Intestinal Microecology in Chronic Constipation

Completed · Phase 1

Conditions studied: Other Constipation, Irritable Bowel Syndrome

In brief

The purpose of this study is to determine whether the bacteria normally present in the bowels are different in people with constipation and to see what effect the treatment with the Food and Drug Administration (FDA) - approved drug, lubiprostone, has on these bacteria.

Key facts

Study ID

NCT00934479

Run by

Mayo Clinic

People needed

21

Starts

2010-04-01

Expected to finish

2012-02-01

Last updated by the study team

2013-07-17

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• Prior gastrointestinal surgery that altered the anatomy of the esophagus, stomach, or small/large intestine (exceptions include appendectomy and cholecystectomy)
• Gastrointestinal, cardiovascular, endocrine, renal, or other chronic disease likely to affect gastrointestinal motility (e.g., uncontrolled diabetes mellitus)
• Females of childbearing age who are not practicing birth control and/or are pregnant or lactating (a urine pregnancy test will be performed on female subjects prior to lubiprostone use)
• Significant untreated psychiatric disease
• History of hypersensitivity reaction or intolerance to lubiprostone
• Inability to stop antibiotics, probiotics, and fiber supplements 1 month prior to stool sample collection
• Inability to stop proton pump inhibitors, histamine 2 receptor antagonists, prokinetic agents, narcotic analgesic agents, laxatives, and anticholinergic agents 2 weeks prior to stool sample collection

Where it is running

• Mayo Clinic Arizona — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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