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Irritable Bowel SyndromePhase 2MIBSNCT01699438

Mesalazine Treatment in IBS (The MIBS Study)

A Phase 2 study testing Mesalazine in people with Irritable Bowel Syndrome, run by Hans Törnblom at 3 sites in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Irritable Bowel Syndrome
What is being tested?
Mesalazine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
211 participants
Where
3 sitesSweden
Study dates
Apr 2012to Feb 2017
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
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  • 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.

Trial locations and contacts

3 sites in 1 country.

Sweden3 sites

  • Sahlgrenska University Hospital

    Gothenburg

  • Karolinska University Hospital

    Huddinge

  • Norrland's University Hospital

    Umeå

Other trials in Sweden

About this study

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.

Read more

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
Being tested
Mesalazine, Placebo
Keywords
Irritable Bowel Syndrome, Inflammation, Mesalazine
Medical subject headings
Irritable Bowel Syndrome, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MesalazineDrug

    Also called Asacol

    2400 mg q.d. for 8 weeks

  • PlaceboDrug

    3 tablets q.d. for 8 weeks

Study groups in NCT01699438
Study groupRoleWhat they receive
MesalazineExperimentalNot described
Receives: Drug: Mesalazine
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Global Irritable Bowel Syndrome (IBS) symptoms

    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)

    Measured: 8 weeks

Secondary outcomes (6)

  1. Inflammatory mediators

    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).

    Measured: 8 weeks

  2. Effect on immune cells and cytokines in mucosal biopsies

    Counts per high-power field in microscopy and by immunohistochemistry

    Measured: 8 weeks

  3. Levels of calprotectin in faeces

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

    Measured: 8 weeks

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

    Absolute change in IBS-SSS compared to baseline.

    Measured: 8 weeks

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

    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.

    Measured: 8 weeks

  6. Exploratory responder variables

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

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Oct 2012 (estimated)
  2. Study startApr 2012
  3. Primary completionDec 2016
  4. Study completionFeb 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
211 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01699438
Sponsor's protocol ID
SMR-2268
Acronym
MIBS
Status last verified
Feb 2017
First submitted
16 Sep 2012
Last updated
24 Feb 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Mesalazine in people with Irritable Bowel Syndrome, run by Hans Törnblom at 3 sites in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Global Irritable Bowel Syndrome (IBS) symptoms (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01699438.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2017.

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