A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Irritable Bowel Syndrome

ProgenaBiome1 site in 1 country100 target enrollmentMarch 2, 2020

ConditionsIrritable Bowel Irritable Bowel Syndrome Irritable Bowel Syndrome With Diarrhea Irritable Bowel Syndrome Mixed Irritable Bowel Syndrome With Constipation Irritable Bowel Syndrome Without Diarrhea Irritable Bowel Syndrome Aggravated Irritable Bowel Syndrome Characterized by Constipation Irritable Bowel Syndrome Characterised by Alternating Bowel Habit

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Irritable Bowel
Sponsor: ProgenaBiome
Enrollment: 100
Locations: 1
Primary Endpoint: Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing
Status: Withdrawn
Last Updated: 11 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.

Detailed Description

The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to IBS.

Registry

clinicaltrials.gov

Start Date

March 2, 2020

End Date

July 2030

Last Updated

11 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

ProgenaBiome

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study
•a. May be signed by parent or legal guardian in the case of minor or adult unable to provide consent
•Male or female of all ages
•Diagnosis of IBS

Exclusion Criteria

•Refusal to sign informed consent form
•History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
•Postoperative stoma, ostomy, or ileoanal pouch
•Participation in any experimental drug protocol within the past 12 weeks
•Treatment with total parenteral nutrition

Outcomes

Primary Outcomes

Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing

Time Frame: Three years

Relative abundance of bacterial classes within taxonomic phyla and, more broadly, within their domain will be analyzed by sequencing the gut microbiome. These data will then be categorized with diabetes mellitus