Clinical trial NCT01412372: The Effect of Long-Acting Mesalamine on Post-Infective Irritable Bowel Syndrome- A Pilot Study
Official title: The Effect of Long-Acting Mesalamine on Post-Infective Irritable Bowel Syndrome- A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Irritable Bowel Syndrome
Keywords: Irritable Bowel Syndrome
Diarrhea
Mesalamine
Gastroenteritis
abdominal pain
hypersensitivity
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: Shire Human Genetic Therapies, Inc.
First posted: 2011-08-09
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

Inclusion Criteria

1. Men and women age 18-75 years
2. Rome III criteria for IBS
3. Symptom onset after apparent acute gastroenteritis
4. Symptoms of 6 months or greater duration
5. Normal gross appearance of the colonic mucosa other than erythema
6. Negative markers for celiac disease and inflammatory bowel disease
7. Normal thyroid function and serum calcium
8. Stable medication regimens for other medical conditions.

Exclusion Criteria:

1. Age \<18 or \>75 years
2. Previous diagnosis of or history compatible with IBS
3. Constipation-predominant IBS.
4. Clinically significant chronic cardiac, pulmonary, hepatic, renal dysfunction or HIV
5. History of/or presence of malignancy
6. 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. .
7. Current evidence of drug or alcohol abuse as judged by the investigator
8. Allergy to mesalamine or aspirin
9. Investigator perception of patient's inability to comply with the study protocol
10. Unstable psychiatric disease
11. Recent change in gastrointestinal medications

Primary outcomes:
measure: Change in Average Overall Bowel Symptom Score (BSS) After an 8 Week Treatment Period
timeFrame: Baseline and 8 weeks
Secondary outcomes:
measure: Change in Average Overall IBS Specific Quality of Life Score After an 8 Week Treatment Period.
timeFrame: Baseline and 8 weeks
measure: Change in Average Bowel Frequency After 8-Week Treatment Period
timeFrame: Baseline and 8 weeks
measure: Change in Average Bowel Consistency Score After an 8 Week Treatment Period.
timeFrame: Baseline and 8 weeks
measure: Change in Average Abdominal Pain Score After an 8 Week Treatment Period
timeFrame: Baseline and 8 weeks
measure: Change in Average Bloating Score After an 8 Week Treatment Period.
timeFrame: Baseline and 8 weeks
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: Gastroenterology
name: Ashok Tuteja
role: PRINCIPAL_INVESTIGATOR
References: