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:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2025-12-26 @ 11:49 AM
NCT ID:
NCT01517516
Eligibility Criteria:
Inclusion Criteria:
Men and women who meet the following criteria are eligible for inclusion in the study:
1. 18 to 55 years of age
2. ROME III criteria for IBS population
3. Willingness to participate in this study as evidenced by a signed, written informed consent form (ICF).
4. If female and of childbearing potential willingness to avoid pregnancy and practice adequate birth control (abstinence, oral contraception, intrauterine devices, implantable devices, depot contraceptives, or barrier method with spermicide) during the time of study enrollment.
5. If female, negative urine pregnancy tests at Screening Visit 1, and visit 2.
6. Right handed
7. Ambulatory outpatient (not depending exclusively on a wheelchair for mobility)
8. English is primary oral and written language.
9. Diagnosed with CVS
10. Diagnosed with IBD and currently not taking steroid therapy.
11. Diagnosed with vestibulodynia (a subgroup of vulvodynia)
12. Pre and peri menopausal only, post menopausal excluded.
Exclusion Criteria:
1. Evidence of structural abnormality of the gastrointestinal tract. Subjects with Functional GI conditions must be without 'red flags', that may indicate gastrointestinal disease. Exclusionary GI conditions include but are not limited to: gastrointestinal surgery (exceptions: IBD group, appendectomy, benign polypectomy, cholecystectomy)also esophagitis, celiac disease, gastrointestinal malignancy or obstruction; peptic, duodenal or gastric ulcer disease.
2. Clinical evidence of cardiovascular, respiratory, renal, hepatic, malignancy, hematologic, neurologic, psychiatric or any disease that the PI determines may interfere with safe participation in the study
3. Use of investigational drugs, products or devices within 28 days prior to screen and through study participation.
4. Subjects with current regular use of narcotics and or opioids. Use of medications/drugs that affect the central nervous system. TCA's, SSRI's or other antidepressants are allowed if on stable dose for 3 months or more.
5. Pregnancy or breast feeding
6. Subjects with extreme obesity (BMI \> 35%)
7. Subjects with metal implants, dental retainers, large tattoos (e.g. full arm or back) or claustrophobia; making MRI safety not possible.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT01517516
Study Brief:
Protocol Section:
NCT01517516