Phase 2 N=7 Randomized Double-blind Treatment

Efficacy of Mesalamine in Diarrhea-predominant Irritable Bowel Syndrome (dIBS)

Irritable Bowel Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT01327300 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2014

Primary outcome: Primary: Changes in GIS Scores Between Baseline and After a 12 Week Intervention With Mesalamine or Placebo — 2.72; 2.22 units on a scale — p=.001

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Mesalamine (Drug); Placebo (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Florida
Primary completion: Mar 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Changes in GIS Scores Between Baseline and After a 12 Week Intervention With Mesalamine or Placebo	2.72; 2.22	.001 sig
SECONDARY Number of Participants Who Had Evidence of Increased Levels of Pathologic Indicators of Colonic Mucosal Inflammation at 12 Weeks Compared to Baseline.	2; 2; 3; 3; 2; 3	0.873
SECONDARY Functional Bowel Disorder Severity Index (FBDSI)	-14.5; 17	0.67
SECONDARY IBS - Quality of Life (IBS-QOL)Score.	11; -12.2	0.61
SECONDARY Hospital Anxiety and Depression Scale (HADS)	1.2; -2.4; 14; 13	0.71
SECONDARY Intestinal Permeability Testing	0.07; 0.04	0.55

Summary

The purpose of this study is to find whether treating patients with diarrhea predominant Irritable Bowel Syndrome (IBS) with an anti-inflammatory drug called Mesalamine will help improve their symptoms of diarrhea, bloating and abdominal pain.

Eligibility Criteria

Inclusion Criteria

Male and female aged 18-65 years old
Functional Bowel Disorder Severity Index Score above 37
Normal complete blood count, liver function studies and renal function studies
Serologies done to rule out Celiac Spure or patient has prior negative EGD with small bowel biopsies which have been negative
Infectious diarrhea ruled out by stool studies
Negative colonoscopy

Exclusion Criteria

Any history of chronic liver disease, heart disease, pulmonary or renal disease
Abnormal EKG
Women with positive pregnancy tests
Patient on steroids, antacids, or warfarin or chronic pain conditions other than fibromyalgia
Patients who drink over 2oz alcohol/day on a regular basis Any other causes for diarrhea such as IBD, microscopic colitis, celiac disease, history of abdominal obstruction, pancreatitis, ileus, or any gastrointestinal bleeding.
Patients with active malignancy in the past five years
Patient with any history of hypersensitivity reactions to salicylate containing medications due to cross-sensitivity with mesalamine or allergy to mesalamine medications in the past
Any subjects with fibromyalgia will be excluded from the pain testing portion only
History of Phenylketonuria due to the aspartame contained in Apriso

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01327300). 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.