Advertisement

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

      Abstract

      Background & Aims:

      We have recently documented the efficacy of a highly concentrated probiotic preparation (VSL#3) in the prevention of flare-up in patients with chronic pouchitis. The aim of this study was to compare probiotic therapy with VSL#3 versus placebo in the ability to prevent the onset of acute pouchitis during the first year after ileal pouch-anal anastomosis.

      Methods:

      Forty consecutive patients who underwent ileal pouch-anal anastomosis for ulcerative colitis were randomized to receive either VSL#3 (1 packet containing 900 billion bacteria/day) (n = 20) or an identical placebo (n = 20) immediately after ileostomy closure for 1 year. The patients were assessed clinically, endoscopically, and histologically after 1, 3, 6, 9, and 12 months. Health-related quality of life was assessed using the Inflammatory Bowel Disease Questionnaire.

      Results:

      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 (log-rank test, z = 2.273; P < 0.05). Treatment with VSL#3 determined a significant improvement in Inflammatory Bowel Disease Questionnaire score, whereas this was not the case with placebo.

      Conclusions:

      Treatment with VSL#3 is effective in the prevention of the onset of acute pouchitis and improves quality of life of patients with ileal pouch-anal anastomosis.

      Abbreviations:

      CFU (colony-forming units), IBDQ (Inflammatory Bowel Disease Questionnaire), IPAA (ileal pouch-anal anastomosis), PDAI (Pouchitis Disease Activity Index)
      To read this article in full you will need to make a payment
      AGA Member Login
      Login with your AGA username and password.
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'

      Purchase one-time access:

