Defecation Patterns in Constipated Patients

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-75
SponsorThe California Medical Innovations Institute, Inc.

About this trial

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 poorly understood and consequently there are inadequate treatments. Current diagnostic tests provide incomplete and often conflicting information. Fecobionics is an electronic simulated stool that has the consistency and shape of normal stool. The device records pressures, cross-sectional area, orientation, bending, and shape of the rectum and anal canal simultaneously. The central hypothesis is that rectal peristalsis is a key component of the defecatory reflex which is not assessed in the current paradigm of diagnostic testing. The novel Fecobionics device will mimic the natural defecation and provide new mechanistic insights into the anorectal physiology and pathophysiology to facilitate the development of new treatments for CC. The Specific Aims are as follows: 1) Study the defecation dynamics in normal control subjects using Fecobionics. The investigators will establish the role of rectal contraction/peristalsis in the normal evacuation process. 2) Define the defecatory patterns in patients with CC associated with defecatory disorders. The investigators will determine if abnormalities of rectal contraction contribute to the CC. 3) Use a mathematical model of anorectal passage of Fecobionics for enhanced understanding of the normal and abnormal defecatory patterns, including the length-tension properties of the rectum and anal sphincter muscles. The proposal seeks to shift current CC research by providing a stool surrogate for examining the physiologic parameters of defecation reflex using a novel device that will record, pressure, deformability, biomechanics, vectoral and topographic changes in the rectum and anal canal. The noted parameters will be recorded using a wireless Fecobionics device that can examine in detail the mechanistic underpinnings (stress and deformation) of defecation reflex/process in health and disease. The impact of this project is that it assesses a novel, safe, low cost, less invasive, low-risk, radiation-free device in its ability to provide better understanding of evacuation and continence mechanisms and thereby facilitate future development of innovative therapies. The improvement can lead to improvement in diagnostic and therapeutic modalities and reduce healthcare costs associated with anorectal disorders.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • Bisacodyl

    Drug

    Biscodyl a stimulant laxative is expected to stimulate rectal contraction and enhance expulsion of Fecobionics

  • Atropin

    Drug

    Atropin is an anticholinergic drug that is expected to inhibit rectal contractions and make defecation more difficult.

Treatment groups

130 Participants
are divided into 2 treatment groups
Group A: Effect of atropine on the defecationExperimental treatment 1 intervention
Group B: Effect of bisacodyl on the defecationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Evacuation duration of rectal balloon.

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.

Time frame
3 years

Secondary outcomes

1

Rectal contraction pressure.

Rectal contractions, i.e. increase in pressure, will be induced by balloon distension. Change in the rectal pressure baseline induced by Atropine and bisacodyl.

Time frame
3 years
2

Anorectal angle.

The anorectal angle is the angle between the direction of the anal canal and rectum. Change in baseline anorectal angle induced by atropine and bisacodyl.

Time frame
4 years

Other outcomes

Sponsors and contacts

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