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

Irritable Bowel Syndrome Clinical Trial

— Mesalamine  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01412372
• Other study ID #: 39402
• Status: Completed
• Phase: Phase 3
• Start date: June 2010
• Est. completion date: April 22, 2019

Study information

• Verified date: December 2020
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: April 22, 2019
• Est. primary completion date: April 22, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

Drug:
• Mesalamine
2 1.2g tablets once daily for 8 weeks. Patients randomized 50/50 to either Mesalamine or the Placebo
• Placebo
This is an inactive pill

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
University of Utah	Shire Human Genetic Therapies, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline and 8 weeks
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.	Baseline and 8 weeks
Secondary	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
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.	Baseline and 8 weeks
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.	Baseline and 8 weeks
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.	Baseline and 8 weeks