The purpose of the trial is to define the clinical benefit and possible mediators of the benefit of mesalazine in Irritable Bowel Syndrome (IBS) with diarrhoea. The investigators will therefore evaluate symptoms (primarily bowel frequency) and markers reflecting mast cell activation and small bowel tone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
108
2g oral granules, once a day for 1 week, then 2g oral granules, twice a day for 11 weeks
2g oral granules, once a day for 1 week, then 2g oral granules, twice a day for 11 weeks
Queen's Medical Centre
Nottingham, Notts, United Kingdom
Change from baseline in average stool frequency during weeks 11 and 12.
Clinical Endpoint
Time frame: Week 0 and week 12
Change from baseline of number of mast cell per mm2 at week 12
Mechanistic endpoint
Time frame: Week 0 and week 12
Average daily severity of abdominal pain on a 0-10 scale
Clinical Endpoint
Time frame: Week 0 to week 12
Days with urgency
Clinical Endpoint
Time frame: weeks 11-12
Mean stool consistency using Bristol Stool Form Score
Clinical Endpoint
Time frame: Week 0 to week 12
Global satisfaction with control of IBS symptoms
as assessed from the answer to the question "Have you had satisfactory relief of your IBS symptoms this week? Yes / No. "
Time frame: Week 0 to week 12
Mast cell tryptase release during 6 hour biopsy incubation
Mechanistic endpoint
Time frame: Week 0 and week 12
IL-1β, TNF-a, histamine and serotonin secretion during same incubation
Mechanistic endpoint
Time frame: Week 0 and week 12
Small bowel tone assessed by volume of fasting small bowel water
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Mechanistic endpoint
Time frame: Week 0 and week 12
Euro-Qol Score
Ancillary endpoint
Time frame: Week 0 and week 12
Centres for disease control and prevention health related quality of life healthy days core module score
Ancillary endpoint
Time frame: Week 0 and week 12
Hospital Anxiety Depression Scale Score
Ancillary endpoint
Time frame: Week 0 and week 12
Patient Health Questionnaire -15
Ancillary endpoint
Time frame: Week 0 and week 12