NCT00844831

Effects of Lubiprostone on Small Bowel and Colonic Bacteria: A Correlation Study With Segmental and Whole Gut Transit

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: University of Louisville · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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 colon bacteria colonization, a change in the balance of stool microorganisms, and improve the symptoms of dyspepsia and constipation.

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.

Conditions

• Constipation

Interventions

Type	Name	Description
DRUG	Lubiprostone	24 mcg bid for 28 days

Timeline

• Start date: 2009-05-01
• Primary completion: 2011-05-01
• Completion: 2011-05-01
• First posted: 2009-02-16
• Last updated: 2017-07-27
• Results posted: 2017-07-27

Locations

1 site across 1 country: United States