Overview

Intestinal Microecology in Chronic Constipation

Status:
Completed

Trial end date:
2012-02-01

Target enrollment:
0

Participant gender:
All

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 Administration (FDA) - approved drug, lubiprostone, has on these bacteria.

Phase:

Phase 1

Accepts Healthy Volunteers?

Accepts Healthy Volunteers

Details

Lead Sponsor:

Mayo Clinic

Collaborators:

Arizona State University
Takeda Pharmaceuticals North America, Inc.

Treatments:

Lubiprostone

Criteria

Inclusion Criteria for Healthy Subjects:

1. 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

2. Absence of current or chronic gastrointestinal symptoms

Inclusion Criteria for Chronic Constipation Subjects:

1. Meet Rome III criteria for chronic functional constipation

2. Colonoscopy within the previous 10 years for subjects ≥ 50 years of age

Inclusion Criteria for Constipation-Predominant IBS Patients:

1. Meet Rome III criteria for C-IBS

2. Colonoscopy within the previous 10 years for subjects ≥ 50 years of age

Exclusion Criteria:

1. Prior gastrointestinal surgery that altered the anatomy of the esophagus, stomach, or
small/large intestine (exceptions include appendectomy and cholecystectomy)

2. Gastrointestinal, cardiovascular, endocrine, renal, or other chronic disease likely to
affect gastrointestinal motility (e.g., uncontrolled diabetes mellitus)

3. 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)

4. Significant untreated psychiatric disease

5. History of hypersensitivity reaction or intolerance to lubiprostone

6. Inability to stop antibiotics, probiotics, and fiber supplements 1 month prior to
stool sample collection

7. 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