Analyzing IBS to Identify Biomarkers and Microbiome Signatures

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2016-12-12

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Diarrhoea Predominant Irritable Bowel Syndrome IBS

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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IBS-D patients

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

Group Type OTHER

endoscopy for tissue biopsy

Intervention Type PROCEDURE

endoscopy to obtain tissue biopsy for analysis of biomarker status

Blood Sample

Intervention Type OTHER

Blood draw to evaluate serotonin and Vit D level.

Stool Sample

Intervention Type OTHER

Stool sample to evaluate microbiome fingerprint.

Healthy Controls

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

Group Type OTHER

endoscopy for tissue biopsy

Intervention Type PROCEDURE

endoscopy to obtain tissue biopsy for analysis of biomarker status

Blood Sample

Intervention Type OTHER

Blood draw to evaluate serotonin and Vit D level.

Stool Sample

Intervention Type OTHER

Stool sample to evaluate microbiome fingerprint.

Interventions

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endoscopy for tissue biopsy

endoscopy to obtain tissue biopsy for analysis of biomarker status

Intervention Type PROCEDURE

Blood Sample

Blood draw to evaluate serotonin and Vit D level.

Intervention Type OTHER

Stool Sample

Stool sample to evaluate microbiome fingerprint.

Intervention Type OTHER

Other Intervention Names

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Sigmoidoscopy

Eligibility Criteria

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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.

* will not participate in blood draw, stool sample donation, or endoscopy
* history of acute illness within 3 months of testing
* any fecal transplant history

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes