Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Constipation
Type
Interventional
Phase
Not Applicable
Design
Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Basic Science

Participation Requirements

Age
Between 18 years and 80 years
Gender
Both males and females

Description

Study includes a screening visit and a study day. During the initial screening visit for this study, subjects will complete three (3) questionnaires about their bowel symptoms, overall health, and anxiety and depression. A blood sample (about 4 tablespoons) will be drawn to study the relationship be...

Study includes a screening visit and a study day. During the initial screening visit for this study, subjects will complete three (3) questionnaires about their bowel symptoms, overall health, and anxiety and depression. A blood sample (about 4 tablespoons) will be drawn to study the relationship between genes and certain bowel habits. Subjects will be asked to provide a single stool sample to look at the bacteria in the stool. Before the study, subjects will receive 1 to 2 Fleet's enemas to clean the rectum. After receiving the Fleet's enema (administered through a small plastic tube in the rectum), a swab attached to a small rectal catheter will be used to brush the lining of the rectum and obtain a stool specimen. Then, rectal and anal pressures will be measured by placing a small catheter (plastic tube) in the rectum, and withdrawing it slowly. Rectal sensation will be measured by inflating a small balloon in the rectum. There are 2 procedures (rectal barostat study and fecomanoflowmetry), each of which lasts approximately 90 minutes. During the rectal barostat study, contractions will be recorded with a balloon inserted into the rectum and inflated. After the barostat study is completed, your rectum will be filled with a small amount of paste. Two thin catheters will be inserted into the anus to measure pressures and electrical activity (electromyography or EMG). Then, you will be asked to sit on a commode, contract (squeeze) your anal muscles, blow into a balloon, and expel the paste into the commode.

Tracking Information

NCT #
NCT03842007
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Adil E Bharucha, MD Mayo Clinic