NCT03842007

Understanding Mechanisms of Normal and Disordered Defecation

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

Researchers are trying to better understand why constipation occurs and improve the tests for diagnosing these conditions.

Detailed 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 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.

Conditions

• Constipation

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Rectal Barostat Study	Contractions will be recorded with a balloon inserted into the rectum and inflated
DIAGNOSTIC_TEST	Fecoflowmetry	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). Subjects will be asked to sit on a commode, contract (squeeze) your anal muscles, blow into a balloon, and expel the paste into the commode.

Timeline

• Start date: 2019-01-29
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2019-02-15
• Last updated: 2025-08-05

Locations

1 site across 1 country: United States