Developing Novel Microbiota-Targeted Therapies for Irritable Bowel Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

84 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-19

Study Completion Date

2017-02-08

Brief Summary

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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.

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Detailed Description

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Conditions

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Irritable Bowel Syndrome

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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IBS-C

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

No interventions assigned to this group

IBS-D

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

No interventions assigned to this group

Healthy subjects

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

No interventions assigned to this group

Healthy Controls

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

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of IBS-C or IBS-D
* Age 18 to 65

* 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

HEALTHY SUBJECTS:

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes