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Effects of Lubiprostone on Small Bowel and Colonic Bacteria: A Correlation Study With Segmental and Whole Gut Transit
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2009 by University of Louisville.
Recruitment status was: Active, not recruiting
Recruitment status was: Active, not recruiting
Sponsor:
University of Louisville
Collaborator:
Takeda
Information provided by:
University of Louisville
ClinicalTrials.gov Identifier:
NCT00844831
First received: February 13, 2009
Last updated: June 21, 2010
Last verified: April 2009
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Purpose
Patients with constipation often have bloating and abdominal distension. It is unclear if this is related to intestinal bacteria. Hypothesis: treatment for constipation may reduce small bowel and colon bacteria colonization, a change in the balance of stool microorganisms, and improve the symptoms of dyspepsia and constipation.
| Condition | Intervention | Phase |
|---|---|---|
| Constipation | Drug: Lubiprostone | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Crossover Assignment Masking: 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Constipation
Drug Information available for:
Lubiprostone
U.S. FDA Resources
Further study details as provided by University of Louisville:
Primary Outcome Measures:
- Compare before and after treatment with lubiprostone 24 mcg bid: presence of small intestinal bacterial overgrowth and quantitative amount and proportion of each bacteria species by stool DNA polymerase chain reaction. [ Time Frame: 28 days ]
Secondary Outcome Measures:
- Compare before and after treatment with lubiprostone 24 mcg bid: small bowel and colon transit time by SmartPill® transit study [ Time Frame: 28 days ]
| Estimated Enrollment: | 20 |
| Study Start Date: | May 2009 |
| Estimated Study Completion Date: | September 2010 |
| Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Drug: Lubiprostone
24 mcg bid for 28 days
Other Name: Amitiza
This is an open-label study to collect data on upper and lower GI symptoms, hydrogen breath test, stool PCR, and serum before and after 4 weeks of lubiprostone 24 mcg by mouth twice a day for 4 weeks.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00844831
Please refer to this study by its ClinicalTrials.gov identifier: NCT00844831
Locations
| United States, Kentucky | |
| University of Louisville | |
| Louisville, Kentucky, United States, 40202 | |
Sponsors and Collaborators
University of Louisville
Takeda
Investigators
| Principal Investigator: | John Wo, MD | University of Louisville |
More Information
| Responsible Party: | John M. Wo, M.D., University of Louisville |
| ClinicalTrials.gov Identifier: | NCT00844831 History of Changes |
| Other Study ID Numbers: |
285.09 |
| Study First Received: | February 13, 2009 |
| Last Updated: | June 21, 2010 |
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 |
ClinicalTrials.gov processed this record on June 28, 2017