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Clinical Study Highlight
Featured Study – November 2003

Prophylaxis of pouchitis onset with probiotic therapy: a double-blind, placebo-controlled trial.

Gastroenterology 2003 May; 124:1202-9

Gionchetti P, Rizzello F, Helwig U, Venturi A, Lammers KM, Brigidi P, Vitali B, Poggioli G, Miglioli M, Campieri M. 2003.

Summary and comments by Mary Ellen Sanders, Ph.D.

An emerging field of study is the ability of probiotics to down-regulate intestinal inflammation. Several research groups are investigating strain-specific effects in animal models of colitis, and human studies are underway with patients suffering from Crohn's disease, ulcerative colitis and pouchitis. The European Union is funding a large, multicenter study through its PROGID project (part of the PROEUHEALTH cluster) on probiotics as therapeutics for IBD and other chronic gut disorders.

One research effort, headed by Dr. Gionchetti from the Department of Internal Medicine at the University of Bologna in Italy, has been especially active in studying probiotics and their impact on pouchitis and inflammatory bowel disease. A study published in the May issue of Gastroenterology reports results from a double-blind, placebo-controlled trial of 40 patients. These patients had all undergone surgery for ulcerative colitis to remove their colon and form an ileal pouch connected to the anus. The resulting ileal pouch serves as the fecal reservoir. Inflammation of this ileal pouch, or pouchitis, is the most common long-term complication from this surgery. Because of the role of bacterial colonization in the etiology of this complication and the short-term effectiveness of antibiotics in treating pouchitis, probiotic bacteria were hypothesized to play a role in preventing the onset of acute pouchitis. The effectiveness of the probiotic test product in reducing recurrence of inflammation in patients with ulcerative colitis and reducing postoperative recurrence of Crohn's disease was documented in previous studies.

The probiotic preparation studied was the commercially available VSL#3 product, which is a blend of 8 lactobacilli and bifidobacteria and delivers 300 billion viable bacteria per gram. Three grams of the probiotic preparation (900 billion probiotic bacteria per day) or a placebo were administered to patients immediately after ileostomy closure. Patients were assessed after 1, 3, 6, 9, and 12 months. Two of the 20 patients (10%) treated with VSL#3 had an episode of acute pouchitis compared with 8 of the 20 patients (40%) treated with placebo. This statistically significant improvement demonstrated that the probiotic product, VSL#3, is an effective treatment for the prevention of the onset of acute pouchitis and improves the quality of life in patients with ileal pouch-anal anastomosis.

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Probiotics, probiotic research and probiotic foods are fast growing topics as consumer awareness continues to increase. The USprobiotics.org site is a comprehensive, up-to-date resource on probiotic reseach and development and the consumer health benefits of probiotics in the United States as well as a reference for global probiotic activities. This site will give consumers, healthcare professionals and industry professionals a good background on the world of probiotics – what they are, what we know about them, and what to consider for commercial and personal use. Probiotic Documentaries Probiotic documentary, sponsored in part by CDRF, is now available on DVD. “Microwarriors. The Power of Probiotics” is the most comprehensive and up-to-date film ever produced on probiotics and their contribution to overall health and well-being. See www.microwarriorsmovie.com. New Video from Council for Agricultural Science and Technology (CAST) examining probiotics launched today. Sponsored in part by CDRF, "Germs with a Positive Attitude" features Drs. Todd Klaenhammer and Mary Ellen Sanders. Press release. See video below. CAST. Webcasts The Health Benefits of Probiotics Presented at the 37th Annual Meeting of the American Academy of Physician Assistants held May 23-28, 2009. Practical Applications of Probiotics in Health and Disease Presented at the 49th Annual Meeting of the American College of Nutrition held October 3, 2008. Proceedings: "Practical Applications of Probiotics in Health and Disease" Additional Webcasts, meeting transcripts and other resources are available here. Free probiotic review articles How Do We Know When Something Called "Probiotic" Is Really a Probiotic? A Guideline for Consumers and Health Care Professionals (2009) Probiotics: Their Potential to Impact Human Health (2007)	Clinical Study Highlight Featured Study – November 2003 Prophylaxis of pouchitis onset with probiotic therapy: a double-blind, placebo-controlled trial. Gastroenterology 2003 May; 124:1202-9 Gionchetti P, Rizzello F, Helwig U, Venturi A, Lammers KM, Brigidi P, Vitali B, Poggioli G, Miglioli M, Campieri M. 2003. Summary and comments by Mary Ellen Sanders, Ph.D. An emerging field of study is the ability of probiotics to down-regulate intestinal inflammation. Several research groups are investigating strain-specific effects in animal models of colitis, and human studies are underway with patients suffering from Crohn's disease, ulcerative colitis and pouchitis. The European Union is funding a large, multicenter study through its PROGID project (part of the PROEUHEALTH cluster) on probiotics as therapeutics for IBD and other chronic gut disorders. One research effort, headed by Dr. Gionchetti from the Department of Internal Medicine at the University of Bologna in Italy, has been especially active in studying probiotics and their impact on pouchitis and inflammatory bowel disease. A study published in the May issue of Gastroenterology reports results from a double-blind, placebo-controlled trial of 40 patients. These patients had all undergone surgery for ulcerative colitis to remove their colon and form an ileal pouch connected to the anus. The resulting ileal pouch serves as the fecal reservoir. Inflammation of this ileal pouch, or pouchitis, is the most common long-term complication from this surgery. Because of the role of bacterial colonization in the etiology of this complication and the short-term effectiveness of antibiotics in treating pouchitis, probiotic bacteria were hypothesized to play a role in preventing the onset of acute pouchitis. The effectiveness of the probiotic test product in reducing recurrence of inflammation in patients with ulcerative colitis and reducing postoperative recurrence of Crohn's disease was documented in previous studies. The probiotic preparation studied was the commercially available VSL#3 product, which is a blend of 8 lactobacilli and bifidobacteria and delivers 300 billion viable bacteria per gram. Three grams of the probiotic preparation (900 billion probiotic bacteria per day) or a placebo were administered to patients immediately after ileostomy closure. Patients were assessed after 1, 3, 6, 9, and 12 months. Two of the 20 patients (10%) treated with VSL#3 had an episode of acute pouchitis compared with 8 of the 20 patients (40%) treated with placebo. This statistically significant improvement demonstrated that the probiotic product, VSL#3, is an effective treatment for the prevention of the onset of acute pouchitis and improves the quality of life in patients with ileal pouch-anal anastomosis.