Effects of Lubiprostone on Small Bowel and Colonic Bacteria: A Correlation Study With Segmental and Whole Gut Transit
This trial is active, not recruiting.
|Sponsor||University of Louisville|
|Start date||May 2009|
|End date||September 2010|
|Trial size||20 participants|
|Trial identifier||NCT00844831, 285.09|
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.
|Endpoint classification||efficacy study|
|Intervention model||crossover assignment|
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
Compare before and after treatment with lubiprostone 24 mcg bid: small bowel and colon transit time by SmartPill® transit study
time frame: 28 days
Male or female participants from 18 years up to 65 years old.
Inclusion Criteria: Functional constipation by Rome III criteria Exclusion Criteria: 1. History of esophageal or gastric surgery (including vagotomy, antireflux, and obesity surgery) 2. History of small bowel or colon resection (excluding appendectomy and cholecystectomy) 3. History of gastric outlet, small bowel, or colon obstruction 4. History of surgery for small bowel adhesion lysis 5. History of surgery for gastroparesis 6. Diagnosis of diabetes requiring daily medications 7. Diagnosis of connective tissue d/o (including scleroderma, lupus, mixed connective tissue disorder) 8. Diagnosis of neuromuscular disorder (including multiple sclerosis, Parkinson, muscular dystrophy, dysautonomia, dystonia) 9. Disorders of small bowel pseudo-obstruction or dumping syndrome 10. Untreated or poorly controlled hypothyroidism 11. Taking an opiate medication daily 12. Taking a medication daily that can cause constipation (calcium channel blocker, anticholinergic, iron supplements, etc.) 13. Active cancer being treated 14. History of significant liver, kidney, cardiac disease that may interfere with study compliance 15. Known allergy or side effects to lubiprostone 16. Non-ambulatory patients: bed-ridden, nursing home resident, etc.
|Official title||Effects of Lubiprostone on Small Bowel and Colonic Bacteria: A Correlation Study With Segmental and Whole Gut Transit|
|Principal investigator||John Wo, MD|
|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.|
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