Measuring defecation mechanics in people with outlet obstruction constipation
Understanding Defecation Patterns Using a Novel Device (Fecobionics) to Improve Treatment of Constipation
This test uses a stool-like device called Fecobionics to see if it can measure muscle and pressure changes during bowel movements in people with outlet obstruction and in healthy volunteers.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 21 Years to 75 Years |
| Sex | All |
| Sponsor | The California Medical Innovations Institute, Inc. Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (San Diego, California and 1 other locations) |
| Trial ID | NCT04903470 on ClinicalTrials.gov |
What this trial studies
The study uses an electronic simulated stool (Fecobionics) that records pressures, cross-sectional area, orientation, bending, and shape as it is expelled to mimic natural defecation. Investigators will combine Fecobionics with abdominal wall and external anal sphincter EMG and high-frequency rectal ultrasound to separate contributions from abdominal and rectal muscle activity. Separate experiments include pharmacologic manipulation with atropine to block rectal smooth muscle and use of bisacodyl as needed for expulsion challenges, enrolling healthy volunteers and patients meeting Rome IV criteria for obstructed defecation. Data will compare spatiotemporal patterns of pressure and muscle activity between groups to define rectal peristalsis and the defecatory reflex.
Who should consider this trial
Good fit: Adults with chronic constipation due to outlet obstruction by Rome IV criteria, and healthy adults with normal daily or alternate-day bowel movements without excessive straining, who can consent and undergo the tests are ideal candidates.
Not a fit: People with concurrent fecal incontinence, recent anorectal surgery or bowel resection, major chronic diseases, pregnancy, or those taking medications that affect anorectal function are excluded and unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this device could improve diagnosis of defecatory disorders and guide development of more targeted treatments for obstructed defecation.
How similar studies have performed: This Fecobionics approach is relatively novel and comprehensive simultaneous recordings of pressure, shape, and muscle activity during defecation are limited clinically, so the method is largely untested in broad patient populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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 Criteria:
* 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:
1. Fewer than three spontaneous bowel movements per week,
2. Straining for more than 25% of defecation attempts,
3. Lumpy or hard stools for at least 25% of defecation attempts, and
4. sensation of anorectal obstruction or blockage.
\-
Exclusion Criteria:
* Patients not willing to consent and undergo the specified tests in this study
* pregnant women and patients with concurrent fecal incontinence
* History of anorectal surgery or bowel resection.
Where this trial is running
San Diego, California and 1 other locations
- California Medical Innovations Institute — San Diego, California, United States (Active_not_recruiting)
- Augusta University Medical Center — Augusta, Georgia, United States (Recruiting)
Study contacts
- Principal investigator: Hans Gregersen, MD, PhD — California Medical Innovations Institute
- Study coordinator: Hans Gregersen,, PhD
- Email: hag@giome.org
- Phone: 858-249-7400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.