Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2025-12-24 @ 2:28 PM
NCT ID:
NCT04623359
Eligibility Criteria:
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04623359
Study Brief:
Protocol Section:
NCT04623359