# Defecation mechanisms and subtyping of constipation patients with Fecobionics

> **NIH NIH R01** · CALIFORNIA MEDICAL INNOVATIONS INSTITUTE · 2023 · $559,894

## Abstract

ABSTRACT
Chronic constipation (CC) is a common condition that affects up to 25% of the population in North America with
rising incidence that poses a major burden on the healthcare cost. The pathophysiology of this condition is
poorly understood and consequently there are inadequate treatments. The significant problems are, 1)
incomplete understanding of the defecation reflex and 2) lack of physiologically relevant and practical
diagnostic test for identifying the underlying mechanism(s). Current diagnostic tests provide incomplete and
often conflicting information. Not surprisingly, results of these tests correlate poorly with symptoms and
treatment outcomes. Our objective is to provide an improved understanding of the continence mechanisms
and defecation patterns in healthy subjects and patients with CC using a novel Fecobionics device for mapping
the geometric and manometric profiles during evacuation. Fecobionics is an electronic simulated stool that has
the consistency and shape of normal stool. The device records pressures, cross-sectional area, orientation,
bending, shape, and viscoelastic properties of the rectum and anal canal simultaneously. Our 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. Fecobionics can provide complete picture of the normal defecation
pattern (“signatures”) that includes rectal peristaltic reflex, deformability of the device and distensibility of the
anal sphincters in healthy subjects and patients with various subtypes of CC. The Specific Aims are as
follows: 1) Study the defecation dynamics in normal control subjects using Fecobionics. We 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. We 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. Our 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-fr...

## Key facts

- **NIH application ID:** 10686246
- **Project number:** 5R01DK125657-03
- **Recipient organization:** CALIFORNIA MEDICAL INNOVATIONS INSTITUTE
- **Principal Investigator:** Hans Gregersen
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2023
- **Award amount:** $559,894
- **Award type:** 5
- **Project period:** 2021-06-15 → 2026-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10686246

## Citation

> US National Institutes of Health, RePORTER application 10686246, Defecation mechanisms and subtyping of constipation patients with Fecobionics (5R01DK125657-03). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10686246. Licensed CC0.

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