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

• Sponsor: University of Utah (Other)
• Overall Status: Completed
• CT.gov ID: NCT01412372
• Collaborator: Shire Human Genetic Therapies, Inc. (Industry)
• Enrollment: 61
• Location: 1
• Arms: 2
• Duration (Months): 106.7
• Patients Per Site Per Month: 0.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Irritable Bowel Syndrome	Drug: Mesalamine; Drug: Placebo	Phase 3

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 61 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: The Effect of Long-Acting Mesalamine on Post-Infective Irritable Bowel Syndrome- A Pilot Study
• Study Start Date: Jun 1, 2010
• Actual Primary Completion Date: Apr 22, 2019
• Actual Study Completion Date: Apr 22, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Placebo This arm will include those who are randomized to the placebo	Drug: Placebo; This is an inactive pill; Other Names: Inactive drug
Experimental: Mesalamine This arm is for subjects randomized to the study drug, Mesalamine	Drug: Mesalamine; 2 1.2g tablets once daily for 8 weeks. Patients randomized 50/50 to either Mesalamine or the Placebo; Other Names: Lialda

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Utah	Salt Lake City	Utah	United States	84132

Sponsors and Collaborators

• University of Utah
• Shire Human Genetic Therapies, Inc.

Investigators

• Principal Investigator: Ashok Tuteja, Gastroenterology

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 14, 2019

More Information

Publications

None provided.

• Responsible Party: Ashok K. Tuteja, Associate professor of medicine, University of Utah
• ClinicalTrials.gov Identifier: NCT01412372
• Other Study ID Numbers: 39402
• First Posted: Aug 9, 2011
• Last Update Posted: Dec 31, 2020
• Last Verified: Dec 1, 2020

• Keywords provided by Ashok K. Tuteja, Associate professor of medicine, University of Utah: Irritable Bowel Syndrome; Diarrhea; Mesalamine; Gastroenteritis; abdominal pain; hypersensitivity
• Additional relevant MeSH terms: Irritable Bowel Syndrome; Syndrome; Mesalamine

Study Results

Participant Flow

Arm/Group Title	Placebo	Mesalamine
Arm/Group Description	This arm will include those who are randomized to the placebo Placebo: This is an inactive pill	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
Period Title: Overall Study
STARTED	30	31
COMPLETED	26	28
NOT COMPLETED	4	3

Baseline Characteristics

Arm/Group Title	Placebo	Mesalamine	Total
Arm/Group Description	This arm will include those who are randomized to the placebo Placebo: This is an inactive pill	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	Total of all reporting groups
Overall Participants	30	31	61
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	46 (13)	40 (12)	43 (13)
Sex: Female, Male (Count of Participants)
Female	1 3.3%	5 16.1%	6 9.8%
Male	29 96.7%	26 83.9%	55 90.2%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%
Not Hispanic or Latino	30 100%	31 100%	61 100%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	2 6.5%	2 3.3%
White	30 100%	29 93.5%	59 96.7%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

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/Group Title	Placebo	Mesalamine
Arm/Group Description	This arm will include those who are randomized to the placebo Placebo: This is an inactive pill	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
Measure Participants	25	28
Mean (Standard Error) [score on a scale]	-4 (3)	-13 (3)

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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/Group Title	Placebo	Mesalamine
Arm/Group Description	This arm will include those who are randomized to the placebo Placebo: This is an inactive pill	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
Measure Participants	25	28
Mean (Standard Error) [score on a scale]	4 (4)	8 (4)

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Mesalamine
Arm/Group Description	This arm will include those who are randomized to the placebo Placebo: This is an inactive pill	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
Measure Participants	26	28
Mean (Standard Error) [Bowel movements per day]	0.0 (0.5)	-0.9 (0.3)

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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/Group Title	Placebo	Mesalamine
Arm/Group Description	This arm will include those who are randomized to the placebo Placebo: This is an inactive pill	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
Measure Participants	26	26
Mean (Standard Error) [score on a scale]	-0.5 (0.2)	-0.8 (0.3)

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Mesalamine
Arm/Group Description	This arm will include those who are randomized to the placebo Placebo: This is an inactive pill	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
Measure Participants	26	28
Mean (Standard Error) [score on a scale]	-5 (6)	-9 (4)

6. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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/Group Title	Placebo	Mesalamine
Arm/Group Description	This arm will include those who are randomized to the placebo Placebo: This is an inactive pill	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
Measure Participants	25	28
Mean (Standard Error) [score on a scale]	-4 (4)	-8 (6)

Adverse Events

Time Frame	8 weeks
Arm/Group Title	Placebo		Mesalamine
Arm/Group Description	This arm will include those who are randomized to the placebo Placebo: This is an inactive pill		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
All Cause Mortality
	Placebo		Mesalamine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/31 (0%)
Serious Adverse Events
	Placebo		Mesalamine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/31 (0%)
Other (Not Including Serious) Adverse Events
	Placebo		Mesalamine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/30 (33.3%)		16/31 (51.6%)
Ear and labyrinth disorders
Motion Sickness	0/30 (0%)	0	1/31 (3.2%)	1
Gastrointestinal disorders
Bloating	1/30 (3.3%)	1	1/31 (3.2%)	1
Diarrhea	1/30 (3.3%)	1	0/31 (0%)	0
Increased bowel movement	0/30 (0%)	0	2/31 (6.5%)	2
Heartburn	1/30 (3.3%)	1	0/31 (0%)	0
Gas	2/30 (6.7%)	2	0/31 (0%)	0
Reflux	1/30 (3.3%)	1	1/31 (3.2%)	1
Hematochezia	0/30 (0%)	0	1/31 (3.2%)	1
General disorders
light headed/dizziness	0/30 (0%)	0	3/31 (9.7%)	3
Swelling	0/30 (0%)	0	1/31 (3.2%)	1
Fatigue	0/30 (0%)	0	1/31 (3.2%)	1
Fever	0/30 (0%)	0	1/31 (3.2%)	1
Sharp pain	0/30 (0%)	0	1/31 (3.2%)	1
Abdominal Pain	1/30 (3.3%)	1	2/31 (6.5%)	2
Nausea	1/30 (3.3%)	1	1/31 (3.2%)	1
Chest Pain	1/30 (3.3%)	1	0/31 (0%)	0
Hepatobiliary disorders
Elevated Liver Function Tests	1/30 (3.3%)	1	0/31 (0%)	0
Metabolism and nutrition disorders
Weight Gain	0/30 (0%)	0	1/31 (3.2%)	1
Respiratory, thoracic and mediastinal disorders
Sinusitis	1/30 (3.3%)	1	2/31 (6.5%)	2
Upper respiratory infection	0/30 (0%)	0	1/31 (3.2%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.