Analyzing IBS to Identify Biomarkers and Microbiome Signa... | NCT02419963

Studies
Analyzing IBS to Identify Biomarkers and Microbiome Signatures

NCT02419963

Sponsor

Mayo Clinic

Status

Completed

Last Update Posted

Jul 7, 2017Actual

Enrollment

26Actual

Phase

Not Applicable

Conditions

Diarrhoea Predominant Irritable Bowel Syndrome
IBS

Interventions

endoscopy for tissue biopsy
Blood Sample
Stool Sample

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2015

Primary Completion Date

Dec 12, 2016Actual

Completion Date

Dec 12, 2016Actual

First Submitted Date

Jan 30, 2015

First Submission Date that Met QC Criteria

Apr 14, 2015

First Posted Date

Apr 17, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 5, 2017

Last Update Posted Date

Jul 7, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

26Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
IBS-D patients	Other	Subjects on this arm will have an endoscopy for tissue biopsy, and provide blood samples and stool samples.	Procedure: endoscopy for tissue biopsy Other: Blood Sample Other: Stool Sample
Healthy Controls	Other	Subjects on this arm will have an endoscopy for tissue biopsy, and provide blood samples and stool samples.	Procedure: endoscopy for tissue biopsy Other: Blood Sample Other: Stool Sample

Interventions

Name	Type	Description	Arm Group Labels	Other Names
endoscopy for tissue biopsy	Procedure	endoscopy to obtain tissue biopsy for analysis of biomarker status	Healthy Controls IBS-D patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Serotonin level	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.	Study Day 2

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Amy Foxx-Orenstein, DO	Mayo Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic in Arizona		Scottsdale	Arizona	85259	United States

Intervention Browse Module

MeSH Terms

ID	Term
D004724	Endoscopy
D012812	Sigmoidoscopy
D001800	Blood Specimen Collection

Ancestor Terms

ID	Term
D003949	Diagnostic Techniques, Surgical
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D019060	Minimally Invasive Surgical Procedures

Browse Leaves

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Browse Branches

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