Status:
COMPLETED
Developing Novel Microbiota-Targeted Therapies for Irritable Bowel Syndrome
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
University of Minnesota
Conditions:
Irritable Bowel Syndrome
Eligibility:
All Genders
18-65 years
Brief Summary
This longitudinal study is being done to understand mechanisms underlying development of irritable bowel syndrome (IBS) and the role of the gut bacteria in development of symptoms. This information wi...
Eligibility Criteria
Inclusion
- IBS-C and IBS-D SUBJECTS:
- Clinical diagnosis of IBS-C or IBS-D
- Age 18 to 65
Exclusion
- 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
Key Trial Info
Start Date :
September 19 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 8 2017
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT02249169
Start Date
September 19 2014
End Date
February 8 2017
Last Update
August 17 2022
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905