Effects of Lubiprostone on Small Bowel and Colonic Bacteria: A Correlation Study With Segmental and Whole Gut Transit
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ClinicalTrials.gov Identifier: NCT00844831 |
Recruitment Status
:
Completed
First Posted
: February 16, 2009
Results First Posted
: July 27, 2017
Last Update Posted
: July 27, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Constipation | Drug: Lubiprostone | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 25 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Effects of Lubiprostone on Small Bowel and Colonic Bacteria: A Correlation Study With Segmental and Whole Gut Transit |
Study Start Date : | May 2009 |
Actual Primary Completion Date : | May 2011 |
Actual Study Completion Date : | May 2011 |

Arm | Intervention/treatment |
---|---|
Experimental: Treatment with lubiprostone
Subjects receive lubiprostone and bacteria is measured before and after
|
Drug: Lubiprostone
24 mcg bid for 28 days
Other Name: Amitiza
|
- Presence of Small Intestinal Bacterial Overgrowth [ Time Frame: 28 days ]Percent of patients with bacterial overgrowth before and after treatment.
- Small Bowel and Colon Transit Time by SmartPill® Transit Study [ Time Frame: 28 days ]
- Small Intestinal Bacterial Overgrowth (SIBO) [ Time Frame: 28 days ]SIBO was measured before and after treatment.

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria: Functional constipation by Rome III criteria
Exclusion Criteria:
- History of esophageal or gastric surgery (including vagotomy, antireflux, and obesity surgery)
- History of small bowel or colon resection (excluding appendectomy and cholecystectomy)
- History of gastric outlet, small bowel, or colon obstruction
- History of surgery for small bowel adhesion lysis
- History of surgery for gastroparesis
- Diagnosis of diabetes requiring daily medications
- Diagnosis of connective tissue d/o (including scleroderma, lupus, mixed connective tissue disorder)
- Diagnosis of neuromuscular disorder (including multiple sclerosis, Parkinson, muscular dystrophy, dysautonomia, dystonia)
- Disorders of small bowel pseudo-obstruction or dumping syndrome
- Untreated or poorly controlled hypothyroidism
- Taking an opiate medication daily
- Taking a medication daily that can cause constipation (calcium channel blocker, anticholinergic, iron supplements, etc.)
- Active cancer being treated
- History of significant liver, kidney, cardiac disease that may interfere with study compliance
- Known allergy or side effects to lubiprostone
- Non-ambulatory patients: bed-ridden, nursing home resident, etc.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00844831
United States, Kentucky | |
University of Louisville | |
Louisville, Kentucky, United States, 40202 |
Principal Investigator: | John Wo, MD | University of Louisville |
Responsible Party: | University of Louisville |
ClinicalTrials.gov Identifier: | NCT00844831 History of Changes |
Other Study ID Numbers: |
285.09 |
First Posted: | February 16, 2009 Key Record Dates |
Results First Posted: | July 27, 2017 |
Last Update Posted: | July 27, 2017 |
Last Verified: | June 2017 |
Keywords provided by University of Louisville:
Constipation small intestinal bacterial overgrowth stool bacteria |
Additional relevant MeSH terms:
Constipation Signs and Symptoms, Digestive Signs and Symptoms Lubiprostone |
Chloride Channel Agonists Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action |