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| Name | Class |
|---|---|
| Takeda Pharmaceuticals North America, Inc. | INDUSTRY |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | 20 patients with IBS C |
| |
| D | 20 Subjects without IBS | ||
| B | 20 patients with IBS D |
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| C | 20 patients with IBS M |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| palm pilot recording responses to questionnaires | Other | Short interval assessment (provided by data from palm pilot) may provide a more accurate picture of patient symptom experience. |
| Measure | Description | Time Frame |
|---|---|---|
| To determine relation of pain and bloating relative to average pain and bloating scores | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| determine the association of acute stress with increased pain and bloating scores or with defecation in IBS | 2 weeks |
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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:
In the opinion of the investigator the subject has a concurrent illness or disability (excluding IBS) that may affect the interpretation of clinical efficacy and/or safety data or otherwise contraindicates participation in this clinical study (e.g., an unstable cardiovascular, renal, hepatic, pulmonary, endocrine, metabolic, GI, hematological, or neurological condition).
The subject has been diagnosed with a major psychiatric disorder within the past 2 years that required hospitalization and/or involved an attempted suicide (e.g., major depression or psychoses). Subjects diagnosed with a major psychiatric disorder that did not require hospitalization or involve an attempted suicide must have remained on a stable dose of medication for at least 6 months prior to the screening visit.
The subject has a history of alcohol or substance abuse within the past 2 years.
The subject has any evidence or treatment of malignancy (other than localized basal cell, squamous cell skin cancer or cancer in situ that has been resected) within the previous 5 years.
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Douglas Drossman, MD | UNC-Chapel Hill | Principal Investigator |
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| ID | Term |
|---|---|
| D053560 | Ichthyosis Bullosa of Siemens |
| ID | Term |
|---|---|
| D007057 | Ichthyosis |
| D012868 | Skin Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D007232 | Infant, Newborn, Diseases |
| D007642 | Keratosis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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