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• W2140703378 abstract "Background&Aims: The aim of this study was to compare the response of symptoms and cytokine ratios in irritable bowel syndrome (IBS) with ingestion of probiotic preparations containing a lactobacillus or bifidobacterium strain. Methods: Seventy-seven subjects with IBS were randomized to receive either Lactobacillus salivarius UCC4331 or Bifidobacterium infantis 35624, each in a dose of 1 × 1010 live bacterial cells in a malted milk drink, or the malted milk drink alone as placebo for 8 weeks. The cardinal symptoms of IBS were recorded on a daily basis and assessed each week. Quality of life assessment, stool microbiologic studies, and blood sampling for estimation of peripheral blood mononuclear cell release of the cytokines interleukin (IL)-10 and IL-12 were performed at the beginning and at the end of the treatment phase. Results: For all symptoms, with the exception of bowel movement frequency and consistency, those randomized to B infantis 35624 experienced a greater reduction in symptom scores; composite and individual scores for abdominal pain/discomfort, bloating/distention, and bowel movement difficulty were significantly lower than for placebo for those randomized to B infantis 35624 for most weeks of the treatment phase. At baseline, patients with IBS demonstrated an abnormal IL-10/IL-12 ratio, indicative of a proinflammatory, Th-1 state. This ratio was normalized by B infantis 35624 feeding alone. Conclusions: B infantis 35624 alleviates symptoms in IBS; this symptomatic response was associated with normalization of the ratio of an anti-inflammatory to a proinflammatory cytokine, suggesting an immune-modulating role for this organism, in this disorder. Background&Aims: The aim of this study was to compare the response of symptoms and cytokine ratios in irritable bowel syndrome (IBS) with ingestion of probiotic preparations containing a lactobacillus or bifidobacterium strain. Methods: Seventy-seven subjects with IBS were randomized to receive either Lactobacillus salivarius UCC4331 or Bifidobacterium infantis 35624, each in a dose of 1 × 1010 live bacterial cells in a malted milk drink, or the malted milk drink alone as placebo for 8 weeks. The cardinal symptoms of IBS were recorded on a daily basis and assessed each week. Quality of life assessment, stool microbiologic studies, and blood sampling for estimation of peripheral blood mononuclear cell release of the cytokines interleukin (IL)-10 and IL-12 were performed at the beginning and at the end of the treatment phase. Results: For all symptoms, with the exception of bowel movement frequency and consistency, those randomized to B infantis 35624 experienced a greater reduction in symptom scores; composite and individual scores for abdominal pain/discomfort, bloating/distention, and bowel movement difficulty were significantly lower than for placebo for those randomized to B infantis 35624 for most weeks of the treatment phase. At baseline, patients with IBS demonstrated an abnormal IL-10/IL-12 ratio, indicative of a proinflammatory, Th-1 state. This ratio was normalized by B infantis 35624 feeding alone. Conclusions: B infantis 35624 alleviates symptoms in IBS; this symptomatic response was associated with normalization of the ratio of an anti-inflammatory to a proinflammatory cytokine, suggesting an immune-modulating role for this organism, in this disorder. Irritable bowel syndrome (IBS) is a common functional disorder usually defined by the coexistence of abdominal pain or discomfort and an alteration in bowel habit.1Brandt L.J. Locke G.R. Olden K. Quigley E. Schoenfeld P. Schuster M. Talley N. An evidence-based approach to the management of irritable bowel syndrome in North America.Am J Gastroenterol. 2002; 97: S1-S26PubMed Google Scholar, 2Drossman D.A. Camileri M. Mayer E.A. Whitehead W.E. AGA technical review on irritable bowel syndrome.Gastroenterology. 