Developing Novel Microbiota-Targeted Therapies for Irritable Bowel Syndrome

Completed

• Conditions: Irritable Bowel Syndrome

• Registration Number: NCT02249169
• Lead Sponsor: Mayo Clinic

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09-19
• Study First Submitted: 2014-09-19
• Study First Submitted QC: 2014-09-23
• Study First Posted: 2014-09-25
• Primary Completion: 2017-02-08
• Study Completion: 2017-02-08
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-15
• Last Update Posted: 2022-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in gut microbiome in patients with IBS compared to healthy individuals measured over 6 months	baseline, 6 months	Participants will provide a stool sample at baseline and at periodic intervals for 6 months to assess gut microbial composition.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States