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OpenTrials
Completed

NCT Number: NCT02249169

Developing Novel Microbiota-Targeted Therapies for Irritable Bowel Syndrome

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.

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • University of Minnesota

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Sep 25, 2014
Registry last updated
Aug 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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