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 @ 1:02 AM
Ignite Modification Date:
2025-12-25 @ 1:02 AM
NCT ID:
NCT02793193
Eligibility Criteria:
Inclusion Criteria:
1. Male and female volunteers aged 18 to 50 years.
2. Signed informed consent. Written informed consent will need to be obtained from all participants, and the protocol will be submitted to the Ethics Board of the Medical School for approval,
3. Participant is willing to comply with the study restrictions.
4. Participant has been a non-smoker for at least 3 months.
5. Participants with body mass index 18-30.
Exclusion Criteria:
1. Participants are current smokers,
2. Participants have chronic allergies,
3. Participants are unwilling to discontinue the consumption of probiotic- and prebiotic-containing foods or potentially immune-enhancing dietary supplements (i.e. prebiotics, probiotics, Echinacea, fish oil and vitamin E (\>400 % of the RDA or .60 mg/d)),
4. Participants received an immune-suppressing intervention or have an immunosuppressive illness within the last year,
5. Participants have a psychiatric disorder (eg. depression, anxiety, dysthymia, panic disorder, disorder of mania or bipolar disorder, phobia, post-traumatic stress disorder, substance abuse, eating disorder) (only for recruiting healthy volunteers).
6. Participants received antibiotic therapy within the last 2 months of their study start date.
7. Participants have non-removable metal parts in the body such as: pacemaker, artificial heart valves, metal prostheses, implanted magnetic metal parts (screws), spiral, metal fragments / shrapnel, fixed braces, acupuncture needle, insulin pump, tattoos, eye shadow. Also, people with agoraphobia will be excluded.
8. Patients who do not meet the diagnosis criteria of IBS based on Rome I, II, or III (only for recruiting patients).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT02793193
Study Brief:
Protocol Section:
NCT02793193