Ciprofloxacin and probiotic Escherichia coli Nissle add-on treatment in active ulcerative colitis: A double-blind randomized placebo controlled clinical trial |
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| Institution: | 1. Department of Gastroenterology, Hvidovre University Hospital, Copenhagen, Denmark;2. Department of Clinical Microbiology, Hvidovre University Hospital, Copenhagen, Denmark;3. Department of Microbiology and Infection Control, Statens Serum Institut, Copenhagen, Denmark;1. IBD Center, Gastroenterology, Humanitas Research Hospital, Rozzano, Milan, Italy;2. IBD Center, Gastroenterology, La Source-Beaulieu, Lausanne, Switzerland;1. Department of Gastroenterology and Hepatology, University Hospital Basel, Basel, Switzerland;2. University of Applied Sciences Northwestern Switzerland (FHNW), Institute of Chemistry and Bioanalytics, Muttenz, Switzerland;1. Department of Gastroenterology, Sheba Medical Center, Sackler School of Medicine, Tel-Aviv University, Tel-Hashomer, Israel;2. Coagulation Unit, Hematology Department, Sheba Medical Center, Sackler School of Medicine, Tel-Aviv University, Tel-Hashomer, Israel;3. Radiology Department, Sheba Medical Center, Sackler School of Medicine, Tel-Aviv University, Tel-Hashomer, Israel;1. Digestive Disease Centre, Medical Section, Herlev University Hospital, Copenhagen, Denmark;2. 1st Department of Medicine, Semmelweis University, Budapest, Hungary;3. Nicosia Private Practice, Cyprus;4. IBD Centre ISCARE, Charles University, Prague, Czech Republic;5. Department of Medicine, Amager Hospital, Amager, Denmark;6. Medical Department, The National Hospital of the Faroe Islands, Torshavn, Faroe Islands;7. 1st Division of Internal Medicine and Division of Gastroenterology, Faculty of Medicine, University of Ioannina, Ioannina, Greece;8. Department of Gastroenterology and Hepatology, Soroka Medical Centre and Ben-Gurion University of the Negev, Beer Sheva, Israel;9. U.O.Gastroenterologia ed Endoscopia, Ospedale Maggiore di Crema, Crema, Italy;10. On behalf of the EpiCom Northern Italy centre based in Crema, Cremona, Firenze, Forlì & Padova and Reggio Emilia, Italy;11. U.O. Gastroenterologia ed Endoscopia Digestiva, University of Ioannina, Forlì, Italy;12. Institute for Digestive Research, Lithuanian University of Health Sciences, Kaunas, Lithuania;13. Department of Gastroenterology, State University of Medicine and Pharmacy, Chisinau, Republic of Moldova;14. Department of Paediatric Gastroenterology, Centre of Mother and Child, Chisinau, Republic of Moldova;15. Hospital de Vale de Sousa, Porto, Portugal;p. Department of Gastroenterology, Hospital de São João, Porto, Portugal;q. Department of Pharmacology and Therapeutics, Oporto Medical School, Porto, Portugal;r. MedInUP—Centre for Drug Discovery and Innovative Medicines, University of Porto, Porto, Portugal;s. Clinic of Gastroenterology, University of Medicine ‘Victor Babes’, Timisoara, Romania;t. Gastroenterology Department, POVISA Hospital, Vigo, Spain;u. Gastroenterology Department, Complexo Hospitalario Universitario de Vigo, Vigo, Spain;v. Department of Gastroenterology, St Vincent''s Hospital, Melbourne, Victoria, Australia;w. Department of Medical Gastroenterology, Gentofte Hospital, Copenhagen, Denmark;1. Department of Medicine II, University Hospital Munich-Grosshadern, Ludwig-Maximilians-University Munich, Germany;2. Internal Practice, Leipzig, Germany;3. Internal Practice, Hamburg, Germany;4. Department of Medicine II, Saarland University Medical Center, Homburg, Germany;5. Department for Gastroenterology, Infectious Diseases and Rheumatology Charité-Berlin, Campus Benjamin Franklin, Berlin, Germany;6. Department of Medicine II, Krankenhaus Barmherzige Brüder, Munich, Germany;7. Isarmedizin Zentrum, Munich, Germany |
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| Abstract: | Background and aimUlcerative colitis (UC) is a chronic inflammatory bowel disease. The probiotic bacterium Escherichia coli Nissle 1917 (EcN) has been used to maintain and induce clinical remission in UC. Our aim was to test the effect of Ciprofloxacin and/or orally administered EcN as add-on to conventional therapies in patients with active UC.Patients and methodsOur single center double-blinded randomized placebo controlled study included patients with a Colitis Activity Index (CAI) score of at least 6. Patients were randomized to Ciprofloxacin or placebo for 1 week followed by EcN or placebo for 7 weeks. All 4 treatments were given as add-on treatments.ResultsOne hundred subjects with active UC were recruited. In the per-protocol analysis we, surprisingly, found that in the group receiving placebo/EcN fewer patients, 54%, reached remission compared to the group receiving placebo/placebo, 89%, p < 0.05. Among patients treated with Cipro/placebo and Cipro/EcN, 78% and 66% reached remission, respectively. Furthermore, the group receiving placebo/EcN had the largest number of withdrawals, 11 of 25 (44%), compared to 15 of 75 (20%) in any of the other groups, p < 0.05. Indication of lack of mucosal healing was found in the group treated with placebo/Nissle, since only 4 (29%) of the 14 patients, who completed the study, reported no blood in stools at week 12 (p < 0.02), compared to 63%, 67% and 65% in groups treated with Cipro/Nissle, Cipro/placebo and placebo/placebo, respectively.ConclusionsOur data suggest that there is no benefit in the use of E. coli Nissle as an add-on treatment to conventional therapies for active ulcerative colitis. Furthermore, treatment with E. coli Nissle without a previous antibiotic cure resulted in fewer patients reaching clinical remission. |
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