Defecation Patterns in Constipated Patients Study

This study is looking at how people with chronic constipation (difficulty having bowel movements) experience defecation. Researchers want to understand the natural process of bowel movements better, as current tests don't fully explain why some people have constipation. You could be eligible if you are between 21 and 75 years old. The study will involve two groups: healthy individuals with normal bowel movements and patients with chronic constipation due to outlet obstruction (a type of constipation where there's a problem with the muscles or nerves that help stool leave the body). Researchers will use a special device called Fecobionics, which is like a simulated stool, to measure what happens in the rectum during defecation. They will also study the effects of two medications: Bisacodyl, a stimulant laxative expected to help with bowel movements, and Atropine, which is expected to make bowel movements more difficult. The main goal is to measure how long it takes to expel a rectal balloon. The current status of this study is unclear.

Study design
This is an interventional study with a planned enrollment of 130 participants. It will include both healthy individuals and patients with chronic constipation.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, evacuation duration of a rectal balloon, will be measured at 3 years.

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NCT04903470

Defecation Patterns in Constipated Patients

Recruiting
NAAges 21–75InterventionalBasic science
The California Medical Innovations Institute, Inc.
~130 participants
Updated 2025-10-21 on ClinicalTrials.gov
What's tested:BisacodylAtropin

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Evacuation duration of rectal balloon.
Measured over 3 years
Constipation by Outlet Obstruction
2 sites across 2 states
California1
Georgia1
  • Hans Gregersen, MD, PhD · PRINCIPAL_INVESTIGATOR · California Medical Innovations Institute

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Eligibility criteria

Inclusion

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:

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.
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.
  • Evacuation duration of rectal balloon.3 years

    Evacuation duration is the time it takes from evacuation is initiated until the balloon is expelled. Change from the evacuation duration baseline induced by atropine and bisacodyl.