Clinical trial NCT04557215 - References

Irritable Bowel Syndrome With Diarrhea — Efficacy and Safety of Rifaximin With NAC in IBS-D

Citation(s)

•   Bassotti G, Villanacci V, Maurer CA, Fisogni S, Di Fabio F, Cadei M, Morelli A, Panagiotis T, Cathomas G, Salerni B
  The role of glial cells and apoptosis of enteric neurones in the neuropathology of intractable slow transit constipation. Gut. 2006 Jan;55(1):41-6. doi: 10.1136/gut.2005.073197. Epub 2005 Jul 24.
•   Cuoco L, Salvagnini M
  Small intestine bacterial overgrowth in irritable bowel syndrome: a retrospective study with rifaximin. Minerva Gastroenterol Dietol. 2006 Mar;52(1):89-95.
•   Debbia EA, Maioli E, Roveta S, Marchese A
  Effects of rifaximin on bacterial virulence mechanisms at supra- and sub-inhibitory concentrations. J Chemother. 2008 Apr;20(2):186-94. doi: 10.1179/joc.2008.20.2.186.
•   Ermund A, Schutte A, Johansson ME, Gustafsson JK, Hansson GC
  Studies of mucus in mouse stomach, small intestine, and colon. I. Gastrointestinal mucus layers have different properties depending on location as well as over the Peyer's patches. Am J Physiol Gastrointest Liver Physiol. 2013 Sep 1;305(5):G341-7. doi: 10.1152/ajpgi.00046.2013. Epub 2013 Jul 5.
•   Eshraghi A, Maldonado-Arocho FJ, Gargi A, Cardwell MM, Prouty MG, Blanke SR, Bradley KA
  Cytolethal distending toxin family members are differentially affected by alterations in host glycans and membrane cholesterol. J Biol Chem. 2010 Jun 11;285(24):18199-207. doi: 10.1074/jbc.M110.112912. Epub 2010 Apr 12.
•   Fodor AA, Pimentel M, Chey WD, Lembo A, Golden PL, Israel RJ, Carroll IM
  Rifaximin is associated with modest, transient decreases in multiple taxa in the gut microbiota of patients with diarrhoea-predominant irritable bowel syndrome. Gut Microbes. 2019;10(1):22-33. doi: 10.1080/19490976.2018.1460013. Epub 2018 Jul 18.
•   Frisk A, Lebens M, Johansson C, Ahmed H, Svensson L, Ahlman K, Lagergard T
  The role of different protein components from the Haemophilus ducreyi cytolethal distending toxin in the generation of cell toxicity. Microb Pathog. 2001 Jun;30(6):313-24. doi: 10.1006/mpat.2000.0436.
•   Gerard L, Garey KW, DuPont HL
  Rifaximin: a nonabsorbable rifamycin antibiotic for use in nonsystemic gastrointestinal infections. Expert Rev Anti Infect Ther. 2005 Apr;3(2):201-11. doi: 10.1586/14787210.3.2.201.
•   Giamarellos-Bourboulis EJ, Pyleris E, Barbatzas C, Pistiki A, Pimentel M
  Small intestinal bacterial overgrowth is associated with irritable bowel syndrome and is independent of proton pump inhibitor usage. BMC Gastroenterol. 2016 Jul 11;16(1):67. doi: 10.1186/s12876-016-0484-6.
•   Ji S, Park H, Lee D, Song YK, Choi JP, Lee SI
  Post-infectious irritable bowel syndrome in patients with Shigella infection. J Gastroenterol Hepatol. 2005 Mar;20(3):381-6. doi: 10.1111/j.1440-1746.2005.03574.x.
•   Jiang ZD, DuPont HL
  Rifaximin: in vitro and in vivo antibacterial activity--a review. Chemotherapy. 2005;51 Suppl 1:67-72. doi: 10.1159/000081991.
•   Johansson ME, Sjovall H, Hansson GC
  The gastrointestinal mucus system in health and disease. Nat Rev Gastroenterol Hepatol. 2013 Jun;10(6):352-61. doi: 10.1038/nrgastro.2013.35. Epub 2013 Mar 12.
