Irritable Bowel Syndrome Clinical Trial
Official title:
Mesalazine Treatment in IBS, a Double-blind Placebo-controlled Phase II Intervention Study in Adult Patients
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
n/a
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