A Non-Interventional Pilot Study to Explore the Role of Gut Flora in IBS

• Conditions: Irritable Bowel Syndrome Characterized by Constipation; Irritable Bowel Syndrome With Diarrhea; Irritable Bowel Syndrome With Constipation; Irritable Bowel; Irritable Bowel Syndrome Characterised by Alternating Bowel Habit; Irritable Bowel Syndrome; Irritable Bowel Syndrome Mixed; Irritable Bowel Syndrome Without Diarrhea; Irritable Bowel Syndrome Aggravated
• Interventions: Other: No intervention

• Registration Number: NCT04214470
• Lead Sponsor: ProgenaBiome

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.

Study Timeline

• Study First Submitted: 2019-12-27
• Study First Submitted QC: 2019-12-27
• Study First Posted: 2020-01-02
• Study Start: 2020-03-02
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-02
• Last Update Posted: 2021-09-05
• Primary Completion: 2023-03
• Study Completion: 2023-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. 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

2. Male or female of all ages

3. Diagnosis of IBS

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Irritable Bowel Syndrome Patients	No intervention	Patients with IBS.

Primary Outcome Measures

Name	Time	Method
Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing	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

Trial Locations

Locations (1)

ProgenaBiome; 🇺🇸 Ventura, California, United States