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Analyzing IBS to Identify Biomarkers and Microbiome Signatures

Sponsor
Mayo Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT02419963
Collaborator
(none)
26
Enrollment
1
Location
2
Arms
19.4
Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Microbiota from fecal samples from IBS-D patients, in combination with vitamin D supplementation added to our 3-D immunocompetent intestinal models will establish a high fidelity disease model to achieve our long-term goal to understand the relationship between gut microbiome, vitamin D levels, host gene expression and IBS-D symptoms that could ultimately be used as a testing platform for treatment and prevention.

Condition or Disease Intervention/Treatment Phase
  • Procedure: endoscopy for tissue biopsy
  • Other: Blood Sample
  • Other: Stool Sample
 N/A

Detailed Description

The pathophysiology of IBS is not well understood. Preliminary studies support IBS-D patients with varied microbiome fingerprints, vitamin D levels, and blood serotonin levels compared to non-IBS patients. The investigators have novel 3-D immunocompetent intestinal models to establish a new model of high fidelity disease to examine the relationship of IBS-D patients gut microbiome, with supplemental vitamin D levels, and the relationship of blood serotonin and vitamin D levels. IBS-D patients and healthy controls will be asked to provide a fecal sample, a biopsy sample of colonic tissue obtained during a clinically appropriate flexible sigmoidoscopy or colonoscopy, and a blood sample. There will be 1-2 office visits. One visit will last 30 minutes, the second visit no longer than 3 hours. This study is funded by a combined MAYO-Arizona State University seed grant. The samples will be analyzed at ASU. Our long-term goal is to understand the relationship between gut microbiome, vitamin D levels, host gene expression, serotonin levels, and IBS-D symptoms that could ultimately be used as a testing platform for treatment and prevention of this highly prevalent disorder.

Study Design

Study Type:
Interventional
Actual Enrollment :
26 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
A New Dimension in Modeling Irritable Bowel Syndrome (IBS) to Elucidate Novel Diagnostic Biomarkers and Microbiome Signatures
Study Start Date :
May 1, 2015
Actual Primary Completion Date :
Dec 12, 2016
Actual Study Completion Date :
Dec 12, 2016

Arms and Interventions

Arm Intervention/Treatment
Other: IBS-D patients

Subjects on this arm will have an endoscopy for tissue biopsy, and provide blood samples and stool samples.

Procedure: endoscopy for tissue biopsy
endoscopy to obtain tissue biopsy for analysis of biomarker status
Other Names:
  • Sigmoidoscopy

    • Other: Blood Sample
    Blood draw to evaluate serotonin and Vit D level.

    Other: Stool Sample
    Stool sample to evaluate microbiome fingerprint.
    Other: Healthy Controls

    Subjects on this arm will have an endoscopy for tissue biopsy, and provide blood samples and stool samples.

    Procedure: endoscopy for tissue biopsy
    endoscopy to obtain tissue biopsy for analysis of biomarker status
    Other Names:
  • Sigmoidoscopy

    • Other: Blood Sample
    Blood draw to evaluate serotonin and Vit D level.

    Other: Stool Sample
    Stool sample to evaluate microbiome fingerprint.

    Outcome Measures

    Primary Outcome Measures

    1. Serotonin level [Study Day 2]

      2 blood vials will be drawn during the flexible sigmoidoscopy or colonoscopy procedure, and serotonin levels will be drawn from one of these blood samples.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion criteria:
    IBS-D subjects:

    • Patients who fulfill IBS-D criteria, without causes of active inflammation.

    • active symptoms for at least 2 months

    • diagnosed at least 6 months prior to enrollment

    Healthy Control:
    • Healthy control patients should have no active infection or inflammation.
    Exclusion criteria:

    • does not meet inclusion criteria

    • will not participate in blood draw, stool sample donation, or endoscopy

    • history of acute illness within 3 months of testing

    • any fecal transplant history

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic in Arizona Scottsdale Arizona United States 85259

    Sponsors and Collaborators

    • Mayo Clinic

    Investigators

    • Principal Investigator: Amy Foxx-Orenstein, DO, Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Amy Foxx-Orenstein, PI, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT02419963
    Other Study ID Numbers:
    • 14-008799
    First Posted:
    Apr 17, 2015
    Last Update Posted:
    Jul 7, 2017
    Last Verified:
    Jul 1, 2017
    Keywords provided by Amy Foxx-Orenstein, PI, Mayo Clinic
    microbiome
    biomarkers
    Vitamin D
    Serotonin
    Additional relevant MeSH terms:
    Irritable Bowel Syndrome
    Syndrome
    Diarrhea

    Study Results

    No Results Posted as of Jul 7, 2017