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NCT01190020 · ClinicalTrials.gov registry record · Phase 1
Effect of Lubiprostone on Methanogenesis and Bowel Function in Chronic Constipation.
A Phase 1 study, sponsored by Augusta University.
- Completed
- Registry status
- Phase 1
- Development phase
- 41
- Enrollment target
NCT01190020: Completed Phase 1 study, sponsored by Augusta University.
NCT01190020 is a Phase 1 study that has completed, run by Augusta University. The registered enrollment target is 41 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (32% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01190020, a Phase 1 study, has completed, sponsored by Augusta University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 41 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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.
Interventions
- DRUG Lubiprostone
- DRUG Lubiprostone Control
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2009-02 |
| Est. Completion | 2012-03 |
| Phase | Phase 1 |
What the finished NCT01190020 record still lists
NCT01190020 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (32% lower).
The record links to 0 conditions, and to 2 interventions - of which Lubiprostone is the first listed.
NCT01190020 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01190020 about?
NCT01190020 is a clinical study titled "Effect of Lubiprostone on Methanogenesis and Bowel Function in Chronic Constipation.". 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 Lubiprosto...
What is the current status of trial NCT01190020?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 41 participants. The study started on 2009-02. Estimated completion is 2012-03.
What interventions are being tested in trial NCT01190020?
The interventions under investigation include: Lubiprostone (DRUG), Lubiprostone Control (DRUG).
Who is sponsoring clinical trial NCT01190020?
This trial is sponsored by Augusta University, which has 106 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01190020's enrollment target sits among peer trials
41 1125th of 2000 higher than 871 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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