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Sponsors and Collaborators: |
The University of North Carolina, Chapel Hill Takeda Pharmaceuticals North America, Inc. |
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Information provided by: | The University of North Carolina, Chapel Hill |
ClinicalTrials.gov Identifier: | NCT00619125 |
Purpose: The associations between pain, stress, bloating, and their short interval temporal relationships to defecation in IBS D, C & M are of great interest to the field of functional GI disorders, but have not been adequately studied. Broad recall based assessments (i.e.,over past week or month) of pain and bloating have been key features of the diagnosis of IBS, however such long term retrospective recall of symptom experience has been shown to be unreliable and influenced by outside factors (heuristics, recall bias, etc.). Short interval assessment may provide a more accurate picture of patient symptom experience Participants: Patients with IBS in general and IBS subtypes (IBS-C, D, M) Procedures (methods): Study participants could be asked to record data at randomly assigned points throughout the day, as well as during the course of a diarrheal or constipated stool (i.e., prior to and right after a bowel movement).
Condition | Intervention |
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IBS, Diarrhea Predominant IBS, Constipation Predominant IBS, Mixed Symptoms |
Other: palm pilot recording responses to questionnaires |
Study Type: | Observational |
Study Design: | Cohort, Retrospective |
Official Title: | A Proposal to Evaluate Time-Specific Relationships Between Variables of Pain, Stress, and Bloating in the Onset of IBS Diarrhea and Constipation Symptoms Using Ecological Momentary Assessment (EMA) |
Estimated Enrollment: | 80 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | January 2010 |
Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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A
20 patients with IBS C
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Other: palm pilot recording responses to questionnaires
Short interval assessment (provided by data from palm pilot) may provide a more accurate picture of patient symptom experience.
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D
20 Subjects without IBS
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B
20 patients with IBS D
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Other: palm pilot recording responses to questionnaires
Short interval assessment (provided by data from palm pilot) may provide a more accurate picture of patient symptom experience.
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C
20 patients with IBS M
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Other: palm pilot recording responses to questionnaires
Short interval assessment (provided by data from palm pilot) may provide a more accurate picture of patient symptom experience.
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Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Probability Sample |
80 male and female subjects will be recruited: 20 with IBS D; 20 with IBS C; 20 with IBS M; 20 control (no bowel symptoms). We will target patients who have maintained a diagnosis of IBS with Diarrhea (IBS-D), IBS with Constipation (IBS-C, IBS with Mixed Stool pattern (IBS-M), using Rome III Criteria as well as control subjects without bowel symptoms. Subject participation will be limited to patients who maintain mild or moderate symptom severity score on the functional bowel disorders severity index (FBDSI.) providing they have at least 3 symptom episodes of pain or discomfort in a given week, to assure adequate data collection.
Inclusion Criteria:
Exclusion Criteria:
The subject exhibits evidence of a biochemical or structural abnormality of the digestive tract. These conditions include (but are not limited to) the following:
Responsible Party: | UNC-Chapel Hill ( Douglas Drossman, MD ) |
Study ID Numbers: | 07-1782 |
Study First Received: | January 24, 2008 |
Last Updated: | June 24, 2009 |
ClinicalTrials.gov Identifier: | NCT00619125 History of Changes |
Health Authority: | United States: Institutional Review Board |
Signs and Symptoms Diarrhea Signs and Symptoms, Digestive |
Constipation Stress Pain |
Signs and Symptoms Diarrhea Signs and Symptoms, Digestive Constipation |