Irritable Bowel Syndrome
Conditions
Keywords
Irritable Bowel Syndrome, Diarrhea, Mesalamine, Gastroenteritis, abdominal pain, hypersensitivity
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.
Interventions
DRUGMesalamine
2 1.2g tablets once daily for 8 weeks. Patients randomized 50/50 to either Mesalamine or the Placebo
DRUGPlacebo
This is an inactive pill
Sponsors
Shire Human Genetic Therapies, Inc.
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Average Overall Bowel Symptom Score (BSS) After an 8 Week Treatment Period | Baseline and 8 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Average Overall IBS Specific Quality of Life Score After an 8 Week Treatment Period. | Baseline and 8 weeks | 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. |
| Change in Average Bowel Frequency After 8-Week Treatment Period | Baseline and 8 weeks | Measured by the participant reported average number of daily bowel movements. |
| Change in Average Bowel Consistency Score After an 8 Week Treatment Period. | Baseline and 8 weeks | Measured using the Bristol Stool form scale 1-7, with 1 being the most formed and 7 the least formed. |
| Change in Average Abdominal Pain Score After an 8 Week Treatment Period | Baseline and 8 weeks | Measured on a scale of 0% to 100%, 0 being not severe and 100 being very severe. |
| Change in Average Bloating Score After an 8 Week Treatment Period. | Baseline and 8 weeks | Measured on a scale of 0% to 100%, 0 being not severe and 100 being very severe. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo This arm will include those who are randomized to the placebo
Placebo: This is an inactive pill | 30 |
| Mesalamine This arm is for subjects randomized to the study drug, Mesalamine
Mesalamine: 2 1.2g tablets once daily for 8 weeks. Patients randomized 50/50 to either Mesalamine or the Placebo | 31 |
| Total | 61 |
Baseline characteristics
| Characteristic | Mesalamine | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 40 years STANDARD_DEVIATION 12 | 43 years STANDARD_DEVIATION 13 | 46 years STANDARD_DEVIATION 13 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 31 Participants | 61 Participants | 30 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 29 Participants | 59 Participants | 30 Participants |
| Sex: Female, Male Female | 5 Participants | 6 Participants | 1 Participants |
| Sex: Female, Male Male | 26 Participants | 55 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 31 |
| other Total, other adverse events | 10 / 30 | 16 / 31 |
| serious Total, serious adverse events | 0 / 30 | 0 / 31 |
Outcome results
Primary
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
Population: Not all study participants provided complete outcome results at baseline and 8 weeks. For change in overall BSS, only 25 placebo participants and 28 mesalamine participants provided data for analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Average Overall Bowel Symptom Score (BSS) After an 8 Week Treatment Period | -4 score on a scale | Standard Error 3 |
| Mesalamine | Change in Average Overall Bowel Symptom Score (BSS) After an 8 Week Treatment Period | -13 score on a scale | Standard Error 3 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Average Abdominal Pain Score After an 8 Week Treatment Period | -5 score on a scale | Standard Error 6 |
| Mesalamine | Change in Average Abdominal Pain Score After an 8 Week Treatment Period | -9 score on a scale | Standard Error 4 |
Secondary
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
Population: Not all study participants provided complete outcome results at baseline and 8 weeks. For change in average bloating, only 25 placebo participants and 28 mesalamine participants provided data for analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Average Bloating Score After an 8 Week Treatment Period. | -4 score on a scale | Standard Error 4 |
| Mesalamine | Change in Average Bloating Score After an 8 Week Treatment Period. | -8 score on a scale | Standard Error 6 |
Secondary
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
Population: Not all study participants provided complete outcome results at baseline and 8 weeks. For change in average bowel consistency, only 26 placebo participants and 26 mesalamine participants provided data for analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Average Bowel Consistency Score After an 8 Week Treatment Period. | -0.5 score on a scale | Standard Error 0.2 |
| Mesalamine | Change in Average Bowel Consistency Score After an 8 Week Treatment Period. | -0.8 score on a scale | Standard Error 0.3 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Average Bowel Frequency After 8-Week Treatment Period | 0.0 Bowel movements per day | Standard Error 0.5 |
| Mesalamine | Change in Average Bowel Frequency After 8-Week Treatment Period | -0.9 Bowel movements per day | Standard Error 0.3 |
Secondary
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
Population: Not all study participants provided complete outcome results at baseline and 8 weeks. For change in average overall IBS specific Quality of Life, only 25 placebo participants and 28 mesalamine participants provided data for analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Average Overall IBS Specific Quality of Life Score After an 8 Week Treatment Period. | 4 score on a scale | Standard Error 4 |
| Mesalamine | Change in Average Overall IBS Specific Quality of Life Score After an 8 Week Treatment Period. | 8 score on a scale | Standard Error 4 |