Trial · NCT01190020
Effect of Lubiprostone on Methanogenesis and Bowel Function in Chronic Constipation.
NCT01190020, Phase 1, Completed, Augusta University; results first posted 2019-01-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effect of Lubiprostone on Methanogenesis and Bowel Function in Chronic Constipation. Trials, record NCT01190020. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01190020
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of Lubiprostone on Methanogenesis and Bowel Function in Chronic Constipation.
- NCT number
- NCT01190020
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 41 participants, actual
- Lead sponsor
- Augusta University
- Conditions
- Chronic Constipation, Methanogenesis
- Interventions
- Lubiprostone, Lubiprostone Control
- First posted
- 2010-08-27
- Last updated
- 2019-01-15
- Results first posted
- 2019-01-15
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Methane Production | Baseline and 1 month | 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. |
| Secondary | Stool Frequency (Complete Spontaneous Bowel Movements) | Baseline and 1 month | change in mean stool frequency (delta) between baseline week and final week of study |
| Secondary | Percentage Change in the Colonic Transit Time | Baseline and 1 month | Percentage change of colonic transit time between the baseline colonic transit study and the colonic transit study at the end of study |
| Secondary | Peak Methane Value | Baseline and 1 month | 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 |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Methane Production | Baseline and 1 month | patients who completed the study were analyzed | parts per million*minutes | MEAN |
| SECONDARY | Stool Frequency (Complete Spontaneous Bowel Movements) | Baseline and 1 month | subjects who completed the study | bowel movements per week | MEAN |
| SECONDARY | Percentage Change in the Colonic Transit Time | Baseline and 1 month | subjects who completed the study | percent | MEAN |
| SECONDARY | Peak Methane Value | Baseline and 1 month | parts per million | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Methane Production | Lubiprostone | 10645 | Standard Error 1481 | parts per million*minutes | |
| Change in Methane Production | Placebo | 14635 | Standard Error 2330 | parts per million*minutes | |
| Stool Frequency (Complete Spontaneous Bowel Movements) | Lubiprostone | 3.71 | Standard Error 0.84 | bowel movements per week | |
| Stool Frequency (Complete Spontaneous Bowel Movements) | Placebo | 0.85 | Standard Error 0.54 | bowel movements per week | |
| Percentage Change in the Colonic Transit Time | Lubiprostone | 0.23 | Standard Error 0.06 | percent | |
| Percentage Change in the Colonic Transit Time | Placebo | 0.48 | Standard Error 0.1 | percent | |
| Peak Methane Value | Lubiprostone | 51.3 | Standard Error 7.1 | parts per million | |
| Peak Methane Value | Placebo | 70.5 | Standard Error 11.2 | parts per million |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lubiprostone | 29 | |
| Overall Study | STARTED | Placebo | 12 | |
| Overall Study | COMPLETED | Lubiprostone | 22 | |
| Overall Study | COMPLETED | Placebo | 12 | |
| Overall Study | NOT COMPLETED | Lubiprostone | 7 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Chest Tightness | Respiratory, thoracic and mediastinal disorders | Lubiprostone | 2 | 29 | |
| other | Chest Tightness | Respiratory, thoracic and mediastinal disorders | Placebo | 0 | 12 | |
| other | Shortness of Breath | Respiratory, thoracic and mediastinal disorders | Lubiprostone | 2 | 29 | |
| other | Shortness of Breath | Respiratory, thoracic and mediastinal disorders | Placebo | 0 | 12 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lubiprostone | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Lubiprostone | 4 | 29 |
| Total, other adverse events | Placebo | 0 | 12 |
| Total, serious adverse events | Lubiprostone | 0 | 29 |
| Total, serious adverse events | Placebo | 0 | 12 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Lubiprostone vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01190020
GET https://conductscience.org/api/trials/v1/NCT01190020/registered