Phase 3
N=61
The Effect of Long-Acting Mesalamine on Post-Infective Irritable Bowel Syndrome- A Pilot Study
Irritable Bowel Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT01412372 ↗Enrolled (actual)
61
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcome: Primary: Change in Average Overall Bowel Symptom Score (BSS) After an 8 Week Treatment Period — -4; -13 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Mesalamine (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Utah
- Primary completion
- Apr 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Average Overall Bowel Symptom Score (BSS) After an 8 Week Treatment Period |
-4; -13 | — |
| SECONDARY Change in Average Overall IBS Specific Quality of Life Score After an 8 Week Treatment Period. |
4; 8 | — |
| SECONDARY Change in Average Bowel Frequency After 8-Week Treatment Period |
0.0; -0.9 | — |
| SECONDARY Change in Average Bowel Consistency Score After an 8 Week Treatment Period. |
-0.5; -0.8 | — |
| SECONDARY Change in Average Abdominal Pain Score After an 8 Week Treatment Period |
-5; -9 | — |
| SECONDARY Change in Average Bloating Score After an 8 Week Treatment Period. |
-4; -8 | — |
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.
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT01412372). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.