Fecal IncontinenceNCT03317938
Studies in Patients With Defecatory Disorders
A study testing Fecobionics in people with Fecal Incontinence and Constipation, run by Giome at 2 sites in Hong Kong.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fecal Incontinence, Constipation
- What is being tested?
- Fecobionics
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 2 sitesHong Kong
- Study dates
- 14 Aug 2017to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subjects: Asymptomatic healthy persons aged over 18 years who can give informed consent.
- CC (Chronic Constipation) Patients: Patients over 18 with history of FI for over 3months, who are able to give consent.
- FI (Fecal Incontinence) patients: Patients over 18 with history of FI for over 3months, who are able to give consent.
- Patients with a stoma who are over 18 years and able to give consent.
Who cannot join
- Healthy subjects: Persons with a history of constipation or fecal incontinence, prior abdominal surgery, medication, and diseases, especially chronic diseases that affect bowel function and defecation. Pregnant women will also be excluded.
- CC Patients: Patients, who are not willing to undergo the proposed test program and patients with prior anorectal or intestinal surgery. Pregnant women and patients with chronic dehydration and on medications like opioids will also be excluded.
- FI patients: 1) Patients who are not willing to undergo the specified tests in this study, 2) Pregnant women and 3) Patients who has had anorectal surgery or bowel resection.
- Patients with stoma: Patients, who are not willing to undergo the proposed test program and patients who have inflammation or symptoms related to the stoma.
Trial locations and contacts
2 sites in 1 country.
Hong Kong2 sites
Prince of Wales Hospital
Hong Kong, Hong Kong, 000000
Department of Surgery, Prince of Wales Hospital
Hong Kong, 0000
About this study
Official title: Unraveling Anorectal Function and Biomarker Signatures in Patients Suffering From Subtypes of Defecatory Disorders
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.
Read more
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.
Read the detailed 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. Currently management options for these patients are limited, partly due to the fact that control of defaecation and continence is multifactorial but also due to the fact that it is difficult to identify the exact cause of patients' incontinence. Even in healthy subjects, many aspects of defecatory mechanisms are yet not well understood.
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, with a high inter-individual variation with significant overlap between healthy asymptomatic and symptomatic patients.
The standard technologies for anorectal assessment are anorectal manometry, ballon 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. A major difference from EndoFLIP and other technologies like anorectal manometry is that the device will be defecated rather than providing static data from one location in the anal canal.
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. For example, one substudy investigates the effect of posture on defecation and another substudy focuses on deferred defecation. A third study assessed defecatory parameters as a function of the stiffness of Fecobionics. Pelvic floor function will also be assessed through vaginal measurements as well as Fecobionics may be endoscopically placed in sigmoid colon. Finally, a substudy assessed intestinal parameters after insertion of Fecobionics through a stoma.
- Conditions
- Fecal Incontinence, Constipation
- Being tested
- Fecobionics
- Medical subject headings
- Fecal Incontinence, Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FecobionicsDevice
Fecobionics is a new device for studying defecation
| Study group | Role | What they receive |
|---|---|---|
| Fecobionics studies | Experimental | Not described Receives: Device: Fecobionics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decreased anorectal pressure assessed with the Fecobionics device
The number of participants with low anorectal pressure during defecation
Measured: 1 year
Secondary outcomes (3)
Decreased anorectal mechanical stress assessed with the Fecobionics device
The number of participants with low anorectal mechanical stress during defecation
Measured: 1 year
Decreased anorectal angle assessed with the Fecobionics device
The number of participants with small anorectal angle during defecation
Measured: 1 year
Wave-like decrease in cross-sectional area with the Fecobionics device
The amount of recordings with retrograde intestinal ripples
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2017
- Study start14 Aug 2017
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Fecal IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- Giome
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hans Gregersen, Giome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03317938
- Sponsor's protocol ID
- 2017.122
- Status last verified
- Dec 2025
- First submitted
- 3 Oct 2017
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Futaba K, Chen SC, Leung WW, Wong C, Mak T, Ng S, Gregersen H. Fecobionics Evaluation of Biofeedback Therapy in Patients With Fecal Incontinence. Clin Transl Gastroenterol. 2022 May 1;13(5):e00491. doi: 10.14309/ctg.0000000000000491.
PubMed 35363631Gregersen H, Chen SC, Leung WW, Wong C, Mak T, Ng S, Daming S, Futaba K. Characterization of Patients With Obstructed Defecation and Slow Transit Constipation With a Simulated Stool. Clin Transl Gastroenterol. 2021 May 5;12(5):e00354. doi: 10.14309/ctg.0000000000000354.
PubMed 33949343Chen SC, Futaba K, Leung WW, Wong C, Mak T, Ng S, Gregersen H. Fecobionics assessment of the effect of position on defecatory efficacy in normal subjects. Tech Coloproctol. 2021 May;25(5):559-568. doi: 10.1007/s10151-021-02439-2. Epub 2021 Mar 29.
PubMed 33779850Gregersen H, Chen SC, Leung WW, Wong C, Mak T, Ng S, Futaba K. Novel Fecobionics Defecatory Function Testing. Clin Transl Gastroenterol. 2019 Dec;10(12):e00108. doi: 10.14309/ctg.0000000000000108.
