Developing Novel Microbiota-Targeted Therapies for Irritable Bowel Syndrome

August 15, 2022 updated by: Purna C. Kashyap, MBBS, Mayo Clinic
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

84

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Motility Clinic, Clinical Research Unit, GI Department

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in gut microbiome in patients with IBS compared to healthy individuals measured over 6 months
Time Frame: baseline, 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

University of Minnesota

Investigators

  • Principal Investigator: Purna C. Kashyap, M.B.B.S., Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 19, 2014

Primary Completion (Actual)

February 8, 2017

Study Completion (Actual)

February 8, 2017

Study Registration Dates

First Submitted

September 19, 2014

First Submitted That Met QC Criteria

September 23, 2014

First Posted (Estimate)

September 25, 2014

Study Record Updates

Last Update Posted (Actual)

August 17, 2022

Last Update Submitted That Met QC Criteria

August 15, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-000305

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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