Clinical trial NCT02249169: Developing Novel Microbiota-Targeted Therapies for Irritable Bowel Syndrome
Official title: Developing Novel Microbiota-Targeted Therapies for Irritable Bowel Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Irritable Bowel Syndrome
Keywords: IBS
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: University of Minnesota
First posted: 2014-09-25
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Motility Clinic, Clinical Research Unit, GI Department

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.


Eligibility 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

Primary outcomes:
measure: Change in gut microbiome in patients with IBS compared to healthy individuals measured over 6 months
timeFrame: baseline, 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Purna C. Kashyap, M.B.B.S.
role: PRINCIPAL_INVESTIGATOR
References: