The purpose of this study is to evaluate the effects of long acting mesalamine (Lialda) in patients with Post-Infective Irritable Bowel Syndrome (PI-IBS). The investigators will evaluate gastrointestinal symptoms, IBS specific quality of life (IBS-QOL), and plasma cytokines before and after treatment with Lialda.
This study will test long acting mesalamine in the management of PI-IBS. It has the potential to improve QOL and perhaps gastrointestinal symptoms, in patients with PI-IBS. The results of this study, if positive, will provide preliminary data for a large scale clinical trial. This study will also provide information about plasma cytokines in patients with PI-IBS and whether improvement in symptoms correlates with improvement in plasma cytokines.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
61
2 1.2g tablets once daily for 8 weeks. Patients randomized 50/50 to either Mesalamine or the Placebo
This is an inactive pill
University of Utah
Salt Lake City, Utah, United States
Change in Average Overall Bowel Symptom Score (BSS) After an 8 Week Treatment Period
BSS score measured from sum of BSS items of abdominal pain severity, bloating severity, diarrhea severity, constipation severity, and how satisfied are you with bowel habits, and measured on a scale of 0% to 100%, 0 being not severe and 100 being very severe.
Time frame: Baseline and 8 weeks
Change in Average Overall IBS Specific Quality of Life Score After an 8 Week Treatment Period.
As measured by the IBS specific Quality of Life questionnaire which consists of 34 items scored on a scale of 0% to 100%, 0 being not at all and 100 being extremely.
Time frame: Baseline and 8 weeks
Change in Average Bowel Frequency After 8-Week Treatment Period
Measured by the participant reported average number of daily bowel movements.
Time frame: Baseline and 8 weeks
Change in Average Bowel Consistency Score After an 8 Week Treatment Period.
Measured using the Bristol Stool form scale 1-7, with 1 being the most formed and 7 the least formed.
Time frame: Baseline and 8 weeks
Change in Average Abdominal Pain Score After an 8 Week Treatment Period
Measured on a scale of 0% to 100%, 0 being not severe and 100 being very severe.
Time frame: Baseline and 8 weeks
Change in Average Bloating Score After an 8 Week Treatment Period.
Measured on a scale of 0% to 100%, 0 being not severe and 100 being very severe.
Time frame: Baseline and 8 weeks
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