Probiotic in Irritable Bowel Syndrome (IBS) Patients With Diarrhea
Condition: IBS
MeSH terms: Diarrhea
Study type: Interventional
Phase: Phase 4

Summary: 
      We present the study design of a clinical trial designed to assess the clinical effects of
      the multispecies probiotic combination "BIO-25" in IBS-D patients. To this aim the primary
      endpoints of the study will be improvement in abdominal pain and stool consistency. The study
      will also be designed and powered to investigate the effect of the probiotic BIO-25 on the
      putative inflammation-associated parameters related to microinflammation in IBS, using
      postulated improvements in Hs-CRP, and calprotectin as markers of that effect. Additional
      aims of the study will examine the possible effect of probiotic BIO-25 on the cholinergic
      status.
    

Detailed description: 
      Probiotic treatment in IBS is safe and effective. Probiotics have been shown to improve the
      anti-inflammatory/proinflammatory ratio, and may also improve intestinal motility, and the
      bacterial composition of the intestines. There is a substantial body of evidence in support
      of the use of probiotics in IBS. Probiotics appear to be particularly effective in the
      reduction of abdominal bloating and discomfort. The strains of the multispecies probiotic
      combination (BIO-25 LR) were tested and found to be beneficial in well-designed studies of
      IBS patients. Patients with post-infectious IBS, as well as many patients with "classic" IBS,
      manifest a low-grade inflammatory state that may be associated with visceral hypersensitivity
      and impaired motility. Probiotics may suppress this low-grade inflammation. In a recent study
      we found that highly sensitive CRP (hs-CRP), a serum marker of micro-inflammation, was
      significantly higher in patients with diarrhea-predominant IBS than healthy controls,
      although within normal limits in both groups. Thus, hs-CRP may serve as a marker of this
      low-grade, sub-clinical inflammation. If treatment with probiotic reduces the degree of
      low-grade inflammation in IBS, the improvement may be reflected in reduced hs-CRP levels.
      This study can contribute to our understanding of the pathophysiology of IBS and provide
      further evidence for the effectiveness of probiotic in its treatment.
    

Intervention name(s): Bio-25; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Each capsule of the multispecies probiotic combination Bio-25 consists of 25 billion live bacteria.
Each type of bio-25 contains billions of live lactic acid bacteria in defined ratios of lyophilized Bifidobacterium breve, Bifidobacterium longum, Bifidobacterium infantis, Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus paracasein, Lactobacillus casei, Bifidobacterium bifidum,Lactobacillus lactis, Lactobacillus rhamnosus,and Streptococcus thermophilus.; Identical placebo
Other intervention name(s): Probiotic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: IBS; Probiotic; hs-CRP; Cholinergic status; Micro-inflammation