Actively Recruiting
Understanding Defecation Patterns Using a Novel Device (Fecobionics) to Improve Treatment of Constipation
Led by The California Medical Innovations Institute, Inc. · Updated on 2025-10-21
130
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
T
The California Medical Innovations Institute, Inc.
Lead Sponsor
A
Augusta University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Chronic constipation (CC) affects up to 25% of people in North America and presents challenges due to unclear causes and limited treatment options. This trial studies defecation in normal individuals and patients with CC using a novel device called Fecobionics, which mimics natural stool and records various physiological signals during defecation. The study aims to better understand rectal peristalsis and anorectal function to improve diagnosis and future treatments for CC. Participants will undergo tests using the wireless Fecobionics device that measures pressure, shape, and muscle activity during defecation. Normal volunteers will have muscle activity and ultrasound imaging recorded, and effects of drugs like atropine (which inhibits rectal contractions) and bisacodyl (which stimulates rectal contractions) will be studied in some participants. Patients with CC diagnosed by Rome IV criteria will have similar assessments, with additional tests involving medications to evaluate rectal peristalsis and evacuation. During the study, participants will perform defecation maneuvers while researchers record data from the Fecobionics device, electromyography (EMG), and ultrasound. The primary outcome is the time taken to expel the rectal balloon over three years. Secondary outcomes include measuring rectal contraction pressure and anorectal angle. The research team will use this information to develop mathematical models predicting defecation success. Participation may last up to four years, including follow-up evaluations.
CONDITIONS
Brief Title
Defecation Patterns in Constipated Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Normal healthy subjects must have a normal defecation pattern, with bowel movements once every day or every other day without excessive straining or incomplete evacuation.
- Patients must meet Rome IV criteria for chronic constipation, including at least two symptoms such as fewer than three spontaneous bowel movements per week, straining in more than 25% of attempts, lumpy or hard stools in at least 25% of attempts, or sensation of anorectal blockage.
- Participants must be between 21 and 75 years old.
- Both normal subjects and patients must be willing to consent and undergo the specified tests in the study.
You will not qualify if you...
- Individuals unwilling to consent or undergo the specified study tests.
- Pregnant women.
- Subjects with both fecal incontinence and constipation symptoms simultaneously.
- People with chronic diseases affecting anorectal function.
- Those taking medications that affect anorectal function.
- History of anorectal surgery or bowel resection.
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo baseline tests including Fecobionics expulsion tests, rectal wall ultrasound imaging, and EMG recordings of abdominal wall and external anal sphincter to assess defecation patterns.
1 visit (in-person)
Duration - Multiple sessions over several days
Participants receive interventions with atropine and bisacodyl in a randomized crossover design to study their effects on rectal contractions and defecation using the Fecobionics device and associated measurements.
2 to 4 visits depending on intervention sequence
Duration - Up to several weeks
Participants undergo repeated Fecobionics expulsion tests and imaging after administration of drugs during the intervention period to evaluate changes in defecation patterns and rectal muscle activity.
2 or more follow-up visits
Trial Site Locations
Total: 2 locations
1
California Medical Innovations Institute
San Diego, California, United States, 92121
Active, Not Recruiting
2
Augusta University Medical Center
Augusta, Georgia, United States, 30912
Actively Recruiting
Research Team
H
Hans Gregersen,, PhD
S
Satish Rao, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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