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 @ 10:50 PM
Ignite Modification Date:
2025-12-24 @ 10:50 PM
NCT ID:
NCT02249169
Eligibility Criteria:
IBS-C and IBS-D SUBJECTS:
Inclusion Criteria:
* Clinical diagnosis of IBS-C or IBS-D
* Age 18 to 65
Exclusion Criteria:
* Prior history of abdominal surgeries (except appendectomy and cholecystectomy)
* Known diagnosis of inflammatory bowel disease, microscopic colitis, celiac disease or other inflammatory condition
* Antibiotic use within the past 4 weeks (they can be enrolled after a four-week washout period and subsequent use during the 6-month study duration does not exclude them)
* Bleeding risk or medications which may increase risk of bleeding for patients who agree to undergo flexible sigmoidoscopy
* Bowel preparation for colonoscopy within the past week
* Pregnancy or plans to become pregnant within the study time frame
* Vulnerable adults
* Age greater than or equal to 66
* Any other disease(s), condition(s) or habit(s) that would interfere with completion of the study, would increase risks of flexible sigmoidoscopy (for those opting for this), or in the judgment of the investigator would potentially interfere compliance to this study or would adversely affect study outcomes
HEALTHY SUBJECTS:
Inclusion Criteria:
* Age 18 to 65
* No clinical diagnosis of IBS-C or IBS-D
Exclusion Criteria:
* Prior history of abdominal surgeries (except appendectomy and cholecystectomy)
* Known diagnosis of inflammatory bowel disease, microscopic colitis, celiac disease or other inflammatory condition
* Antibiotic use within the past 4 weeks (they can be enrolled after a four-week washout period and subsequent use during the 6-month study duration does not exclude them)
* Bleeding risk or medications which may increase risk of bleeding for patients who agree to undergo flexible sigmoidoscopy
* Bowel preparation for colonoscopy within the past week
* Pregnancy or plans to become pregnant within the study time frame
* Vulnerable adults
* Age greater than or equal to 66
* Any other disease(s), condition(s) or habit(s) that would interfere with completion of the study, would increase risks of flexible sigmoidoscopy (for those opting for this), or in the judgment of the investigator would potentially interfere compliance to this study or would adversely affect study outcomes
* Clinical diagnosis of IBS-C or IBS-D
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02249169
Study Brief:
Protocol Section:
NCT02249169