Developing Novel Microbiota-Targeted Therapies for Irritable Bowel Syndrome

NCT02249169 | Completed

• 1 other identifier: 14-000305
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritable Bowel Syndrome

Keywords

IBS

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Motility Clinic, Clinical Research Unit, GI Department

You may qualify if:

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

You may not qualify if:

• 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:
• Age 18 to 65
• No clinical diagnosis of IBS-C or IBS-D
• 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)

Sponsors & Collaborators

• Mayo Clinic: lead
• University of Minnesota: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, serum, whole blood, stool, colonic mucosal tissue

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Purna C. Kashyap, M.B.B.S.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: September 19, 2014
• First Posted: September 25, 2014
• Study Start: September 19, 2014
• Primary Completion: February 8, 2017
• Study Completion: February 8, 2017
• Last Updated: August 17, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)