Mesalazine Treatment in IBS (The MIBS Study)
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      Irritable bowel syndrome (IBS) is a condition characterised by abdominal pain or discomfort
      in combination with altered bowel function (stool frequency and/or stool consistency),
      currently defined by the Rome III criteria. The current IBS definition specifies that there
      are no structural or biochemical abnormalities to account for the symptoms but there is
      growing evidence that in at least a subset of IBS patients, a discrete immune activation
      might be a key pathogenetic factor. The condition is prone to develop after a
      gastroenteritis, post-infectious IBS, and increased numbers of lymphocytes, mast cells and
      pro-inflammatory cytokines like Interleukin (IL)-1β, IL-6, Tumor necrosis factor (TNF)-α and
      a general increase in mucosal cellularity have been reported. Despite this, the efficacy of
      anti-inflammatory agents has been poorly investigated.

      This will be a randomised, double blind, placebo-controlled, parallel-group, multi-centre
      study that aims to include a total of 200 subjects with irritable bowel syndrome (IBS). All
      subjects will be randomised to receive either 3x800 mg of mesalazine (Asacol®) or
      corresponding placebo once daily for a total treatment duration of 8 weeks. Males and females
      aged 18 to 70 years who already are diagnosed with IBS based on the Rome III diagnostic
      criteria and with a symptom intensity of at least moderate level; defined as an IBS Severity
      Scoring System (IBS-SSS) score of ≥175 at both Screening (Visit 1, Day -21±2) and Baseline
      (Visit 2, Day 0) will be eligible to enter the study.

      Primary aim:

      To assess the effect of mesalazine (Asacol®) treatment compared to placebo on global IBS
      symptoms: A treatment responder will be defined by answering the satisfactory relief of
      IBS-symptoms question "yes" at the end of at least 4 out of of 8 treatment weeks.

      Secondary aims:

      To assess mesalazine (Asacol®) treatment compared to placebo regarding:

        1. Levels of inflammatory mediators in the rectal mucosa (e.g. neutrophil mediators,
           eosinophilic mediators, mast cell activity mediators and cytokines) measured by a new
           diagnostic tool, the Mucosal Patch Technology (MPT) by means of Enzyme-Linked
           Immunosorbent Assays (ELISA)

        2. Effects on number of immune cells (count per high power field) and cytokine content
           (immunohistochemistry) in mucosal biopsies

        3. Calprotectin levels in faeces (mg/kg)

        4. Individual IBS symptom parameters derived from a symptom diary and also measured by
           IBS-SSS
    


Intervention name(s): Mesalazine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 2400 mg q.d. for 8 weeks; 3 tablets q.d. for 8 weeks
Other intervention name(s): Asacol
Intervention MeSH terms: Mesalamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Irritable Bowel Syndrome; Inflammation; Mesalazine