Developing Novel Microbiota-Targeted Therapies for Irrita... | NCT02249169

NCT02249169

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
University of Minnesota	OTHER

Oversight Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
IBS-C		Patients with a clinical diagnosis of constipation-predominant irritable bowel syndrome
IBS-D		Patients with a clinical diagnosis of diarrhea-predominant irritable bowel syndrome
Healthy subjects		Subjects without a clinical diagnosis of IBS-C or IBS-D
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

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

Eligibility Module

Eligibility Criteria

IBS-C and IBS-D SUBJECTS:

Inclusion Criteria:

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:

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

ID	Term
D003109	Colonic Diseases, Functional
D003108	Colonic Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases