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| Name | Class |
|---|---|
| Takeda Pharmaceuticals North America, Inc. | INDUSTRY |
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Lubiprostone, a chloride channel activator, has been shown to improve symptoms of chronic constipation, largely by enhancing chloride-rich intestinal fluid secretion. Whether Lubiprostone has effects on colonic methanogenesis is not known. The investigators hypothesize that the effects of Lubiprostone may in part be due to its effects on altering colonic flora, particularly methanogenic flora.
By altering the colonic stasis of stool and through more efficient clearance of digestive residue, the investigators anticipate that Lubiprostone may either inhibit or promote better excretion of methanogenic flora, and thereby decrease the gut load of methane producing bacteria. In turn, this may lead to enhanced colonic smooth muscle contraction and an increased rate of spontaneous bowel movements and reduction of constipation symptoms.
The aim is to investigate the effects of Lubiprostone on intestinal methane production and bowel symptoms in patients with chronic constipation, by performing a randomized, double blind, placebo controlled study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lubiprostone | Active Comparator | 24mcg BID for 4 weeks, oral medication |
|
| Placebo | Placebo Comparator | 24mcg BID for 4 weeks (placebo), oral medication |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lubiprostone | Drug | Colonic transit study performed and stool/symptom diaries will be reviewed. Eligible subjects will be given a lactulose breath test and randomized to Lubiprostone or placebo. Treatment group receives 24 mcg Lubiprostone twice daily and placebo group receives pills (identical in appearance to the study drug) for one month. Subjects will be asked to maintain a daily stool/symptom diary for duration of the study. In the middle of the study a research coordinator will call the subjects to take questions/concerns and record adverse events. Lactulose breath test will be repeated, constipation questionnaire filled out, colon transit study performed. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Methane Production | Change in the mean area under the curve of the breath hydrogen and methane gas profiles in parts per million, from time 0 to 120 minutes, between baseline versus mean area under the curve at the end of study. | Baseline and 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Stool Frequency (Complete Spontaneous Bowel Movements) | change in mean stool frequency (delta) between baseline week and final week of study | Baseline and 1 month |
| Percentage Change in the Colonic Transit Time |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States | ||
| University of Utah |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lubiprostone | Received 24 mcg of lubiprostone twice a day with meals. |
| FG001 | Placebo | Received placebo twice a day with meals. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Lubiprostone | |
| BG001 | Placebo | |
| BG002 | Total |
| 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 | Change in Methane Production | Change in the mean area under the curve of the breath hydrogen and methane gas profiles in parts per million, from time 0 to 120 minutes, between baseline versus mean area under the curve at the end of study. | patients who completed the study were analyzed | Posted | Mean | Standard Error | parts per million*minutes | Baseline and 1 month |
|
|
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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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest Tightness | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | 2 subjects experience chest tightness and shortness of breath within one hour of taking the pill. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Summers, MD | University of Iowa | 319-356-2130 | robert-summers@uiowa.edu |
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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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|
| Lubiprostone Control | Drug | Colonic transit study performed and stool/symptom diaries will be reviewed. Eligible subjects will be given a lactulose breath test and randomized to Lubiprostone or placebo. Treatment group receives 24 mcg Lubiprostone twice daily and placebo group receives pills (identical in appearance to the study drug) for one month. Subjects will be asked to maintain a daily stool/symptom diary for duration of the study. In the middle of the study a research coordinator will call the subjects to take questions/concerns and record adverse events. Lactulose breath test will be repeated, constipation questionnaire filled out, colon transit study performed. |
|
Percentage change of colonic transit time between the baseline colonic transit study and the colonic transit study at the end of study
| Baseline and 1 month |
| Peak Methane Value | The peak methane value measured during the baseline breath study will be compared with the peak methane obtained at the end of study breath test | Baseline and 1 month |
| Salt Lake City |
| Utah |
| 84112 |
| United States |
| Withdrawal by Subject |
|
Total of all reporting groups
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
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| Secondary | Stool Frequency (Complete Spontaneous Bowel Movements) | change in mean stool frequency (delta) between baseline week and final week of study | subjects who completed the study | Posted | Mean | Standard Error | bowel movements per week | Baseline and 1 month |
|
|
|
| Secondary | Percentage Change in the Colonic Transit Time | Percentage change of colonic transit time between the baseline colonic transit study and the colonic transit study at the end of study | subjects who completed the study | Posted | Mean | Standard Error | percent | Baseline and 1 month |
|
|
|
| Secondary | Peak Methane Value | The peak methane value measured during the baseline breath study will be compared with the peak methane obtained at the end of study breath test | Posted | Mean | Standard Error | parts per million | Baseline and 1 month |
|
|
|
| 0 |
| 29 |
| 4 |
| 29 |
| EG001 | Placebo | 0 | 12 | 0 | 12 |
|
| Shortness of Breath | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | 2 subjects experienced chest tightness and shortness of breath within one hour of taking the pill. |
|
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| D008055 |
| Lipids |