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Completed

NCT Number: NCT01699438

Mesalazine Treatment in IBS (The MIBS Study)

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

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Inflammation Intestinal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sahlgrenska University Hospital, Gothenburg, Sweden

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males and females aged 18 to 70 years, both inclusive
  • Subject is diagnosed with irritable bowel syndrome (IBS) prior to Screening based on the Rome III diagnostic criteria.
  • Subject presents with IBS 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)
  • Provision of signed informed consent

Exclusion criteria

  • Subjects who are unable to understand the written and verbal instructions
  • Presence of a systemic inflammatory disease
  • Presence of other gastrointestinal diseases likely to explain the IBS symptoms
  • Presence of other severe somatic disease
  • Treatment with non-steroidal anti-inflammatory drugs (NSAID), opioid analgetics or acetylsalicylic acid (ASA) compounds within 7 days prior to screening (Visit 1, Day -21±2)
  • Treatment with systemic antibiotics within 28 days prior to Screening (Visit 1, Day -21±2)
  • Treatment with immunosuppressant drugs within 28 days prior to Screening (Visit 1, Day -21±2)
  • Other significant medical treatment, which, in the opinion of the investigator, may compromise the safety and efficacy objectives of the study, within 28 days prior to Screening (Visit 1, Day -21±2)
  • Previously confirmed allergy towards ASA or mesalazine
  • Presence of renal disease and/or concomitant treatment with medications with potential renal side effects
  • Current ongoing infection
  • History of, or current, drug or alcohol dependence
  • Pregnant or lactating women
  • Subjects suspected not to follow instructions based on the discretion of the Investigator
  • Current participation in other intervention studies
  • Female subjects of childbearing potential unwilling to use adequate contraceptive measures throughout the duration of the study.

Treatment and study plan

Mesalazine

Drug

2400 mg q.d. for 8 weeks

Other names: Asacol

Placebo

Drug

3 tablets q.d. for 8 weeks

Primary outcomes

  1. Global Irritable Bowel Syndrome (IBS) symptoms

    Time frame: 8 weeks

    The main measurement parameter of symptom alleviation will be a weekly question regarding satisfactory relief of global IBS symptoms. A treatment responder will be defined as answering "yes" ≥50% of the weeks (≥4 weeks)

Secondary outcomes

  1. Inflammatory mediators

    Time frame: 8 weeks

    Measured by the Mucosal Patch Technology (MPT), e.g. neutrophil mediators (myeloperoxidase (MPO)), eosinophilic mediators (eosinophil cationic protein (ECP)), mast cell activity mediators (tryptase) and cytokines (Interleukin (IL)-2, IL-6, Tumor necrosis factor (TNF)-alpha, IL-1beta etc) by Enzyme-Linked Immunosorbent Assays (ELISA), (ug/ml).

  2. Effect on immune cells and cytokines in mucosal biopsies

    Time frame: 8 weeks

    Counts per high-power field in microscopy and by immunohistochemistry

  3. Levels of calprotectin in faeces

    Time frame: 8 weeks

    Enzyme-Linked Immunosorbent Assay (ELISA), mg/kg

  4. Change in total IBS symptom severity score (IBS-SSS)

    Time frame: 8 weeks

    Absolute change in IBS-SSS compared to baseline.

  5. Individual symptom parameters in IBS symptom severity score (IBS-SSS) and the IBS diary

    Time frame: 8 weeks

    Reduction of scores regarding individual question components (visual analog scale (VAS)) in IBS-SSS. Stool frequency and consistency expressed by Bristol Stool Form Scale in a separate IBS diary.

  6. Exploratory responder variables

    Time frame: 8 weeks

    • Satisfactory symptom relief ≥75% of the time
    • Reduction in IBS-SSS ≥50 at end of treatment compared to baseline

Sponsors and collaborators

Lead sponsor

Hans Törnblom

Other

Collaborators

  • Alimenta AB
  • Haukeland University Hospital
  • Karolinska University Hospital
  • Oslo University Hospital
  • Sahlgrenska University Hospital
  • Smerud Medical Research International AS
  • Sykehuset Innlandet HF
  • Tillotts Pharma AG

Registry information

Official study title

Mesalazine Treatment in IBS, a Double-blind Placebo-controlled Phase II Intervention Study in Adult Patients

Acronym: MIBS

Important dates

Study start
2012
Primary completion
2016
Study completion
2017
First posted
Oct 3, 2012
Registry last updated
Feb 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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