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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 is a Phase 1 study that has completed, run by Augusta University. The registered enrollment target is 41 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01190020
The ClinicalTrials.gov registry entry for NCT01190020 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 41 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Augusta University, which has 106 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Lubiprostone is the first listed.
NCT01190020 reports 0 study locations.
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.
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