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 @ 2:55 PM
Ignite Modification Date:
2025-12-24 @ 2:55 PM
NCT ID:
NCT03806959
Eligibility Criteria:
Inclusion Criteria:
* Male or female: Age ≥ 18 years and ≤ 50 years
* Patients with symptoms compatible with IBS-D or IBS-M according to the treating physician.
* Indication for colonoscopy according to the physician
* Absence of prior colonoscopy
* Patient affiliated to a social security Insurance
* Signature of signed informed consent.
Exclusion Criteria:
* Functional or organic disorders of swallowing.
* Dysphagia or suspicion of digestive stenosis.
* Known Zenker Diverticule.
* Major surgical history of the digestive tract (exclusion of appendectomy, cholecystectomy, surgery of hemorrhoids).
* Known illness that could explain digestive symptoms.
* Symptoms suggestive of occlusion.
* Alteration of the general state and / or dehydration.
* Chronic uncontrolled disease.
* Disorders of consciousness.
* Uncontrolled heart disease: myocardial infarction in the last 6 months, anginal disease status, NYHA grade III and above congestive heart failure, ventricular tachycardia, ventricular fibrillation, severe heart block.
* Patient with a pacemaker or other implantable electronic medical device.
* Polyethylene glycol allergy.
* Oral iron intake in the four days preceding the video capsule.
* Pregnant or lactating woman, woman of childbearing age who has not performed a pregnancy test, women and men of childbearing potential without effective contraception.
* Impossible follow up for psychological or geographical reasons.
* Patient under safeguard of justice.
* Patient under guardianship or curatorship.
* Simultaneous participation in another clinical study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT03806959
Study Brief:
Protocol Section:
NCT03806959