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

Completed · Phase 4

Conditions studied: Constipation

In brief

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.

Key facts

Study ID

NCT00844831

Run by

University of Louisville

People needed

25

Starts

2009-05-01

Expected to finish

2011-05-01

Last updated by the study team

2017-07-27

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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.

Where it is running

• University of Louisville — Louisville, Kentucky, United States

Full record on ClinicalTrials.gov

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