•   Lackner JM, Gudleski GD, Zack MM, Katz LA, Powell C, Krasner S, Holmes E, Dorscheimer K
  Measuring health-related quality of life in patients with irritable bowel syndrome: can less be more? Psychosom Med. 2006 Mar-Apr;68(2):312-20. doi: 10.1097/01.psy.0000204897.25745.7c.
•   Leite GGS, Morales W, Weitsman S, Celly S, Parodi G, Mathur R, Sedighi R, Barlow GM, Rezaie A, Pimentel M
  Optimizing microbiome sequencing for small intestinal aspirates: validation of novel techniques through the REIMAGINE study. BMC Microbiol. 2019 Nov 1;19(1):239. doi: 10.1186/s12866-019-1617-1.
•   Lembo A, Pimentel M, Rao SS, Schoenfeld P, Cash B, Weinstock LB, Paterson C, Bortey E, Forbes WP
  Repeat Treatment With Rifaximin Is Safe and Effective in Patients With Diarrhea-Predominant Irritable Bowel Syndrome. Gastroenterology. 2016 Dec;151(6):1113-1121. doi: 10.1053/j.gastro.2016.08.003. Epub 2016 Aug 13.
•   Lovell RM, Ford AC
  Global prevalence of and risk factors for irritable bowel syndrome: a meta-analysis. Clin Gastroenterol Hepatol. 2012 Jul;10(7):712-721.e4. doi: 10.1016/j.cgh.2012.02.029. Epub 2012 Mar 15.
•   Lupascu A, Gabrielli M, Lauritano EC, Scarpellini E, Santoliquido A, Cammarota G, Flore R, Tondi P, Pola P, Gasbarrini G, Gasbarrini A
  Hydrogen glucose breath test to detect small intestinal bacterial overgrowth: a prevalence case-control study in irritable bowel syndrome. Aliment Pharmacol Ther. 2005 Dec;22(11-12):1157-60. doi: 10.1111/j.1365-2036.2005.02690.x.
•   Majewski M, McCallum RW
  Results of small intestinal bacterial overgrowth testing in irritable bowel syndrome patients: clinical profiles and effects of antibiotic trial. Adv Med Sci. 2007;52:139-42.
•   Mearin F, Lacy BE, Chang L, Chey WD, Lembo AJ, Simren M, Spiller R
  Bowel Disorders. Gastroenterology. 2016 Feb 18:S0016-5085(16)00222-5. doi: 10.1053/j.gastro.2016.02.031. Online ahead of print.
•   Mearin F, Perez-Oliveras M, Perello A, Vinyet J, Ibanez A, Coderch J, Perona M
  Dyspepsia and irritable bowel syndrome after a Salmonella gastroenteritis outbreak: one-year follow-up cohort study. Gastroenterology. 2005 Jul;129(1):98-104. doi: 10.1053/j.gastro.2005.04.012.
•   Mokhtari V, Afsharian P, Shahhoseini M, Kalantar SM, Moini A
  A Review on Various Uses of N-Acetyl Cysteine. Cell J. 2017 Apr-Jun;19(1):11-17. doi: 10.22074/cellj.2016.4872. Epub 2016 Dec 21.
•   Neal KR, Barker L, Spiller RC
  Prognosis in post-infective irritable bowel syndrome: a six year follow up study. Gut. 2002 Sep;51(3):410-3. doi: 10.1136/gut.51.3.410.
•   Okhuysen PC, Jiang ZD, Carlin L, Forbes C, DuPont HL
  Post-diarrhea chronic intestinal symptoms and irritable bowel syndrome in North American travelers to Mexico. Am J Gastroenterol. 2004 Sep;99(9):1774-8. doi: 10.1111/j.1572-0241.2004.30435.x.
•   Ordog T, Takayama I, Cheung WK, Ward SM, Sanders KM
  Remodeling of networks of interstitial cells of Cajal in a murine model of diabetic gastroparesis. Diabetes. 2000 Oct;49(10):1731-9. doi: 10.2337/diabetes.49.10.1731.
