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Analyzing IBS to Identify Biomarkers and Microbiome Signatures

NCT02419963 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2017-07-07

No results posted yet for this study

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.

Conditions

  • Diarrhoea Predominant Irritable Bowel Syndrome
  • IBS

Interventions

PROCEDURE

endoscopy for tissue biopsy

endoscopy to obtain tissue biopsy for analysis of biomarker status

OTHER

Blood Sample

Blood draw to evaluate serotonin and Vit D level.

OTHER

Stool Sample

Stool sample to evaluate microbiome fingerprint.

Sponsors & Collaborators

Principal Investigators

  • Amy Foxx-Orenstein, DO · Mayo Clinic

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2016-12-12
Completion
2016-12-12

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02419963 on ClinicalTrials.gov