Analyzing IBS to Identify Biomarkers and Microbiome Signatures

NCT02419963 | Completed

• 1 other identifier: 14-008799
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Diarrhoea Predominant Irritable Bowel Syndrome; IBS

Keywords

microbiome; biomarkers; Vitamin D; Serotonin

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

endoscopy for tissue biopsy PROCEDURE

endoscopy to obtain tissue biopsy for analysis of biomarker status

Also known as: Sigmoidoscopy

Healthy Controls; IBS-D patients

Blood Sample OTHER

Blood draw to evaluate serotonin and Vit D level.

Healthy Controls; IBS-D patients

Stool Sample OTHER

Stool sample to evaluate microbiome fingerprint.

Healthy Controls; IBS-D patients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

MeSH Terms

Interventions

Endoscopy; Sigmoidoscopy; Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Colonoscopy; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Digestive System Surgical Procedures; Specimen Handling; Clinical Laboratory Techniques; Punctures; Investigative Techniques

Study Officials

• Amy Foxx-Orenstein, DO

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: January 30, 2015
• First Posted: April 17, 2015
• Study Start: May 1, 2015
• Primary Completion: December 12, 2016
• Study Completion: December 12, 2016
• Last Updated: July 7, 2017

Record last verified: 2017-07

Locations

US (1)