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:
2025-12-25 @ 4:41 AM
Ignite Modification Date:
2025-12-25 @ 4:41 AM
NCT ID:
NCT01347918
Eligibility Criteria:
Inclusion criteria:
* Healthy volunteers and IBS patients must fill out the validated Birmingham IBS Symptom Questionnaire
* Healthy volunteers must be symptom free of any abdominal complaints.
* IBS patients are defined based on clinical symptoms as described in the Rome III criteria for irritable bowel syndrome:
* Symptoms of recurrent abdominal pain or discomfort and a marked change in bowel habit for at least six months, with symptoms experienced on at least three days of at least three months. Two or more of the following must apply:
* Pain is relieved by bowel movement
* Onset of pain is related to a change in frequency of stool
* Onset of pain is related to a change in the appearance of stool
* Written informed consent
Exclusion criteria:
* Age under 18 or above 65
* Pathologic underweight or overweight (BMI \<18 or \>30kg/m2)
* Previous history of gastrointestinal disease or surgery (excludes appendectomy, cholecystectomy, hernia repair and anorectal disorders)
* Previous cardiorespiratory (excludes arterial hypertension), hematologic, renal, atopic, alimentary or psychiatric disease, diabetes, drug or alcohol abuse, psychiatric disease
* Patient unable to stop medication that alters gut function for 72 hours prior to the study, including anticholinergics, prokinetics, proton-pump inhibitors, non-steroidal antiinflammatory drugs
* Presence of metallic implants, devices or metallic foreign bodies
* Pregnancy and lactation (female patients of child bearing age will receive a pregnancy test prior to study)
* Female volunteers without adequate contraception for the duration of the study Involvement in any other clinical trial during the course of this trial, nor within a period of 30 days prior to its beginning or 30 days after its completion
* Allergy against silicone
* Claustrophobia
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01347918
Study Brief:
Protocol Section:
NCT01347918