemed to live longer, healthier lives.2
There have been many mechanisms proposed by which these bacteria exert their effect and each species or strain has its own niche in which it operates at its maximum benefit. They act by enzymatically degrading toxic materials in the GI tract, attaching or colonizing areas to prevent pathogenic species from obtaining a foothold, and producing environments in which they are better fitted to thrive instead of other species. Most of the bacteria found in the human gut convert lactose into lactic acid, which by itself isn't necessarily caustic to exogenous species. However, coupled with the shear numbers of normal microflora that are able to replicate in their specialized environment, pathogenic strains such as E.coli and Clostridium aren't able to achieve the numbers needed to cause clinically significant disease.
Beneficial species of bacteria, such as those found within probiotics, are ubiquitous in the food we eat. Yogurt, sauerkraut, alcoholic beverages of many types, kimchi, and some organic baby formulas all contain some form of healthy bacteria.
There also is a plethora or non-FDA-regulated supplements, pharmaceutical-grade supplements, and medical foods available that contain probiotic genera to varying degrees (see Table). Not all supplements have the same ratios, combinations, or even the same strains within them. Those deemed to contain "Lactobacillus" actually may include one or many of several thousand species under this particular family. Many of these products also have identical types of side effects that require monitoring. For example, increased stomach gas that usually dissipates with continued usage, chest pain, endocarditis, worsening CNS function in patients with hepatic encephalopathy, vomiting, diarrhea, burping, flatulence, phlegm production, and rash have all been reported with probiotics containing Lactobacillus.3-6
There also have been case reports of two infants receiving Culturelle® as a dietary supplement in the setting of short bowel syndrome that developed Lactobacillus septicemia. Upon removal of the probiotic and treatment with antibiotics the infections cleared.7 Most products indicate safety in children 12 years of age and older with varying dosing regimens depending on the disease state or condition being treated.
To date, there is little scientific evidence that directly promotes any one species over another with regard to treating disease.
There are many small trials with limited data comparing a probiotic product to placebo, but no head-to-head trials comparing one product to another were found. Emerging data and ongoing trials are showing promising results in the conditions of diarrhea (both infectious and antibiotic-associated), HIV/AIDS-associated diarrhea, irritable bowel syndrome, ulcerative colitis, Crohn's disease, enteral feeding diarrhea, small bowel bacterial overgrowth, pouchitis, H. pylori gastroenteritis, and lactose intolerance. Though the power of many of these trials is diminished by relatively small study populations, low consistency of the species being tested, and length of study, many arrive at the same positive outcomes under correlative study conditions.
Most of the current studies alone are weak; however, probiotic therapy warrants reconsideration due to new emerging studies and replicative positive results. Probiotics are a unique group of products because of their use in both treating disease and enhancing overall health in a variety of patient settings. Ultimately, probiotics may have a significant place in therapy for an array of gastrointestinal conditions.
References
- Gionchetti P, Rizzello F, Helwig U, et al. Prophylaxis of pouchitis onset with probiotic therapy: A double-blind placebo-controlled trial. Gastroenterology 2003;124:1,202-1,209.
- Innvista. Available at: www.innvista.com/HEALTH/nutrition/biotics/probiot.htm. Accessed May 22, 2006.
- University of Auburn. Available at: https://ducnt43.duc.auburn.edu/ahfsfirst/NSAHFSFirstFdbrefmain.asp. Accessed May 12, 2006.
- Facts and Comparisons. Available at: http://online.factsandcomparisons.com/search.aspx?search=Flora-q. Accessed May 12, 2006.
- Lexi-Comp Online. Available at: www.crlonline.com/crlsql/servlet/crlonline. Accessed May 12, 2006.
- VSL Pharmaceuticals. Available at: www.vsl3.com/VSL3/default.asp. Accessed May 19, 2006.
- Kunz A, Noel J, Fairchok M. Two cases of Lactobacillus bacteremia during probiotic treatment of short gut syndrome. J Pediatr Gastroenterol Nutr 2004;38:457-458.
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