•   Oriano M, Terranova L, Teri A, Sottotetti S, Ruggiero L, Tafuro C, Marchisio P, Gramegna A, Amati F, Nava F, Franceschi E, Cariani L, Blasi F, Aliberti S
  Comparison of different conditions for DNA extraction in sputum - a pilot study. Multidiscip Respir Med. 2019 Jan 31;14:6. doi: 10.1186/s40248-018-0166-z. eCollection 2019.
•   Pickett CL, Whitehouse CA
  The cytolethal distending toxin family. Trends Microbiol. 1999 Jul;7(7):292-7. doi: 10.1016/s0966-842x(99)01537-1.
•   Pimentel M, Chatterjee S, Chow EJ, Park S, Kong Y
  Neomycin improves constipation-predominant irritable bowel syndrome in a fashion that is dependent on the presence of methane gas: subanalysis of a double-blind randomized controlled study. Dig Dis Sci. 2006 Aug;51(8):1297-301. doi: 10.1007/s10620-006-9104-6. Epub 2006 Jul 11.
•   Pimentel M, Chow EJ, Lin HC
  Eradication of small intestinal bacterial overgrowth reduces symptoms of irritable bowel syndrome. Am J Gastroenterol. 2000 Dec;95(12):3503-6. doi: 10.1111/j.1572-0241.2000.03368.x.
•   Pimentel M, Chow EJ, Lin HC
  Normalization of lactulose breath testing correlates with symptom improvement in irritable bowel syndrome. a double-blind, randomized, placebo-controlled study. Am J Gastroenterol. 2003 Feb;98(2):412-9. doi: 10.1111/j.1572-0241.2003.07234.x.
•   Pimentel M, Lembo A, Chey WD, Zakko S, Ringel Y, Yu J, Mareya SM, Shaw AL, Bortey E, Forbes WP; TARGET Study Group
  Rifaximin therapy for patients with irritable bowel syndrome without constipation. N Engl J Med. 2011 Jan 6;364(1):22-32. doi: 10.1056/NEJMoa1004409.
•   Pimentel M, Lembo A
  Microbiome and Its Role in Irritable Bowel Syndrome. Dig Dis Sci. 2020 Mar;65(3):829-839. doi: 10.1007/s10620-020-06109-5.
•   Pimentel M, Morales W, Pokkunuri V, Brikos C, Kim SM, Kim SE, Triantafyllou K, Weitsman S, Marsh Z, Marsh E, Chua KS, Srinivasan S, Barlow GM, Chang C
  Autoimmunity Links Vinculin to the Pathophysiology of Chronic Functional Bowel Changes Following Campylobacter jejuni Infection in a Rat Model. Dig Dis Sci. 2015 May;60(5):1195-205. doi: 10.1007/s10620-014-3435-5. Epub 2014 Nov 26.
•   Pimentel M, Morales W, Rezaie A, Marsh E, Lembo A, Mirocha J, Leffler DA, Marsh Z, Weitsman S, Chua KS, Barlow GM, Bortey E, Forbes W, Yu A, Chang C
  Development and validation of a biomarker for diarrhea-predominant irritable bowel syndrome in human subjects. PLoS One. 2015 May 13;10(5):e0126438. doi: 10.1371/journal.pone.0126438. eCollection 2015.
•   Pimentel M, Park S, Mirocha J, Kane SV, Kong Y
  The effect of a nonabsorbed oral antibiotic (rifaximin) on the symptoms of the irritable bowel syndrome: a randomized trial. Ann Intern Med. 2006 Oct 17;145(8):557-63. doi: 10.7326/0003-4819-145-8-200610170-00004.
•   Posserud I, Stotzer PO, Bjornsson ES, Abrahamsson H, Simren M
  Small intestinal bacterial overgrowth in patients with irritable bowel syndrome. Gut. 2007 Jun;56(6):802-8. doi: 10.1136/gut.2006.108712. Epub 2006 Dec 5.
•   Purdy D, Buswell CM, Hodgson AE, McALPINE K, Henderson I, Leach SA
  Characterisation of cytolethal distending toxin (CDT) mutants of Campylobacter jejuni. J Med Microbiol. 2000 May;49(5):473-479. doi: 10.1099/0022-1317-49-5-473.