      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

        • Sandborn W.J.
        Pouchitis following ileal pouch-anal anastomosis.
        Gastroenterology. 1994; 107: 1856-1860
        • Svaninger G.
        • Nordgren S.
        • Oresland T.
        • Hulten L.
        Incidence and characteristics of pouchitis in the Koch continent ileostomy and the pelvic pouch.
        Scand J Gastroenterol. 1993; 28: 695-700
        • Penna C.
        • Dozois R.
        • Tremaine W.
        • Sandborn W.
        • LaRusso N.
        • Schleck C.
        • Ilstrup D.
        Pouchitis after ileal pouch-anal anastomosis for ulcerative colitis occurs with increased frequency in patients with associated primary sclerosing cholangitis.
        Gut. 1996; 38: 234-239
        • Stahlberg D.
        • Gullberg K.
        • Liljeqvist L.
        • Hellers G.
        • Löfberg R.
        Pouchitis following pelvic pouch operation for ulcerative colitis. Incidence, cumulative risk, and risk factors.
        Dis Colon Rectum. 1996; 39: 1012-1018
        • Meagher A.P.
        • Farouk R.
        • Dozois R.
        • Kelly K.A.
        • Pemberton J.H.
        J-ileal pouch-anal anastomosis for CUC.
        Br J Surg. 1998; 85: 800-803
        • Fazio V.W.
        • O’Riordain M.G.
        • Lavery I.C.
        • Church J.M.
        • Lau P.
        • Strong S.A.
        • Hull T.L.
        Long-term functional outcome and quality of life after stapled restorative proctocolectomy.
        Ann Surg. 1999; 230: 575-584
        • Simchuk E.J.
        • Thirlby R.C.
        Risk factors and true incidence of pouchitis in patients after ileal pouch-anal anastomoses.
        World J Surg. 2000; 24: 851-856
        • Sandborn W.J.
        Pouchitis.
        in: McLeod R.S. Martin F. Sutherland L.R. Wallace J.L. Williams C.N. Trends in inflammatory bowel disease. Kluwer, Lancaster, England1997: 51-63
        • Madden M.
        • McIntyre A.
        • Nicholls R.J.
        Double blind cross-over trial of metronidazole versus placebo in chronic unremitting pouchitis.
        Dig Dis Sci. 1994; 39: 1193-1196
        • Gionchetti P.
        • Rizzello F.
        • Venturi A.
        • Ugolini F.
        • Rossi M.
        • Brigidi P.
        • Johansson R.
        • Ferrieri A.
        • Poggioli G.
        • Campieri M.
        Antibiotic combination therapy in patients with chronic, treatment-resistant pouchitis.
        Aliment Pharmacol Ther. 1999; 13: 713-718
        • Shen B.
        • Achkar J.P.
        • Lashner B.A.
        • Ormsby A.H.
        • Remzy F.H.
        • Brzezinsky A.
        • Bevins C.L.
        • Bambrick M.L.
        • Seidner D.L.
        • Fazio V.W.
        A randomized clinical trial of ciprofloxacin and metronidazole to treat acute pouchitis.
        Inflamm Bowel Dis. 2001; 7: 301-305
        • Sheperd N.A.
        • Jass J.R.
        • Duval I.
        • Moskowitz R.L.
        • Nicholls R.J.
        • Morson B.C.
        Restorative proctocolectomy with ileal reservoir.
        J Clin Pathol. 1987; 40: 601-607
        • Sandborn W.J.
        • Tremaine W.J.
        • Batts K.P.
        • Pemberton J.H.
        • Phillips S.F.
        Pouchitis after ileal pouch-anal anastomosis.
        Mayo Clin Proc. 1994; 69: 409-415
        • Schaafsma G.
        State of the art concerning probiotic strains in milk products.
        IDF Nutr Newslett. 1996; 5: 23-24
        • Campieri M.
        • Gionchetti P.
        Probiotics in inflammatory bowel disease.
        Gastroenterology. 1999; 116: 1246-1249
        • Shanahan F.
        Probiotics in inflammatory bowel diseases.
        Gut. 2001; 48: 609
        • Fabia R.
        • Ar’Rajab A.
        • Johansson M.-L.
        • Willén R.
        • Andersson R.
        • Molin G.
        • Bengmark S.
        The effect of exogenous administration of Lactobacillus reuteri R2LC and oat fiber on acetic acid-induced colitis in the rat.
        Scand J Gastroenterol. 1993; 28: 155-162
        • Mao Y.
        • Nobaek S.
        • Kasravi B.
        • Adawi D.
        • Stenram U.
        • Molin G.
        • Jeppsson B.
        The effects of Lactobacillus strains and oat fibre on methotrexate-induced enterocolitis in rats.
        Gastroenterology. 1996; 111: 334-344
        • Madsen K.L.
        • Doyle J.S.G.
        • Jewell L.D.
        • Tavernini M.M.
        • Fedorak R.N.
        Lactobacillus species prevents colitis in interleukin-10 gene-deficient mice.
        Gastroenterology. 1999; 116: 1107-1114
        • Schultz M.
        • Veltkamp C.
        • Dieleman L.A.
        • Grenther W.B.
        • Wyrick P.B.
        • Tonkonogy S.L.
        • Sartor R.B.
        Lactobacillus plantarum 299Vs in the treatment and prevention of spontaneous colitis in interleukin-10-deficient mice.
        Inflamm Bowel Dis. 2002; 8: 71-80
        • O’Mahony L.
        • Feeney M.
        • O’Halloran S.
        • Murphy L.
        • Kiely B.
        • Fitzgibbon J.
        • Lee G.
        • O’Sullivan G.
        • Shanahan F.
        • Collins J.K.
        Probiotic impact on microbial flora, inflammation and tumour development in IL-10 knockout mice.
        Aliment Pharmacol Ther. 2001; 15: 1219-1225
        • Murphy L.
        • Byrne F.
        • Collins J.K.
        • Shanahan F.
        • O’Sullivan G.C.
        • Aranda R.
