Trial · NCT01327300
Efficacy of Mesalamine in Diarrhea-predominant Irritable Bowel Syndrome (dIBS)
NCT01327300, Phase 2, Completed, University of Florida; results first posted 2014-02-12
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Efficacy of Mesalamine in Diarrhea-predominant Irritable Bowel Syndrome (dIBS). Trials, record NCT01327300. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01327300
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy of Mesalamine in Diarrhea-predominant Irritable Bowel Syndrome (dIBS)
- NCT number
- NCT01327300
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 7 participants, actual
- Lead sponsor
- University of Florida
- Conditions
- Irritable Bowel Syndrome
- Interventions
- Mesalamine, Placebo
- First posted
- 2011-04-01
- Last updated
- 2014-02-12
- Results first posted
- 2014-02-12
- Limitations and caveats
The recruitment for this study ended on 3/2012 when Dr. Moshiree became adjunct faculty only at the University Florida. This study was limited with over 6 months of follow-up and the need for three endoscopies.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Changes in GIS Scores Between Baseline and After a 12 Week Intervention With Mesalamine or Placebo | Baseline and at 12 weeks post-intervention | Patients rated the severity of their GI symptoms. The GIS scale goes from 1 to 7 with 1 being the worse and 7 as the best score showing improvement in symptoms. The GIS was performed at week one and at week 12 during each of the interventions. The comparisons below list the mean difference for each intervention from baseline (BL) with standard deviations then we list the p-value for the differences of baseline to intervention are reported using the Mann-Whitney test with a two-tailed p value provided. |
| Secondary | Number of Participants Who Had Evidence of Increased Levels of Pathologic Indicators of Colonic Mucosal Inflammation at 12 Weeks Compared to Baseline. | For 2 times: First time: at the time of patient recruitment in the study Second time: after the completion of first 12-week treatment period, all of which are during the time period from 02/25/2010 to 02/01/2012 (up to 2 years) | Colonoscopy/flexible sigmoidoscopy will be performed and mucosal biopsies will be obtained. Each biopsy was stained for activated t lymphocytes, mast cells and eosinophils . CD117 staining was done for Mast cells. H and E staining was used to identify lymphocytes and eosinophils. Each path specimen was then noted to have increased versus normal number of these inflammatory cells. |
| Secondary | Functional Bowel Disorder Severity Index (FBDSI) | An FBDSI score is administered at the beginning of each 12-week treatment period (baseline) and at the end of each 12-week treatment period. | Subjects rate pain on a standardized scale. This is a standardized test used to evaluate patients with IBS. Baseline values are compared to 12 weeks after mesalamine and 12 weeks after placebo treatments. The FBDSI is score is interpreted as such: Severity of IBS is rated as none (0 points), mild (1-36 points), moderate as 37-110 points and severe as \>110 points. Therefore patients can have a score higher than 110. |
| Secondary | IBS - Quality of Life (IBS-QOL)Score. | at the time of recruitment and after completion of each 12-week treatment period, all of which are during the time period from 03/25/2010 to 02/01/2012 (up to 2 years) | A questionnaire is given to each patient and was completed at baseline then after 12 weeks of intervention with mesalamine and then placebo in the cross-over study. The IBS-QOL comprises 34 items with 5-point response scales (0 to 4) that cover eight dimensions of HRQL: dysphoria (8 items), interference with activity (7 items), body image (4 items), health worry (3 items),food avoidance (3 items), social reaction (4 items), sexual concerns (2 items) and relationships (3 items). Higher values indicate better HRQL after converting the raw score on the IBS-QOL into 0 to 100 points. |
| Secondary | Hospital Anxiety and Depression Scale (HADS) | at the time of recruitment and after completion of each 12-week treatment period, all of which are during the time period from 03/25/2010 to 02/01/2012 (up to 2 years) | A questionnaire is given to each patient with scoring done on a Likert scale ranking from 0-42 which combines anxiety and depression scales. Each of these are scored from 0-21 depending on anxiety versus the depression parameters. Comparison of change in HADs after 12 weeks of intervention with either mesalamine or placebo is provided here with only the total value provided-range is from 0-42. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 3 with zero being none at all or occasional and 3 as most of the time. The scale used is a Likert scale and therefore the data returned from the HADS is ordinal. The best score for the HADS therefore is a 0 with the worst score a 42 for combined anxiety and depression scores. For the subscales of depression and anxiety, the best score is a 0 and the worst is a 21. This data is not provided here. Data below includes the change from baseline in the HADS scores. |
