Developing Novel Microbiota-Targeted Therapies for Irritable Bowel Syndrome

Mayo Clinic

Status: Completed

Conditions: Irritable Bowel Syndrome

Study type: Observational

Funder types: Other

Identifiers

NCT02249169

14-000305

Details and patient eligibility

About

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.

Enrollment: 84 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

84 participants in 4 patient groups

IBS-C

Description:

Patients with a clinical diagnosis of constipation-predominant irritable bowel syndrome

IBS-D

Description:

Patients with a clinical diagnosis of diarrhea-predominant irritable bowel syndrome

Healthy subjects

Description:

Subjects without a clinical diagnosis of IBS-C or IBS-D

Healthy Controls

Description:

Subject without a clinical diagnosis of IBS-C or IBS-D and who is either a first-degree relative of an IBS participant or is not genetically related but resides with the IBS participant