•   Pyleris E, Giamarellos-Bourboulis EJ, Tzivras D, Koussoulas V, Barbatzas C, Pimentel M
  The prevalence of overgrowth by aerobic bacteria in the small intestine by small bowel culture: relationship with irritable bowel syndrome. Dig Dis Sci. 2012 May;57(5):1321-9. doi: 10.1007/s10620-012-2033-7. Epub 2012 Jan 20.
•   Rumessen JJ
  Ultrastructure of interstitial cells of Cajal at the colonic submuscular border in patients with ulcerative colitis. Gastroenterology. 1996 Dec;111(6):1447-55. doi: 10.1016/s0016-5085(96)70005-7.
•   Sadowska AM, Verbraecken J, Darquennes K, De Backer WA
  Role of N-acetylcysteine in the management of COPD. Int J Chron Obstruct Pulmon Dis. 2006;1(4):425-34. doi: 10.2147/copd.2006.1.4.425.
•   Shah ED, Basseri RJ, Chong K, Pimentel M
  Abnormal breath testing in IBS: a meta-analysis. Dig Dis Sci. 2010 Sep;55(9):2441-9. doi: 10.1007/s10620-010-1276-4. Epub 2010 May 14.
•   Sharara AI, Aoun E, Abdul-Baki H, Mounzer R, Sidani S, Elhajj I
  A randomized double-blind placebo-controlled trial of rifaximin in patients with abdominal bloating and flatulence. Am J Gastroenterol. 2006 Feb;101(2):326-33. doi: 10.1111/j.1572-0241.2006.00458.x.
•   Shenker BJ, Hoffmaster RH, Zekavat A, Yamaguchi N, Lally ET, Demuth DR
  Induction of apoptosis in human T cells by Actinobacillus actinomycetemcomitans cytolethal distending toxin is a consequence of G2 arrest of the cell cycle. J Immunol. 2001 Jul 1;167(1):435-41. doi: 10.4049/jimmunol.167.1.435.
•   Smith JL, Bayles DO
  The contribution of cytolethal distending toxin to bacterial pathogenesis. Crit Rev Microbiol. 2006 Oct-Dec;32(4):227-48. doi: 10.1080/10408410601023557.
•   Spiller RC, Jenkins D, Thornley JP, Hebden JM, Wright T, Skinner M, Neal KR
  Increased rectal mucosal enteroendocrine cells, T lymphocytes, and increased gut permeability following acute Campylobacter enteritis and in post-dysenteric irritable bowel syndrome. Gut. 2000 Dec;47(6):804-11. doi: 10.1136/gut.47.6.804.
•   Streutker CJ, Huizinga JD, Campbell F, Ho J, Riddell RH
  Loss of CD117 (c-kit)- and CD34-positive ICC and associated CD34-positive fibroblasts defines a subpopulation of chronic intestinal pseudo-obstruction. Am J Surg Pathol. 2003 Feb;27(2):228-35. doi: 10.1097/00000478-200302000-00012.
•   The burden of gasterointestinal diseases
  In: American Gastroenterological Association; 2001; Bethesda, MD; 2001.
•   Thompson WG
  The functional gasterointestinal bowel disorders. In: Drossman DA, editor. The functional gaterointestinal disorders. Boston: Little, Brown; 1994. p. pp-117-134.
•   Torihashi S, Ward SM, Nishikawa S, Nishi K, Kobayashi S, Sanders KM
  c-kit-dependent development of interstitial cells and electrical activity in the murine gastrointestinal tract. Cell Tissue Res. 1995 Apr;280(1):97-111. doi: 10.1007/BF00304515.
•   Vanderwinden JM, Liu H, De Laet MH, Vanderhaeghen JJ
  Study of the interstitial cells of Cajal in infantile hypertrophic pyloric stenosis. Gastroenterology. 1996 Aug;111(2):279-88. doi: 10.1053/gast.1996.v111.pm8690192. Erratum In: Gastroenterology 1996 Nov;111(5):1403.

Evaluation of the Efficacy and Safety of Rifaximin in Combination With N-acetylcysteine (NAC) in Adult Patients With Irritable Bowel Syndrome With Diarrhea

Details for clinical trial NCT04557215