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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK078924 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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Researchers are trying to better understand why constipation occurs and improve the tests for diagnosing these conditions.
Study includes a screening visit and a study day. During the initial screening visit for this study, subjects will complete three (3) questionnaires about their bowel symptoms, overall health, and anxiety and depression. A blood sample (about 4 tablespoons) will be drawn to study the relationship between genes and certain bowel habits. Subjects will be asked to provide a single stool sample to look at the bacteria in the stool.
Before the study, subjects will receive 1 to 2 Fleet's enemas to clean the rectum. After receiving the Fleet's enema (administered through a small plastic tube in the rectum), a swab attached to a small rectal catheter will be used to brush the lining of the rectum and obtain a stool specimen. Then, rectal and anal pressures will be measured by placing a small catheter (plastic tube) in the rectum, and withdrawing it slowly. Rectal sensation will be measured by inflating a small balloon in the rectum.
There are 2 procedures (rectal barostat study and fecomanoflowmetry), each of which lasts approximately 90 minutes. During the rectal barostat study, contractions will be recorded with a balloon inserted into the rectum and inflated. After the barostat study is completed, your rectum will be filled with a small amount of paste. Two thin catheters will be inserted into the anus to measure pressures and electrical activity (electromyography or EMG). Then, you will be asked to sit on a commode, contract (squeeze) your anal muscles, blow into a balloon, and expel the paste into the commode.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Individuals | Active Comparator | Sixty healthy individuals (20 men and 40 women) will undergo an anorectal study which comprises of a rectal barostat study followed by fecoflowmetry |
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| Constipated Individuals | Active Comparator | 60 constipated individuals (20 men and 40 women) will undergo an anorectal study which comprises of a rectal barostat study followed by fecoflowmetry |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rectal Barostat Study | Diagnostic Test | Contractions will be recorded with a balloon inserted into the rectum and inflated |
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| Measure | Description | Time Frame |
|---|---|---|
| Rectal emptying | Measured by fecomanoflowmetry calculating the mean and maximum flow rate in various conditions (mg/sec), defecated volume (mg), flow time (sec) and time to maximum flow (sec). The amount of artificial stool evacuated is expressed in milligrams. The duration is in seconds. These 2 metrics are integrated to measure mg evacuated/second. | Baseline |
| Rectoanal pressures | Measured by anorectal manometry in mmHg | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Anal sphincter electromyography (EMG) | Units - mV | Baseline |
| Rectal compliance measured with a barostat | Pressure (mmHg) corresponding to half-maximum rectal volume during rectal distention |
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Inclusion Criteria
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kelly J Feuerhak | Contact | 507-255-6802 | Feuerhak.Kelly@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Adil E Bharucha, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Recruiting | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
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| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D003248 | Constipation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Fecoflowmetry | Diagnostic Test | Rectum will be filled with a small amount of paste.Two thin catheters will be inserted into the anus to measure pressures and electrical activity (electromyography or EMG). Subjects will be asked to sit on a commode, contract (squeeze) your anal muscles, blow into a balloon, and expel the paste into the commode. |
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| Baseline |
| Rectal Capacity measured with a barostat | Rectal volume (ml) at maximum distending pressure during rectal distention | Baseline |
| Rectal contractile response to distention measured with a sinusoidal oscillator | Rectal balloon is inflated to a preload volume of 125ml. The balloon is then oscillated around baseline volume by 25mL for 20 min at a frequency of 5 counts per minute (cpm). The mean rectal pressure (cm H2O) will be calculated over the multiple oscillation cycles within the 20 minute distention segment. | Baseline |
| Rectal sensory threshold for first sensation to defecate using barostat balloon distention | The sensory threshold for first sensation to defecate is measured by stepwise inflation of the balloon (0-44 mm Hg, at 4 mm Hg increments). During this assessment participants are asked to report when they have the first sensation to defecate. | Baseline |
| Rectal sensory threshold for desire to defecate using barostat balloon distention | The sensory threshold for desire to defecate is measured by stepwise inflation of the balloon (0-44 mm Hg, at 4 mm Hg increments). During this assessment participants are asked to report when they have the desire to defecate. | Baseline |
| Rectal sensory threshold for maximum urgency during barostat balloon distention | The sensory threshold for maximum urgency to defecate is measured by stepwise inflation of the balloon (0-44 mm Hg, at 4 mm Hg increments). During this assessment participants are asked to report when they have the maximum urgency to defecate. | Baseline |
| Rectal balloon expulsion time | During this test, the time (seconds) required to expel a water-filled rectal balloon (50 ml) will be compared between healthy people and patients | Baseline |