Developing Novel Microbiota-Targeted Therapies for Irritable Bowel Syndrome
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Irritable Bowel Syndrome (IBS) |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 2/7/2019 |
| Start Date: | May 2014 |
| End Date: | December 2019 |
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.
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.
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
We found this trial at
1
site
Rochester, Minnesota 55905
Principal Investigator: Purna C. Kashyap, M.B.B.S.
Phone: 507-538-1206
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