NCT03317938

Studies in Patients With Defecatory Disorders

Completed NA Last updated 26 December 2025

What this trial tests

NA trial testing Fecobionics in Fecal Incontinence in 236 participants. Completed in 31 December 2024.

Timeline

14 August 2017

Primary endpoint
31 December 2024

31 December 2024

Quick facts

Lead sponsor	Giome
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	236
Start date	14 August 2017
Primary completion	31 December 2024
Estimated completion	31 December 2024
Sites	2 locations across Hong Kong

Drugs / interventions tested

• Fecobionics

Conditions studied

• Fecal Incontinence — all drugs for Fecal Incontinence →
• Constipation — all drugs for Constipation →

Sponsor

Giome

Who can join

18 and older, any sex, with Fecal Incontinence or Constipation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Defecatory disorders like chronic constipation and faecal incontinence affect 25% of the population with rising incidence. Defecatory disorders pose a major health care burden and are poorly recognized and treated. The need for better diagnostics and therapeutics is substantial.

Current assessment of patients with constipation and faecal incontinence include endoscopic assessment to rule out intraluminal organic cause for patients' symptoms, endoanal ultrasound scan / MRI to assess patients' pelvic floor anatomy and anorectal manometry and balloon expulsion test to assess anorectal function. All tests are susceptible to measurement artifacts.

The standard technologies for anorectal assessment are anorectal manometry, balloon expulsion test and defecography. Endoluminal Functional Lumen Imaging Probe (EndoFLIP©) is a novel technology, originally used to measure the dimensions and function of a hollow organ. Anorectal manometry, balloon expulsion test, defecography, and the EndoFLIP probe will be used in the proposed studies. In addition, the proposed study intends to use a simulated feces named Fecobionics which is a device that integrates several technologies into one which will save time and reduce test variability.

In the proposed studies investigators will assess defecatory function in subgroups of Hong Kong patients suffering from chronic constipation and faecal incontinence and determine biomarkers to increase the diagnostic value of anorectal testing. Investigators will study up to 130 patients with anorectal disorders and 101 healthy control subjects. Investigators anticipate to improve diagnostics of anorectal disorders considerably and to learn about physiological mechanisms that affect defecatory efficacy.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Novel Fecobionics Defecatory Function Testing.
   Gregersen H, Chen SC, Leung WW, Wong C, et al · · 2019 · cited 23× · PMID 31800543 · DOI 10.14309/ctg.0000000000000108
2. Characterization of Patients With Obstructed Defecation and Slow Transit Constipation With a Simulated Stool.
   Gregersen H, Chen SC, Leung WW, Wong C, et al · · 2021 · cited 13× · PMID 33949343 · DOI 10.14309/ctg.0000000000000354
3. Mechanophysiological analysis of anorectal function using simulated feces in human subjects.
   Sun D, Liao D, Chen SC, Wong C, et al · · 2021 · cited 13× · PMID 33364060 · DOI 10.1016/j.jare.2020.07.002
4. Fecobionics assessment of the effect of position on defecatory efficacy in normal subjects.
   Chen SC, Futaba K, Leung WW, Wong C, et al · · 2021 · cited 10× · PMID 33779850 · DOI 10.1007/s10151-021-02439-2
5. New developments in defecatory studies based on biomechatronics.
   Gregersen H, Sun D, Chen SC, Leung WW, et al · · 2022 · cited 9× · PMID 35003792 · DOI 10.1016/j.jare.2021.05.005
6. Fecobionics characterization of female patients with fecal incontinence.
   Futaba K, Chen SC, Leung WW, Wong C, et al · · 2022 · cited 6× · PMID 35732729 · DOI 10.1038/s41598-022-14919-y
7. Fecobionics Evaluation of Biofeedback Therapy in Patients With Fecal Incontinence.
   Futaba K, Chen SC, Leung WW, Wong C, et al · · 2022 · cited 6× · PMID 35363631 · DOI 10.14309/ctg.0000000000000491
8. Rectal contractility in patients with fecal incontinence and obstructed defecation compared to normal subjects.
   Gregersen H, Mittal RK. · · 2023 · cited 1× · PMID 37464998 · DOI 10.1016/j.gastha.2023.03.002