Mesalazine Treatment in IBS (The MIBS Study)

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

Conditions

• Irritable Bowel Syndrome

Interventions

DRUG

Mesalazine

2400 mg q.d. for 8 weeks

DRUG

Placebo

3 tablets q.d. for 8 weeks

Sponsors & Collaborators

• Sahlgrenska University Hospital

  collaborator OTHER

• Smerud Medical Research International AS

  collaborator OTHER

• Alimenta AB

  collaborator UNKNOWN

• Tillotts Pharma AG

  collaborator INDUSTRY

• Karolinska University Hospital

  collaborator OTHER

• Haukeland University Hospital

  collaborator OTHER

• Oslo University Hospital

  collaborator OTHER

• Sykehuset Innlandet HF

  collaborator OTHER

• Hans Törnblom

  lead OTHER

Principal Investigators

• Hans Törnblom, MD, PhD · Sahlgrenska University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-04-30

Primary Completion

2016-12-31

Completion

2017-02-28

Countries

• Sweden

Study Locations