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| Name | Class |
|---|---|
| Takeda | INDUSTRY |
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Patients with constipation often have bloating and abdominal distension. It is unclear if this is related to intestinal bacteria. Hypothesis: treatment for constipation may reduce small bowel and colon bacteria colonization, a change in the balance of stool microorganisms, and improve the symptoms of dyspepsia and constipation.
This is an open-label study to collect data on upper and lower GI symptoms, hydrogen breath test, stool PCR, and serum before and after 4 weeks of lubiprostone 24 mcg by mouth twice a day for 4 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment with lubiprostone | Experimental | Subjects receive lubiprostone and bacteria is measured before and after |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lubiprostone | Drug | 24 mcg bid for 28 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Presence of Small Intestinal Bacterial Overgrowth | Percent of patients with bacterial overgrowth before and after treatment. | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Small Bowel and Colon Transit Time by SmartPill® Transit Study | 28 days | |
| Small Intestinal Bacterial Overgrowth (SIBO) | SIBO was measured before and after treatment. | 28 days |
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Inclusion Criteria: Functional constipation by Rome III criteria
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Wo, MD | University of Louisville | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Louisville | Louisville | Kentucky | 40202 | United States |
Study consisted of a 4-week run-in period to wash out prior therapy for constipation. Subjects may withdraw if they can not stay off their medications for constipation.
Subjects recruited from outpatient clinics and advertisement
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| ID | Title | Description |
|---|---|---|
| FG000 | Lubiprostone Open Label |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lubiprostone Open Label |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Presence of Small Intestinal Bacterial Overgrowth | Percent of patients with bacterial overgrowth before and after treatment. | ITT | Posted | Count of Participants | Participants | 28 days |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lubiprostone Open Label | 4-wk treatment period with open label lubiprostone 24 mcg tablet po twice daily |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Transient ischemic attack | Nervous system disorders | Systematic Assessment | One male subject was withdrawn due to developing a transient ischemia attack during the treatment period, and subsequent testing revealed carotid artery atherosclerotic disease. This event was considered unrelated to the study drug. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John M. Wo, MD | University of Louisville | 502-852-6991 | johnwogi@gmail.com |
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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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| ID | Term |
|---|---|
| D000068238 | Lubiprostone |
| ID | Term |
|---|---|
| D000527 | Alprostadil |
| D005229 | Fatty Acids, Monounsaturated |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|
| Participants |
|
|
|
| Secondary | Small Bowel and Colon Transit Time by SmartPill® Transit Study | We were unable to obtain the smart pills for this section of the protocol. | Posted | 28 days |
|
|
| Secondary | Small Intestinal Bacterial Overgrowth (SIBO) | SIBO was measured before and after treatment. | Posted | Number | participants | 28 days |
|
|
|
|
| 1 |
| 25 |
| 0 |
| 25 |
|
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| D008055 |
| Lipids |