        Evaluation and characterisation of probiotic therapy in the CD45Rbhi transfer model of colitis.
        Gastroenterology. 1999; 116 (abstr): A3382
        • Kruis W.
        • Schuts E.
        • Fric P.
        • Fixa B.
        • Judmaier G.
        • Stolte M.
        Double-blind comparison of an oral Escherichia coli preparation and mesalazine in maintaining remission of ulcerative colitis.
        Aliment Pharmacol Ther. 1997; 11: 853-858
        • Rembacken B.J.
        • Snelling A.M.
        • Hawkey P.M.
        • Axon A.T.R.
        Non-pathogenic Escherichia coli versus mesalazine for the treatment of ulcerative colitis.
        Lancet. 1999; 354: 635-639
        • Kruis W.
        • Fric P.
        • Stolte M.
        • The Mutaflor Study Group
        Maintenance of remission in ulcerative colitis is equally effective with Escherichia coli Nissle 1917 and with standard mesalamine.
        Gastroenterology. 2001; 120 (abstr): A680
        • Gionchetti P.
        • Rizzello F.
        • Venturi A.
        • Brigidi P.
        • Matteuzzi D.
        • Bazzocchi G.
        • Poggioli G.
        • Miglioli M.
        • Campieri M.
        Oral bacteriotherapy as maintenance treatment in patients with chronic pouchitis.
        Gastroenterology. 2000; 119: 305-309
        • Venturi A.
        • Gionchetti P.
        • Rizzello F.
        • Johansson R.
        • Zucconi E.
        • Brigidi P.
        • Matteuzzi D.
        • Campieri M.
        Impact on the faecal flora composition of a new probiotic preparation. Preliminary data on maintenance treatment of patients with ulcerative colitis (UC) intolerant or allergic to 5-aminosalicylic acid (5-ASA).
        Aliment Pharmacol Ther. 1999; 13: 1103-1108
        • Campieri M.
        • Rizzello F.
        • Venturi A.
        • Poggioli G.
        • Ugolini F.
        • Helwig U.
        • Amadini C.
        • Romboli E.
        • Gionchetti P.
        Combination of antibiotic and probiotic treatment is efficacious in prophylaxis of post-operative recurrence of Crohn’s disease a randomized controlled study vs mesalamine.
        Gastroenterology. 2000; 118 (abstr): A4179
        • Madsen K.
        • Cornish A.
        • Soper P.
        • McKaigney C.
        • Jijon H.
        • Yachimec C.
        • Doyle J.
        • Jewell L.
        • De Simone C.
        Probiotic bacteria enhance murine and human intestinal epithelial barrier function.
        Gastroenterology. 2001; 121: 580-591
        • Tiplady B.
        A basic program for constructing a dispensing list for a randomized clinical trial.
        Br J Clin Pharmacol. 1981; 11: 617-618
        • Guyatt G.
        • Mitchell A.
        • Irvine E.J.
        • Singer J.
        • Williams N.
        • Goodacre R.
        • Tompkins C.
        A new measure of health status for clinical trials in inflammatory bowel disease.
        Gastroenterology. 1989; 96: 804-810
      1. Summanen P. Baron E.J. Summanen P. Baron E.S. Citron D.M. Strong C. Wexler H.M. Finegold S.M. Wadswort anaerobic bacteriology manual. 5th ed. STAR, Singapore1993
        • Hartemink R.
        • Domenech V.R.
        • Rombouts F.M.
        LAMVAB.
        J Microb Methods. 1997; 29: 77-84
        • Hartemink R.
        • Kok B.J.
        • Weenk G.H.
        • Rombouts F.M.
        Raffinose Bifidobacterium (RB) agar, a new selective medium for bifidobacteria.
        J Microb Methods. 1996; 27: 33-43
        • Dave R.I.
        • Shah N.P.
        Evaluation of media for selective enumeration of Streptococcus thermophilus, Lactobacillus delbrueckii subsp. bulgaricus, Lactobacillus acidophilus, and bifidobacteria.
        J Dairy Sci. 1996; 76: 1529-1536
        • Timisjärvi A.T.
        • Alatossava T.
        Development of oligonucleotide primers from the 16S-23S rRNA intergenic sequences for identifying different dairy and probiotic lactic acid bacteria by PCR.
        Int J Food Microbiol. 1997; 35: 49-56
        • Kok R.G.
        • De Wall A.
        • Schut F.
        • Welling G.W.
        • Weenk G.
        • Hellingwerf K.J.
        Specific detection and analysis of a probiotic Bifidobacterium strain in infant faeces.
        Appl Environ Microbiol. 1996; 62: 3668-3672
        • Brigidi P.
        • Vitali B.
        • Swennen E.
        • Altomare L.
        • Rossi M.
        • Matteuzzi D.
        Specific detection of Bifidobacterium strains in a new probiotic preparation and in human feces by polymerase chain reaction.
        Syst Appl Microbiol. 2000; 23: 391-399
        • Brigidi P.
        • Vitali B.
        • Swennen E.
        • Bazzocchi G.
        • Matteuzzi D.
        Effects of probiotic administration upon the composition and enzymatic activity of human fecal microbiota in patients with irritable bowel syndrome or functional diarrhea.
        Res Microbiol. 2001; 152: 735-741
        • Ruseler-van-Embden J.G.H.
        • Schouten W.R.
        • van Lieshout L.M.C.
        Pouchitis.
        Gut. 1994; 114:35: 658-664
        • Ulisse S.
        • Gionchetti P.
        • D’Alò S.
        • Russo F.P.
        • Pesce I.
        • Ricci G.
        • Rizzello F.
        • Helwig U.
        • Cifone M.G.
        • Campieri M.
        • De Simone C.
        Expression of cytokines, inducible nitric oxide synthetase and matrix metalloproteinases in pouchitis.
        Am J Gastroenterol. 2001; 96: 2691-2699