Defecation Patterns in Constipated Patients

NCT04903470 | Recruiting

• 1 other identifier: CALM-CLIN-2025-edited
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Constipation by Outlet Obstruction

Keywords

Obstructed defecation; Pelvic floor dysynergia; Paradoxical contraction of the anal sphincter; Anorectal motility; Impedance planimetry of anal sphincter

Outcome Measures

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.

  3 years

Secondary Outcomes (2)

• Rectal contraction pressure.

  3 years

• Anorectal angle.

  4 years

Study Arms (2)

Effect of atropine on the defecation

EXPERIMENTAL

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.

Drug: Atropin

Effect of bisacodyl on the defecation

EXPERIMENTAL

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.

Drug: Bisacodyl

Interventions

Bisacodyl DRUG

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

Also known as: Effect of bisacodyl on the expulsion of rectal balloon (fecobionics device)

Effect of bisacodyl on the defecation

Atropin DRUG

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

Effect of atropine on the defecation

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Normal subjects:

You may not qualify if:

• 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:
• 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.
• 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.

Sponsors & Collaborators

• The California Medical Innovations Institute, Inc.: lead
• Augusta University: collaborator

Study Sites (2)

California Medical Innovations Institute

San Diego, California, 92121, United States

ACTIVE NOT RECRUITING

Augusta University Medical Center

Augusta, Georgia, 30912, United States

RECRUITING

MeSH Terms

Interventions

Bisacodyl; Atropine

Intervention Hierarchy (Ancestors)

Cresols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Officials

• Hans Gregersen, MD, PhD

  California Medical Innovations Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hans Gregersen,, PhD

CONTACT

858-249-7400; hag@giome.org

Satish Rao, MD, PhD

CONTACT

7067212238; srao@augusta.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participant will not know the intended effect of the drug or the drug name.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Model Details: In this crossover study, the subjects receive from one drug up to a sequence of drugs such as atropine and edrophonium to study the effect on defecatory mechanisms.

Study Record Dates

• First Submitted: May 6, 2021
• First Posted: May 26, 2021
• Study Start: December 19, 2022
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: October 21, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)