2002; 123: 2108-2131Abstract Full Text Full Text PDF PubMed Scopus (1201) Google Scholar, 3Thompson W.G. Longstreth G.F. Drossman D.A. Heaton K.W. Irvine E.J. Muller-Lissner S.A. 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Evolving pathophysiological models of functional gastrointestinal disorders.Gastroenterology. 2002; 122: 2032-2048Abstract Full Text Full Text PDF PubMed Scopus (286) Google Scholar More recently, roles for enteric infection and intestinal inflammation have been proposed. Thus, both retrospective and prospective studies have documented the new onset of IBS following bacteriologically confirmed bacterial gastroenteritis14McKendrick M.W. Read M.W. Irritable bowel syndrome—post-salmonella infection.J Infect. 1994; 29: 1-3Abstract Full Text PDF PubMed Scopus (280) Google Scholar, 15Neal K.R. Hebdon J. Spiller R. Prevalence of gastrointestinal symptoms six months after bacterial gastroenteritis and risk factors for development of the irritable bowel syndrome.BMJ. 1997; 314: 779-782Crossref PubMed Scopus (526) Google Scholar, 16Gwee K.-A. Leong Y.-L. Graham C. McKendrick M.W. Collins S.M. Walters S.J. Underwood J.E. Read N.W. 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Moochhala S.M. Increased rectal mucosal expression of interleukin 1beta in recently acquired post-infectious irritable bowel syndrome.Gut. 2003; 52: 523-526Crossref PubMed Scopus (365) Google Scholar in patients with IBS. The enteric flora has also been implicated; there has been a suggestion that some patients with IBS may harbor bacterial overgrowth and that their symptoms may be ameliorated by its eradication.28Pimentel M. Chow E.J. Lin H.C. Eradication of small bowel bacterial overgrowth reduces symptoms of irritable bowel syndrome.Am J Gastroenterol. 2000; 95: 3503-3506Crossref PubMed Google Scholar, 29Pimentel M. Chow E. Lin H. Normalization of lactulose breath testing correlates with symptom improvement in irritable bowel syndrome a double-blind, randomized, placebo-controlled study.Am J Gastroenterol. 2003; 98: 412-419PubMed Google Scholar, 30Tursi A. Brandimarte G. Giorgetti G.M. 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The immunomodulation of enteric neuromuscular function implications for motility and inflammatory disorders.Gastroenterology. 1996; 111: 1683-1699Abstract Full Text PDF PubMed Scopus (456) Google Scholar the role of lumen-mucosa interactions in IBS remains largely unexplored. Probiotics, defined as live or attenuated bacteria or bacterial products that confer a significant health benefit to the host,34Gorbach S.L. Probiotics in the third millennium.Dig Liver Dis. 2002; 34: S2-S7Abstract Full Text PDF PubMed Scopus (82) Google Scholar have the potential to provide a clinical tool to explore these interactions. There are several reasons why these agents might, in theory, prove of therapeutic benefit in IBS. Firstly, many probiotic organisms exert antibacterial and antiviral effects and could thereby prevent or modify the course of postinfective IBS.35Isolauri E. Kirjavainen P.V. Salminen S. Probiotics a role in the treatment of intestinal infection and inflammation?.Gut. 2002; 50: iii54-iii59Crossref PubMed Scopus (274) Google Scholar, 36Von Wright A. Salminen S. Probiotics established effects and open questions.Eur J Gastroenterol Hepatol. 1999; 11: 1195-1198Crossref PubMed Scopus (35) Google Scholar Secondly, probiotics have been demonstrated to exert anti-inflammatory effects at mucosal surfaces37O’Mahony L. Feeney M. O’Halloran S. Murphy L. Kiely B. Fitzgibbon J. Lee G. O’Sullivan G. Shanahan F. Collins K. Probiotic impact on microbial flora, inflammation, and tumour development in IL-10 knockout mice.Aliment Pharmacol Ther. 2001; 15: 1219-1225Crossref PubMed Scopus (246) Google Scholar, 38McCarthy J. O’Mahony L. O’Callaghan L. Sheil B. Vaughan E.E. Fitzsimons N. Fitzgibbon J. O’Sullivan G.C. Kiely B. Collins J.K. Shanahan F. Double blind, placebo controlled trial of two probiotic strains in interleukin 10 knockout mice and mechanistic link with cytokine balance.Gut. 2003; 52: 975-980Crossref PubMed Scopus (402) Google Scholar; by reducing mucosal inflammation, probiotics could decrease immune-mediated activation of enteric motor and sensory neurons and modify neural traffic between the gut and the central nervous system. Thirdly, probiotics could alter the composition of the gut flora. While the status of the gut flora in IBS remains a source of some controversy,12Quigley E.M.M. Current concepts of the irritable bowel syndrome.Scand J Gastroenterol. 