| Secondary | Intestinal Permeability Testing | At the completion of each 12-week treatment period, all of which are during the time period from 03/25/2010 to 02/01/2012 (up to 2 years) | Ability of test substances to permeate the intestinal mucosa. The Lactulose/Mannitol test (Genova Diagnostics®, Ashville, NC) directly measures the ability of mannitol and lactulose to permeate the intestinal mucosa. Patient ingests 5 grams of lactulose and 2 grams of mannitol dissolved in a 100 ml of water. Urine is then collected for 24 hours and the ratio of the urinary excretion of lactulose to mannitol is measured. This testing is performed only after completion of each treatment period , after 12 weeks of mesalamine and after 12 weeks of placebo. Normal ratio of lactulose/mannitol is any value \<0.7. An abnormal ratio is defined as \>0.7 ratio. The lactulose is measured in the urine as g/kg and the urinary excretion of mannitol is also measures as g/kg. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Changes in GIS Scores Between Baseline and After a 12 Week Intervention With Mesalamine or Placebo | Baseline and at 12 weeks post-intervention | The first part of the analysis compares the differences between baseline and mesalamine to baseline and placebo. The P value provided below list the comparison of baseline-placebo to baseline-mesalamine using the Mann-Whitney statistical analysis. | units on a scale | MEAN |
| SECONDARY | Number of Participants Who Had Evidence of Increased Levels of Pathologic Indicators of Colonic Mucosal Inflammation at 12 Weeks Compared to Baseline. | For 2 times: First time: at the time of patient recruitment in the study Second time: after the completion of first 12-week treatment period, all of which are during the time period from 02/25/2010 to 02/01/2012 (up to 2 years) | participants | NUMBER | |
| SECONDARY | Functional Bowel Disorder Severity Index (FBDSI) | An FBDSI score is administered at the beginning of each 12-week treatment period (baseline) and at the end of each 12-week treatment period. | Change in Functional Bowel Disorder Severity Index (FBDSI)after 12 weeks of intervention. | units on a scale | MEAN |
| SECONDARY | IBS - Quality of Life (IBS-QOL)Score. | at the time of recruitment and after completion of each 12-week treatment period, all of which are during the time period from 03/25/2010 to 02/01/2012 (up to 2 years) | Data are the mean change in IBS-QOL between baseline and intervention | units on a scale | MEAN |
| SECONDARY | Hospital Anxiety and Depression Scale (HADS) | at the time of recruitment and after completion of each 12-week treatment period, all of which are during the time period from 03/25/2010 to 02/01/2012 (up to 2 years) | units on a scale | MEAN | |
| SECONDARY | Intestinal Permeability Testing | At the completion of each 12-week treatment period, all of which are during the time period from 03/25/2010 to 02/01/2012 (up to 2 years) | ratio | MEAN |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Changes in GIS Scores Between Baseline and After a 12 Week Intervention With Mesalamine or Placebo | Mesalamine | 2.72 | Standard Deviation 1.82 | units on a scale | |
| Changes in GIS Scores Between Baseline and After a 12 Week Intervention With Mesalamine or Placebo | Placebo | 2.22 | Standard Deviation 1.49 | units on a scale | |
| Number of Participants Who Had Evidence of Increased Levels of Pathologic Indicators of Colonic Mucosal Inflammation at 12 Weeks Compared to Baseline. | Mesalamine | Increased Mast cells-CD 117 Positive staining | 2 | participants | |
| Number of Participants Who Had Evidence of Increased Levels of Pathologic Indicators of Colonic Mucosal Inflammation at 12 Weeks Compared to Baseline. | Placebo | Increased Mast cells-CD 117 Positive staining | 2 | participants | |
| Number of Participants Who Had Evidence of Increased Levels of Pathologic Indicators of Colonic Mucosal Inflammation at 12 Weeks Compared to Baseline. | Mesalamine | Increased eosinophil counts | 3 | participants | |
| Number of Participants Who Had Evidence of Increased Levels of Pathologic Indicators of Colonic Mucosal Inflammation at 12 Weeks Compared to Baseline. | Placebo | Increased eosinophil counts | 3 | participants | |
| Number of Participants Who Had Evidence of Increased Levels of Pathologic Indicators of Colonic Mucosal Inflammation at 12 Weeks Compared to Baseline. | Mesalamine | Increased Activated T lymphocytes-CD3 | 2 | participants | |
| Number of Participants Who Had Evidence of Increased Levels of Pathologic Indicators of Colonic Mucosal Inflammation at 12 Weeks Compared to Baseline. | Placebo | Increased Activated T lymphocytes-CD3 | 3 | participants | |
| Functional Bowel Disorder Severity Index (FBDSI) | Mesalamine | -14.5 | Standard Deviation 61.5 | units on a scale | |
| Functional Bowel Disorder Severity Index (FBDSI) | Placebo | 17 | Standard Deviation 71 | units on a scale |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First Intervention (12 Weeks) | STARTED | Mesalamine Then Placebo | 5 | |
| First Intervention (12 Weeks) | STARTED | Placebo Then Mesalamine | 2 | |
| First Intervention (12 Weeks) | COMPLETED | Mesalamine Then Placebo | 5 | |
| First Intervention (12 Weeks) | COMPLETED | Placebo Then Mesalamine | 2 | |
| First Intervention (12 Weeks) | NOT COMPLETED | Mesalamine Then Placebo | 0 | |
| First Intervention (12 Weeks) | NOT COMPLETED | Placebo Then Mesalamine | 0 | |
| Washout (3 Weeks) | STARTED | Mesalamine Then Placebo | 5 | |
| Washout (3 Weeks) | STARTED | Placebo Then Mesalamine | 2 | |
| Washout (3 Weeks) | COMPLETED | Mesalamine Then Placebo | 4 | |
| Washout (3 Weeks) | COMPLETED | Placebo Then Mesalamine | 2 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Mesalamine Then Placebo | ||
| Total, all-cause mortality | Placebo Then Mesalamine | ||
| Total, other adverse events | Mesalamine Then Placebo | 0 | 5 |
| Total, other adverse events | Placebo Then Mesalamine | 0 | 2 |
| Total, serious adverse events | Mesalamine Then Placebo | 0 | 5 |
| Total, serious adverse events | Placebo Then Mesalamine | 0 | 2 |
Source ClinicalTrials.gov
Papers8
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Mesalamine Then Placebo vs Placebo Then Mesalamine: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01327300
GET https://conductscience.org/api/trials/v1/NCT01327300/registered