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 @ 4:43 PM
Ignite Modification Date:
2025-12-24 @ 4:43 PM
NCT ID:
NCT03462966
Eligibility Criteria:
Inclusion Criteria:
* Male or female subjects aged 18-75 years old inclusive
* Meet Rome IV criteria for IBS-D or IBS-M
* Subjects should report urgency with bowel movement at least once a week
* If subjects are ≥50 years old, a colonoscopy must have been completed within the past 5 years
* Subjects are capable of understanding the requirements of the study, are willing to comply with all the study procedures, and are willing to attend all study visits.
* Agree to use an acceptable method of contraception throughout their participation in the study. Acceptable methods of contraception include: double barrier methods (condom with spermicidal jelly or a diaphragm with spermicide); hormonal methods (e. g. oral contraceptives, patches or medroxyprogesterone acetate); or an intrauterine device (IUD) with a documented failure rate of less than 1% per year. Abstinence or partner(s) with a vasectomy may be considered an acceptable method of contraception at the discretion of the investigator.
* All subjects will provide Institutional Review Board (IRB)-approved informed written consent prior to beginning any study-related activities
NOTE: Female subjects who have been surgically sterilized (e.g. hysterectomy or bilateral tubal ligation) or who are postmenopausal (total cessation of menses for \>1 year) will not be considered "females of childbearing potential".
Exclusion Criteria:
* Treatment with antibiotics or Xifaxan in the last two months
* Subjects with history of intestinal surgery (except appendectomy or cholecystectomy)
* Subjects with known pelvic floor dysfunction
* Pregnancy
* Nursing mothers
* Poorly controlled/uncontrolled significant medical condition that would interfere with study procedures
* History of bowel obstruction
* History of celiac disease
* History of inflammatory bowel disease
* Cirrhosis
* IBS-C/chronic idiopathic constipation
* Diabetes
* History of anorectal radiation/surgery
* History of prostatitis
* Known allergy or hypersensitivity to rifaximin or rifamycin
* Current treatment with eluxadoline or opiates
NOTE: Development of any of the exclusion criteria during the study will be considered a basis for subject discontinuation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03462966
Study Brief:
Protocol Section:
NCT03462966