Status:
RECRUITING
Defecation Patterns in Constipated Patients
Lead Sponsor:
The California Medical Innovations Institute, Inc.
Collaborating Sponsors:
Augusta University
Conditions:
Constipation by Outlet Obstruction
Eligibility:
All Genders
21-75 years
Phase:
NA
Brief Summary
Chronic constipation (CC) is a common condition that affects up to 25% of the population in North America. It poses a major burden on the healthcare cost. The pathophysiology of this condition is poor...
Detailed Description
For aim 1 study, the hypothesis is that a correctly performed Valsalva maneuver in the presence of an inflated bag (stool) in the rectum initiates the rectal peristaltic reflex that results in contrac...
Eligibility Criteria
Inclusion
- Two groups of subjects will be studied - normal healthy subjects and patients with chronic constipation.
- Normal subjects:
- Inclusion criteria \*Normal defecation pattern, i.e., bowel movement once every day or other day without excessive straining and sense of complete evacuation.
Exclusion
- Subjects not willing to consent and undergo the specified tests in this study
- Pregnant women
- Subjects with concurrent fecal incontinence and constipation symptoms
- Chronic diseases
- Taking medications that affect anorectal function
- History of anorectal surgery or bowel resection.
- Constipation patients:
- Inclusion Criteria:
- Rome IV diagnostic criteria will be used to diagnose chronic constipation. Patients must have experienced at least two of the following symptoms over the preceding 3 months:
- Fewer than three spontaneous bowel movements per week,
- Straining for more than 25% of defecation attempts,
- Lumpy or hard stools for at least 25% of defecation attempts, and
- sensation of anorectal obstruction or blockage.
- \-
Key Trial Info
Start Date :
December 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2026
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT04903470
Start Date
December 19 2022
End Date
December 30 2026
Last Update
October 21 2025
Active Locations (2)
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1
California Medical Innovations Institute
San Diego, California, United States, 92121
2
Augusta University Medical Center
Augusta, Georgia, United States, 30912