New probe aims to unravel mystery of stubborn constipation
NCT ID NCT04623359
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether a new, high-resolution probe can better diagnose severe constipation that doesn't get better with standard laxatives. Researchers will compare results from healthy volunteers and patients with suspected colonic inertia. The goal is to improve diagnosis and help decide who might benefit from surgery.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 76 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2023
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
For patient Inclusion Criteria: * Age between 18 and 65 years * chronic Constipation (\> 6 months) * delayed colonic transit time \> 100 h * normal colonoscopy * constipation refractory to at least 1 osmotic and 1 stimulant laxative according French guidelines on constipation ; * Affiliated to French national healthcare insurance Exclusion Criteria: * Patient with constipation being either: * With colonic transit time \<100h * Distal (with radio-opaque markers stasis in the rectum) * From organic origin * Recent (\<6 mois) * Relieved using osmotic or stimulant laxatives * Contra-indication to the use of high resolution manometry insertion * Intestinal occlusion * Coagulation disorders, including anti-coagulant treatments * General anesthesia contra-indication * colonoscopy contra-indication * failure to perform a colonoscopy in previous attempts * medication intake that may impair colorectal motility, including opioids * Evolutive inflammatory of neoplasia process * History of major digestive surgery (at exclusion of appendicectomy, cholecystectomy) * Presence of condition that may impact digestive motility, including diabetes mellitus and sclerodermia * Cardiologic disease that may represent a contraindication to vagal stimulation For Healthy volunteers Inclusion Criteria: * Age between 18 and 65 years * Affiliated to French national healthcare insurance Exclusion Criteria: * Significant digestive evolutive disease * constipation with Kess score \> 11/39 and colonic transit time ≥ 60 h * Contra-indication to the use of high resolution manometry insertion * Intestinal occlusion * Cardiac disease * Coagulation disorders, including anti-coagulant treatments * General anesthesia contra-indication * colonoscopy contra-indication * History of major digestive surgery (at exclusion of appendicectomy, cholecystectomy) * Presence of condition that may impact digestive motility, including diabetes mellitus and sclerodermia
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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CHU CAEN
RECRUITINGCaen, 14033, France
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Chu Lille
RECRUITINGLille, 59037, France
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Rouen University Hospital
RECRUITINGRouen, France
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