PubMed 31800543
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unraveling Anorectal Function and Biomarker Signatures in Patients Suffering From Subtypes of Defecatory Disorders
- ClinicalTrials.gov ID
- NCT03317938
- Acronym / sponsor ID
- 2017.122
- Conditions
- Fecal Incontinence, Constipation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- GiomeUniversity, hospital or other
- Study start
- 14 Aug 2017 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 23 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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. Currently management options for these patients are limited, partly due to the fact that control of defaecation and continence is multifactorial but also due to the fact that it is difficult to identify the exact cause of patients' incontinence. Even in healthy subjects, many aspects of defecatory mechanisms are yet not well understood.
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, with a high inter-individual variation with significant overlap between healthy asymptomatic and symptomatic patients.
The standard technologies for anorectal assessment are anorectal manometry, ballon 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. A major difference from EndoFLIP and other technologies like anorectal manometry is that the device will be defecated rather than providing static data from one location in the anal canal.
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. For example, one substudy investigates the effect of posture on defecation and another substudy focuses on deferred defecation. A third study assessed defecatory parameters as a function of the stiffness of Fecobionics. Pelvic floor function will also be assessed through vaginal measurements as well as Fecobionics may be endoscopically placed in sigmoid colon. Finally, a substudy assessed intestinal parameters after insertion of Fecobionics through a stoma.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fecobionics studies | Experimental | Device: Fecobionics |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy subjects: Asymptomatic healthy persons aged over 18 years who can give informed consent.
- CC (Chronic Constipation) Patients: Patients over 18 with history of FI for over 3months, who are able to give consent.
- FI (Fecal Incontinence) patients: Patients over 18 with history of FI for over 3months, who are able to give consent.
- Patients with a stoma who are over 18 years and able to give consent.
Key exclusion criteria (4 listed)
- Healthy subjects: Persons with a history of constipation or fecal incontinence, prior abdominal surgery, medication, and diseases, especially chronic diseases that affect bowel function and defecation. Pregnant women will also be excluded.
- CC Patients: Patients, who are not willing to undergo the proposed test program and patients with prior anorectal or intestinal surgery. Pregnant women and patients with chronic dehydration and on medications like opioids will also be excluded.
- FI patients: 1) Patients who are not willing to undergo the specified tests in this study, 2) Pregnant women and 3) Patients who has had anorectal surgery or bowel resection.
- Patients with stoma: Patients, who are not willing to undergo the proposed test program and patients who have inflammation or symptoms related to the stoma.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FecobionicsFecobionics is a new device for studying defecation | Device | Fecobionics studies |
Primary outcome
Decreased anorectal pressure assessed with the Fecobionics device
Time frame: 1 year
The number of participants with low anorectal pressure during defecation
3 secondary outcomes
Decreased anorectal mechanical stress assessed with the Fecobionics device
Time frame: 1 year
Decreased anorectal angle assessed with the Fecobionics device
Time frame: 1 year
Wave-like decrease in cross-sectional area with the Fecobionics device
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- Derived from this study: PubMed 35363631Futaba K, Chen SC, Leung WW, Wong C, Mak T, Ng S, Gregersen H. Fecobionics Evaluation of Biofeedback Therapy in Patients With Fecal Incontinence. Clin Transl Gastroenterol. 2022 May 1;13(5):e00491. doi: 10.14309/ctg.0000000000000491.
- Derived from this study: PubMed 33949343Gregersen H, Chen SC, Leung WW, Wong C, Mak T, Ng S, Daming S, Futaba K. Characterization of Patients With Obstructed Defecation and Slow Transit Constipation With a Simulated Stool. Clin Transl Gastroenterol. 2021 May 5;12(5):e00354. doi: 10.14309/ctg.0000000000000354.
- Derived from this study: PubMed 33779850Chen SC, Futaba K, Leung WW, Wong C, Mak T, Ng S, Gregersen H. Fecobionics assessment of the effect of position on defecatory efficacy in normal subjects. Tech Coloproctol. 2021 May;25(5):559-568. doi: 10.1007/s10151-021-02439-2. Epub 2021 Mar 29.
- Derived from this study: PubMed 31800543Gregersen H, Chen SC, Leung WW, Wong C, Mak T, Ng S, Futaba K. Novel Fecobionics Defecatory Function Testing. Clin Transl Gastroenterol. 2019 Dec;10(12):e00108. doi: 10.14309/ctg.0000000000000108.
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The Safety and Efficacy of 5-HT3 Receptor Antagonist (Ramosetron) for the Treatment of Fecal Incontinence
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Fecal Incontinence (FI) is a Debilitating Physical and Psychological Disorder Characterizedbytheinvoluntary Loss of Flatus or Liquid/Solid Stool.
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Pelvic Health Electrically Evoked Recording (PEER) 2 Study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fecobionics in people with Fecal Incontinence and Constipation, run by Giome at 2 sites in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decreased anorectal pressure assessed with the Fecobionics device (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03317938, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025; AzTrials last refreshed its copy on 30 Oct 2026.