Status:
COMPLETED
Effects of Lubiprostone on Small Bowel and Colonic Bacteria: A Correlation Study With Segmental and Whole Gut Transit
Lead Sponsor:
University of Louisville
Collaborating Sponsors:
Takeda
Conditions:
Constipation
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
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 colo...
Detailed Description
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 Criteria
Inclusion
- Functional constipation by Rome III criteria
Exclusion
- 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.
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00844831
Start Date
May 1 2009
End Date
May 1 2011
Last Update
July 27 2017
Active Locations (1)
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1
University of Louisville
Louisville, Kentucky, United States, 40202