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

Primary Purpose

Irritable Bowel Syndrome

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Mesalamine
Placebo
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring Irritable Bowel Syndrome, Diarrhea, Mesalamine, Gastroenteritis, abdominal pain, hypersensitivity

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Utah

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Placebo

Mesalamine

Arm Description

This arm will include those who are randomized to the placebo

This arm is for subjects randomized to the study drug, Mesalamine

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Change in Average Bowel Frequency After 8-Week Treatment Period
Measured by the participant reported average number of daily bowel movements.
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.
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.
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.

Full Information

First Posted
June 24, 2011
Last Updated
December 7, 2020
Sponsor
University of Utah
Collaborators
Shire Human Genetic Therapies, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01412372
Brief Title
The Effect of Long-Acting Mesalamine on Post-Infective Irritable Bowel Syndrome- A Pilot Study
Acronym
Mesalamine
Official Title
The Effect of Long-Acting Mesalamine on Post-Infective Irritable Bowel Syndrome- A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
April 22, 2019 (Actual)
Study Completion Date
April 22, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah
Collaborators
Shire Human Genetic Therapies, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
Irritable Bowel Syndrome, Diarrhea, Mesalamine, Gastroenteritis, abdominal pain, hypersensitivity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Experimental
Arm Description
This arm will include those who are randomized to the placebo
Arm Title
Mesalamine
Arm Type
Experimental
Arm Description
This arm is for subjects randomized to the study drug, Mesalamine
Intervention Type
Drug
Intervention Name(s)
Mesalamine
Other Intervention Name(s)
Lialda
Intervention Description
2 1.2g tablets once daily for 8 weeks. Patients randomized 50/50 to either Mesalamine or the Placebo
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Inactive drug
Intervention Description
This is an inactive pill
Primary Outcome Measure Information:
Title
Change in Average Overall Bowel Symptom Score (BSS) After an 8 Week Treatment Period
Description
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
Secondary Outcome Measure Information:
Title
Change in Average Overall IBS Specific Quality of Life Score After an 8 Week Treatment Period.
Description
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
Title
Change in Average Bowel Frequency After 8-Week Treatment Period
Description
Measured by the participant reported average number of daily bowel movements.
Time Frame
Baseline and 8 weeks
Title
Change in Average Bowel Consistency Score After an 8 Week Treatment Period.
Description
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
Title
Change in Average Abdominal Pain Score After an 8 Week Treatment Period
Description
Measured on a scale of 0% to 100%, 0 being not severe and 100 being very severe.
Time Frame
Baseline and 8 weeks
Title
Change in Average Bloating Score After an 8 Week Treatment Period.
Description
Measured on a scale of 0% to 100%, 0 being not severe and 100 being very severe.
Time Frame
Baseline and 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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 <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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashok Tuteja
Organizational Affiliation
Gastroenterology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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