title: A double-blind, placebo-controlled study to assess the effect of a probiotic mixture on symptoms and inflammatory markers in women with diarrhea-predominant IBS.
abstract: BACKGROUND
  Micro-inflammation is considered an element in the pathogenesis of irritable bowel syndrome (IBS). High-sensitivity C reactive protein (hs-CRP) was previously shown to be higher in IBS compared to healthy controls, albeit within the normal range. Since probiotics may suppress micro-inflammation in the gut, we tested if they reduce symptoms and inflammatory markers (hs-CRP and fecal calprotectin (FC) in diarrhea-predominant IBS (IBS-D). The aim of this study was to assess the clinical and laboratory effects of BIO-25, a multispecies probiotic, in women with IBS-D.
  
  
  METHODS
  A double-blind, placebo-controlled study. Following a 2-week run-in, eligible women were assigned at random to a probiotic capsule or an indistinguishable placebo, twice daily for 8 weeks. IBS symptoms and stool consistency were rated daily by Visual Analogue Scales (VAS) and the Bristol Stool Scale (BSS). High-sensitivity C reactive protein was tested at baseline, 4 and 8 weeks. FC was tested at baseline and 8 weeks.
  
  
  RESULTS
  One hundred and seventy-two IBS-D patients were recruited and 107 eligible patients were allocated to the intervention (n=54) or placebo (n=53) group. All symptoms improved in both groups with no significant difference between them in symptom improvement, hs-CRP or FC levels.
  
  
  CONCLUSIONS
  An 8-week treatment with BIO-25 improved symptoms in women with IBS-D, but was not superior to placebo. This rigorously designed and executed study supports the findings of other studies that did not demonstrate superiority of probiotics over placebo in IBS. High quality clinical studies are necessary to examine the efficacy of other specific probiotics in IBS-D patients since data are still conflicting.
authors.affiliation: Department of Epidemiology and Preventive Medicine, School of Public Health, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.|Research Division, Epidemiology Service, Assuta Medical Centers, Tel Aviv, Israel.
authors.forename: K
authors.identifier: http://orcid.org/0000-0002-8115-7274
authors.initials: K
authors.lastname: Hod
authors.affiliation: Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel.
authors.forename: A D
authors.initials: AD
authors.lastname: Sperber
authors.affiliation: Department of Gastroenterology and Liver Diseases, Tel-Aviv Sourasky Medical Center, Affiliated to the Sackler Faculty of Medicine, Tel Aviv, Israel.
authors.forename: Y
authors.initials: Y
authors.lastname: Ron
authors.affiliation: Department of Nutrition Sciences, School of Health Sciences, Ariel University, Ariel, Israel.
authors.forename: M
authors.initials: M
authors.lastname: Boaz
authors.affiliation: Department of Gastroenterology and Liver Diseases, Rabin Medical Center, Belinson Hospital, Petach Tikva, Israel.
authors.forename: R
authors.initials: R
authors.lastname: Dickman
authors.affiliation: Department of Medicine E, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.
authors.forename: S
authors.initials: S
authors.lastname: Berliner
authors.affiliation: Department of Gastroenterology and Liver Diseases, Tel-Aviv Sourasky Medical Center, Affiliated to the Sackler Faculty of Medicine, Tel Aviv, Israel.
authors.forename: Z
authors.initials: Z
authors.lastname: Halpern
authors.affiliation: Department of Gastroenterology and Liver Diseases, Tel-Aviv Sourasky Medical Center, Affiliated to the Sackler Faculty of Medicine, Tel Aviv, Israel.
authors.forename: N
authors.initials: N
authors.lastname: Maharshak
authors.affiliation: Department of Gastroenterology and Liver Diseases, Tel-Aviv Sourasky Medical Center, Affiliated to the Sackler Faculty of Medicine, Tel Aviv, Israel.
authors.forename: R
authors.initials: R
authors.lastname: Dekel
mesh_terms: D000328:Adult; D015415:Biomarkers / Q000378:metabolism; D003967:Diarrhea / Q000178:diet therapy* / Q000378:metabolism* / Q000503:physiopathology; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D018836:Inflammation Mediators / Q000037:antagonists & inhibitors / Q000378:metabolism*; D043183:Irritable Bowel Syndrome / Q000178:diet therapy* / Q000378:metabolism* / Q000503:physiopathology; D008875:Middle Aged; D015990:Placebo Effect; D019936:Probiotics / Q000008:administration & dosage*; D011446:Prospective Studies; D016896:Treatment Outcome
chemical_list: D015415:Biomarkers; D018836:Inflammation Mediators
keywords: calprotectin; diarrhea; hs-CRP; irritable bowel syndrome; probiotics