The Effect of Long-Acting Mesalamine on Post-Infective Irritable Bowel Syndrome- A Pilot Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effect of Long-Acting Mesalamine on Post-Infective Irritable Bowel Syndrome- A Pilot Study

Conditions
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Irritable Bowel Syndrome

Intervention / Treatment
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* Drug: Mesalamine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inclusion Criteria Men and women age 18-75 years Rome III criteria for IBS Symptom onset after apparent acute gastroenteritis Symptoms of 6 months or greater duration Normal gross appearance of the colonic mucosa other than erythema Negative markers for celiac disease and inflammatory bowel disease Normal thyroid function and serum calcium Stable medication regimens for other medical conditions. Exclusion Criteria: Age <18 or >75 years Previous diagnosis of or history compatible with IBS Constipation-predominant IBS. Clinically significant chronic cardiac, pulmonary, hepatic, renal dysfunction or HIV History of/or presence of malignancy Current evidence of any gastrointestinal disorder such as celiac disease, inflammatory bowel disease, chronic pancreatitis, scleroderma, HIV, small bowel or colonic resection, paraplegia or quadriplegia. . Current evidence of drug or alcohol abuse as judged by the investigator Allergy to mesalamine or aspirin Investigator perception of patient's inability to comply with the study protocol Unstable psychiatric disease Recent change in gastrointestinal medications

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Placebo<br>This arm will include those who are randomized to the placebo | Drug: Placebo<br>* This is an inactive pill<br>* Other names: Inactive drug;|
| Experimental: Mesalamine<br>This arm is for subjects randomized to the study drug, Mesalamine | Drug: Mesalamine<br>* 2 1.2g tablets once daily for 8 weeks. Patients randomized 50/50 to either Mesalamine or the Placebo<br>* Other names: Lialda;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | Baseline and 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Irritable Bowel Syndrome, Diarrhea, Mesalamine, Gastroenteritis, abdominal pain, hypersensitivity