2003; 38: 1-8Crossref Scopus (43) Google Scholar, 39Bradley H.K. Wyatt G.M. Bayliss C.E. Hunter J.O. Instability in the faecal flora of a patient suffering from food-related irritable bowel syndrome.J Med Microbiol. 1987; 23: 29-32Crossref PubMed Scopus (58) Google Scholar, 40Balsari A. Ceccarelli A. Dubini F. Fesce E. Poli G. The fecal microbial population in the irritable bowel syndrome.Microbiologica. 1982; 5: 185-194PubMed Google Scholar probiotic-related changes in the enteric flora could directly (through the augmentation of commensal lactobacilli or bifidobacteria or the elimination of pathogens) or indirectly (through a reduction in either pathogen-related inflammation or bacterial fermentation41King T.S. Elia M. Hunter J.O. Abnormal colonic fermentation in irritable bowel syndrome.Lancet. 1998; 352: 1187-1189Abstract Full Text Full Text PDF PubMed Scopus (410) Google Scholar) influence gut function. Finally, probiotics could alter the volume and/or composition of stool and gas42Jiang T. Savaiano D.A. Modification of colonic fermentation by bifidobacteria and pH in vitro impact on lactose metabolism, short-chain fatty acid, and lactate production.Dig Dis Sci. 1997; 42: 2370-2377Crossref PubMed Scopus (67) Google Scholar or increase intestinal mucus secretion,43Ouwehand A.C. Lagstrom H. Suomalainen T. Salminen S. Effect of probiotics on constipation, fecal azoreductase activity and fecal mucin content in the elderly.Ann Nutr Metab. 2002; 46: 159-162Crossref PubMed Scopus (162) Google Scholar effects that could influence intestinal handling of its contents and thus modulate symptoms such as constipation and diarrhea. A small number of studies have evaluated the response of IBS to probiotic preparations; while results between studies are difficult to compare because of differences in study design, probiotic dose, and strain, there has been some, but by no means consistent, evidence of symptom improvement.44Halpern G.M. Prindiville T. Blankenburg M. Hsia T. Gershwin M.E. Treatment of irritable bowel syndrome with Lacteol Fort a randomized, double-blind, cross-over trial.Am J Gastroenterol. 1996; 91: 1579-1585PubMed Google Scholar, 45Nobaek S. Johansson M.L. Molin G. Ahrne S. Jeppsson B. Alteration of intestinal microflora is associated with reduction in abdominal bloating and pain in patients with irritable bowel syndrome.Am J Gastroenterol. 2000; 95: 1231-1238Crossref PubMed Google Scholar, 46O’Sullivan M.A. O’Morain C.A. Bacterial supplementation in the irritable bowel syndrome A randomised double-blind placebo-controlled crossover study.Dig Liver Dis. 2000; 32: 302-304Abstract Full Text PDF PubMed Google Scholar, 47Brigidi 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: 735-741Crossref PubMed Scopus (166) Google Scholar, 48Niedzielin K. Kordecki H. Birkenfeld B. A controlled, double-blind, randomized study on the efficacy of Lactobacillus plantarum 299V in patients with irritable bowel syndrome.Eur J Gastroenterol Hepatol. 2001; 13: 1143-1147Crossref PubMed Scopus (442) Google Scholar, 49Sen S. Mullan M.M. Parker T.J. Woolner J.T. Tarry S.A. Hunter J.O. Effect of Lactobacillus plantarum 299v on colonic fermentation and symptoms of irritable bowel syndrome.Dig Dis Sci. 2002; 47: 2615-2620Crossref PubMed Scopus (218) Google Scholar, 50Bazzocchi G. Gionchetti P. Almerigi P.F. Amadini C. Campieri M. Intestinal microflora and oral bacteriotherapy in irritable bowel syndrome.Dig Liver Dis. 2002; 34: s48-s53Abstract Full Text PDF PubMed Scopus (54) Google Scholar, 51Adler S.N. Jacob H. Eliakim R. The probiotic agent E-Coli strain ATCC20226 has a healing effect on proximal inflammation of the small bowel.Gastroenterology. 