Status:
COMPLETED
Intestinal Microecology in Chronic Constipation
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
Arizona State University
Takeda Pharmaceuticals North America, Inc.
Conditions:
Other Constipation
Irritable Bowel Syndrome
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
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 Admi...
Detailed Description
Chronic constipation is a common condition with a heterogeneous pathophysiology and resulting clinical manifestations. Recent evidence in the literature and collected in our laboratory confirm that th...
Eligibility Criteria
Inclusion
- Inclusion Criteria for Healthy Subjects:
- Fewer than 3 bowel movements/day and more than 3 bowel movements/week without the need for significant straining with defecation or frequent sensation of incomplete evacuation after defecation
- Absence of current or chronic gastrointestinal symptoms
- Inclusion Criteria for Chronic Constipation Subjects:
- Meet Rome III criteria for chronic functional constipation
- Colonoscopy within the previous 10 years for subjects ≥ 50 years of age
- Inclusion Criteria for Constipation-Predominant IBS Patients:
- Meet Rome III criteria for C-IBS
- Colonoscopy within the previous 10 years for subjects ≥ 50 years of age
- Exclusion Criteria:
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00934479
Start Date
April 1 2010
End Date
February 1 2012
Last Update
July 17 2013
Active Locations (1)
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1
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85259