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Fecobionics Device for Chronic Constipation

N/A

Recruiting

Led By Hans Gregersen, MD

Research Sponsored by University of California, San Diego

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Constipation patients: 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.

Normal subjects: Normal defecation pattern, i.e., bowel movement once every day or other day without excessive straining and sense of complete evacuation.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new device that may help to understand and treat chronic constipation. The device, called Fecobionics, is a simulated stool that records pressure, cross-sectional area, orientation, bending, and shape of the rectum and anal canal simultaneously. The goal is to study the defecation dynamics in normal control subjects and compare them to patients with chronic constipation to see if abnormalities of rectal contraction contribute to the condition.

Who is the study for?

This trial is for adults with normal bowel movements or those meeting the Rome IV criteria for chronic constipation, which includes symptoms like infrequent bowel movements and difficulty during defecation. Excluded are pregnant women, individuals unwilling to consent to tests, those with fecal incontinence, significant chronic diseases, medication affecting anorectal function, or a history of relevant surgeries.

What is being tested?

The study is testing how well a new device called Fecobionics can mimic and measure the natural process of defecation by recording various parameters in both healthy subjects and patients with chronic constipation. It aims to improve understanding of normal and abnormal defecatory patterns without using invasive methods or radiation.

What are the potential side effects?

As this trial involves a diagnostic device rather than medication, traditional side effects associated with drugs may not apply. However, participants might experience discomfort or minor pain related to the insertion of the Fecobionics device.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have chronic constipation based on specific symptoms I've had for the last 3 months.

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I have regular bowel movements without difficulty.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Evacuation duration of rectal balloon.

Secondary study objectives

Anorectal angle.

Rectal contraction pressure.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Effect of bisacodyl on the defecationExperimental Treatment1 Intervention

Bisacodyl is a stimulant of rectal contraction and expected to facilitate evacuation of rectal balloon (fecobionics device). Each subject will be studied twice, once with and once without bisacodyl.

Group II: Effect of atropine on the defecationExperimental Treatment1 Intervention

Atropine is an anticholinergic drug and expected to inhibit rectal contractions and inhibit evacuation of the rectal balloon. Each subject will be studied twice once with and once without atropine.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bisacodyl

2008

Completed Phase 4

~3050

0 / 2Eligibility criteria met