2002; 122 (abstr): A527Google Scholar, 52Parker P. McNaught C.E. Anderson A.D.G. Mitchell C.J. MacFie J. Synbiotic in irritable bowel syndrome a double blind prospective randomised controlled trial.Gut. 2003; 52 (abstr): A11Google Scholar, 53Kim H.J. Camilleri M. McKinzie S. Lempke M.B. Burton D.D. Thomforde G.M. Zinsmeister A.R. A randomized controlled trial of a probiotic, VSL#3, on gut transit and symptoms in diarrhoea-predominant irritable bowel syndrome.Aliment Pharmacol Ther. 2003; 17: 895-904Crossref PubMed Scopus (423) Google Scholar The overall impact of probiotics in IBS remains unclear.54Barbara G. Corinaldesi R. Probiotics could they turn out to be ineffective in irritable bowel syndrome?.Dig Liver Dis. 2000; 32: 294-301Abstract Full Text PDF PubMed Google Scholar, 55Hamilton-Miller J.M.T. Probiotics in the management of irritable bowel syndrome a review of clinical trials.Microb Ecol Health Dis. 2001; 13: 212-216Crossref Scopus (49) Google Scholar, 56Thompson W.G. Probiotics for irritable bowel syndrome a light in the darkness?.Eur J Gastroenterol Hepatol. 2001; 13: 1135-1136Crossref PubMed Scopus (14) Google Scholar, 57Madden J.A. Hunter J.O. A review of the role of the gut microflora in irritable bowel syndrome and the effects of probiotics.Br J Nutr. 2002; 88: S67-S72Crossref PubMed Google Scholar, 58Floch M.H. Probiotics, irritable bowel syndrome, and inflammatory bowel disease.Curr Treat Options Gastroenterol. 2003; 6: 283-288Crossref PubMed Google Scholar Several of these studies have involved either lactobacilli or bifidobacteria, although none have involved a direct comparison of these strains.55Hamilton-Miller J.M.T. Probiotics in the management of irritable bowel syndrome a review of clinical trials.Microb Ecol Health Dis. 2001; 13: 212-216Crossref Scopus (49) Google Scholar Patients were recruited from gastroenterology clinics at Cork University Hospital and by direct advertisement on the university campus and in a local newspaper. Individuals aged between 18 and 75 years who satisfied Rome II criteria for the diagnosis of IBS3Thompson W.G. Longstreth G.F. Drossman D.A. Heaton K.W. Irvine E.J. Muller-Lissner S.A. Functional bowel disorders and functional abdominal pain.Gut. 1999; 45: II43-II47Crossref PubMed Scopus (2021) Google Scholar and in whom organic gastrointestinal diseases, including inflammatory bowel disease, and clinically significant systemic diseases had been excluded were considered for inclusion in the study. Pregnant women, individuals with known lactose intolerance or immunodeficiency, and individuals who had undergone any abdominal surgery, with the exception of hernia repair and appendectomy, were excluded. Each potentially eligible patient was evaluated by a full review of clinical history and performance of a physical examination as well as full blood count, serum chemistry, and quantitative serum immunoglobulin levels. Clinically significant abnormalities in any of the latter test results led to exclusion from randomization. Eligible subjects then entered a 4-week run-in period during which they recorded symptoms, as well as stool frequency and form, each day on a diary card. During this time and throughout the rest of the study, subjects were instructed not to take any medications that could influence gut motor or absorptive function, including laxatives and antidiarrheal agents, as well as any preparation that could alter the enteric flora, including antibiotics and commercially available probiotic preparations. At the end of the run-in period, subjects were randomized to receive either a lactobacillus or bifidobacterium, each delivered in a