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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02249169
Other study ID # 14-000305
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 19, 2014
Est. completion date February 8, 2017

Study information

Verified date August 2022
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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 will be used to determine whether temporal changes in gut microbial taxonomy and metabolism are associated with changes in symptom severity in IBS, and if targeted dietary interventions, including prebiotics, can reverse or moderate these changes.


Recruitment information / eligibility

Status Completed
Enrollment 84
Est. completion date February 8, 2017
Est. primary completion date February 8, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Mayo Clinic Rochester Minnesota

Sponsors (2)

Lead Sponsor Collaborator
Mayo Clinic University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in gut microbiome in patients with IBS compared to healthy individuals measured over 6 months Participants will provide a stool sample at baseline and at periodic intervals for 6 months to assess gut microbial composition. baseline, 6 months
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