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 @ 11:14 PM
Ignite Modification Date:
2025-12-24 @ 11:14 PM
NCT ID:
NCT02754869
Eligibility Criteria:
Inclusion Criteria:
ELIGIBILITY CRITERIA - CONTROL SUBJECTS DRUG STUDY:
* Adult (\>16 years)
* Body Mass Index within the range of (18---25)
ELIGIBILITY CRITERIA - DYSMOTILITY SUBJECTS DRUG STUDY:
* Adult patients (\>16 years) 2
* Dysmotility diagnosis including CIPO
* Body Mass Index within the range of (18---35)
ELIGIBILITY CRITERIA - REFERENCE RANGE STUDY (NORMAL PARTICIPANTS):
• Adult (\>16 years)
ELIGIBILITY CRITERIA - REFERENCE RANGE STUDY (DYSMOTILITY/IBS):
* Adult patients (\>16 years)
* Dysmotility, CIPO or IBS diagnosis
ELIGIBILITY CRITERIA - DYSMOTILITY REVERSIBILITY STUDY:
* Adult (\>16 years)
* Known small bowel Crohn's disease starting anti TNF alpha medication or undergoing endoscopic small bowel stricture dilatation.
Exclusion Criteria:
EXCLUSION CRITERIA - CONTROL SUBJECTS DRUG STUDY:
* Any contraindications to MRI scans (e.g. Implanted cardiac pacemaker, defibrillator device)
* Inability to give consent
* Treatment for any chronic illness
* Use of laxatives, anti---diarrhoeals or any drugs affecting GI motility (including NSAIDs) prohibited within one week of the scan.
* Cardiac symptoms (palpitations).
* Abnormal GI symptoms (eg. constipation, diarrhea, bloating, pain) as per the Rome III criteria for Irritable Bowel Syndrome
* Pregnancy
* Asthma EXCLUSION CRITERIA - DYSMOTILITY SUBJECTS DRUG STUDY: (18) Version 4.1
* Any contraindications to MRI scans (e.g. Implanted cardiac pacemaker, defibrillator device)
* Inability to give consent
* Use of laxatives, anti---diarrhoeals or any drugs affecting GI motility (including NSAIDs) prohibited within 1---3 days (or according to half life of drug) of the scan.
* Cardiac symptoms (palpitations).
* Pregnancy
* Asthma
EXCLUSION CRITERIA - REFERENCE RANGE STUDY (NORMAL PARTICIPANTS):
* Any contraindications to MRI scans (e.g. Implanted cardiac pacemaker, defibrillator device)
* Inability to give consent 3. Treatment for any chronic illness
* Use of laxatives, anti---diarrhoeals or any drugs affecting GI motility (including NSAIDs) prohibited within 1---3 days (or according to half life of drug) of the scan.
EXCLUSION CRITERIA - REFERENCE RANGE STUDY (DYSMOTILITY/IBS):
* Any contraindications to MRI scans (e.g. Implanted cardiac pacemaker, defibrillator device)
* Inability to give consent
* Use of laxatives, anti---diarrhoeals or any drugs affecting GI motility (including NSAIDs) prohibited within 1---3 days (or according to half life of drug) of the scan.
EXCLUSION CRITERIA - DYSMOTILITY REVERSIBILITY STUDY:
* Any contraindications to MRI scans (e.g. Implanted cardiac pacemaker, defibrillator device)
* Inability to give consent
* Use of laxatives, anti---diarrhoeals or any drugs affecting GI motility (including NSAIDs) prohibited within 1---3 days (or according to half life of drug) of the scan.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT02754869
Study Brief:
Protocol Section:
NCT02754869