dose of 1 × 1010 live bacterial cells in a malted milk drink, or the malted milk drink alone as placebo. All preparations were identical in color, taste, and consistency. Randomization was performed by picking a card from a pack of prerandomized identical cards in the presence of a study coordinator; all other investigators, as well as patients, remained blinded to the randomization process until completion of the trial. Subjects were instructed to ingest the preparation once a day, in the morning, for 8 weeks and record symptoms and stool characteristics on a daily basis throughout the study period. Compliance was assessed by direct questioning at clinic visits and by fecal flora analysis. On completion of the 8-week treatment phase, subjects continued to complete the daily symptom cards for a further 4-week washout period while off all therapy. The probiotic preparations used in this study, Lactobacillus salivarius subspecies salivarius UCC4331 and Bifidobacterium infantis 35624, were originally isolated from the ileocecal region of an adult human undergoing reconstructive surgery. These strains were selected on the basis of the following probiotic properties: being of human origin, nonpathogenic, and resistant to intestinal acid and bile; demonstrating an ability to adhere to human epithelial cells; and demonstrating an ability to temporarily colonize and be metabolically active within the human gastrointestinal tract.59Dunne C. O’Mahony L. Murphy L. Thornton G. Morrissey D. O’Halloran S. Feeney M. Flynn S. Fitzgerald G. Daly C. Kiely B. O’Sullivan G.C. Shanahan F. Collins K. In vitro selection criteria for probiotic bacteria of human origin correlation with in vivo findings.Am J Clin Nutr. 2001; 73: 886S-892SGoogle Scholar, 60Dunne C. Murphy L. Flynn S. O’Mahony L. O’Halloran S. Feeney M. Morrissey D. Thornton G. Fitzgerald G. Daly C. Kiely B. Quigley E.M.M. O”Sullivan G.C. Shanahan F. Collins J.K. Probiotics: from myth to reality Demonstration of functionality in animal models of disease and in human clinical trials.Antonie Van Leeuwenhoek. 1999; 76: 279-292Crossref PubMed Scopus (355) Google Scholar Furthermore, these organisms have been previously shown in volunteer studies to survive transit through the gastrointestinal tract, to be free of side effects, and to demonstrate anti-inflammatory activity in a number of models.60Dunne C. Murphy L. Flynn S. O’Mahony L. O’Halloran S. Feeney M. Morrissey D. Thornton G. Fitzgerald G. Daly C. Kiely B. Quigley E.M.M. O”Sullivan G.C. Shanahan F. Collins J.K. Probiotics: from myth to reality Demonstration of functionality in animal models of disease and in human clinical trials.Antonie Van Leeuwenhoek. 1999; 76: 279-292Crossref PubMed Scopus (355) Google Scholar, 61Collins J.K. Dunne C. Murphy L. Morrissey D. O’Mahony L. O’Sullivan E. Fitzgerald G. Kiely B. O’Sullivan G.C. Daly C. Marteau P. Shanahan F. A randomised controlled trial of a probiotic Lactobacillus strain in healthy adults assessment of its delivery, transit, and influence on microbial flora and enteric immunity.Microb Ecol Health Dis. 2002; 14: 81-89Crossref Scopus (45) Google Scholar L salivarius UCC4331 was cultured in de Man/Rogosa/Sharp broth (Oxoid, Basingstoke, United Kingdom) at 37°C in an anaerobic environment for 24 hours. B infantis 35624 was cultured in de Man/Rogosa/Sharp broth enriched with cysteine at 37°C in an anaerobic environment for 48 hours. Throughout the entire study, subjects were seen on a weekly basis and diary cards collected. The following 3 cardinal IBS symptom clusters were assessed: (1) abdominal pain or discomfort, (2) bloating or distention, and (3) bowel movement difficulty. The latter could reflect either difficulty with evacuation (ie, straining or a sense of incomplete evacuation) or urgency. Each symptom was evaluated using both an ordinal scale (Likert scale; maximum score, 7) and a 10-cm visual analogue scale (VAS; maximum score, 10).62Veldhuyzen Van Zanten S.J. Talley N.J. Bytzer P. Klein K.B. Whorwell P.J. Zinsmeister A.R. Design of trials for functional gastrointestinal disorders.Gut. 1999; 45: II68-II77Google Scholar A composite score, comprised of the sums of the 3 cardinal symptoms (pain/discomfort, bloating/distention, and bowel movement difficulty scores) was also calculated for each patient (maximum score: Likert scale, 21; VAS, 30). Bowel movement frequency was recorded as number per day, and consistency was evaluated using the Bristol Stool Scale.63Heaton K.W. O’Donnell L.J. An office guide to whole-gut transit time Patients’ recollection of their stool form.J Clin Gastroenterol. 1994; 19: 28-30Crossref PubMed Scopus (140) Google Scholar Quality of life was assessed by administration of an IBS-specific questionnaire developed and validated by Drossman et al64Drossman D.A. Patrick D.L. Whitehead W.E. Toner B.B. Diamant N.E. Hu Y. Jia H. Bangdiwala S.I. Further validation of the IBS-QOL a disease-specific quality-of-life questionnaire.Am J Gastroenterol. 2000; 95: 999-1007Crossref PubMed Google Scholar at the time of randomization and at the end of the treatment and washout periods. The following 8 domains were assessed on each occasion in each patient: dysphoria, interference with activity, body image, health worry, food avoidance, social reaction, sexual function, and impact on relationships. Blood samples for blood count, serum chemistry, and quantitative immunoglobulin levels were obtained at initial evaluation and at the end of the study and analyzed using standard laboratory methods. Stool samples for fecal flora analysis were obtained at randomization and at the end of the treatment phase. Spontaneous rifampicin-resistant variants of both probiotic strains were isolated before initiation of this study to facilitate the differentiation of these bacteria from all other lactobacilli and bifidobacteria. Representative fecal suspensions were serially diluted and plated on de Man/Rogosa/Sharp agar containing rifampicin or de Man/Rogosa/Sharp agar containing cysteine and rifampicin to enumerate L salivarius UCC4331 or B infantis 35624, respectively. Peripheral blood samples from patients with IBS was obtained both before and after treatment for cytokine levels and compared with that obtained from a group of age- and sex-matched healthy volunteers (n = 20). Peripheral blood samples were taken directly into sterile EDTA-containing Vacutainers (Econo-med, Long Sutton, United Kingdom). Mononuclear cells were isolated by Ficoll-Hypaque density centrifugation65Boyum A. Separation of leukocytes from blood and bone marrow.Scand J Clin Lab Invest Suppl. 1968; 97: 7PubMed Google Scholar and resuspended at 1 × 106 cells/mL in complete media/Dulbecco’s modified Eagle medium containing 25 mmol/L glucose, 10% fetal calf serum, 1% nonessential amino acids, 50 U/mL penicillin, and 50 μg/mL streptomycin (Invitrogen, Paisley, Scotland). These mononuclear cells are termed peripheral blood mononuclear cells (PBMCs). PBMCs were incubated, nonstimulated, for 72 hours at 37°C in a 5% co2 humidified atmosphere. Nonstimulated PBMC cytokine production reflects the cytokine milieu from which the PBMCs were originally isolated. Cell-free supernatants were stored frozen at −70°C and analyzed for cytokine levels in batches. Interleukin (IL)-10 and IL-12p40 cytokine levels were measured using enzyme-linked immunosorbent assays (R&D Systems, Abington, United Kingdom). All data were collected and analyzed independently of the investigators, who did not have access to the data or to its analysis until the latter had been completed. All of the efficacy analyses were summarized on data from all evaluative subjects" @default.
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• W2140703378 title "Lactobacillus and bifidobacterium in irritable bowel syndrome: Symptom responses and relationship to cytokine profiles" @default.
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