Microbiome Sampling in GI Disease With a Focus on Small Intestinal Microbial Assessment
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Healthy
- Sponsor
- Stanford University
- Enrollment
- 150
- Primary Endpoint
- Ability to isolate live bacteria from 95% of samples
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
GI disorders are influenced by the gut microbiome. To date, sampling of the small intestine in GI disorders has been limited. The investigators plan to sample the small intestinal contents during endoscopy for research purposes.
Detailed Description
Current guidelines (AGA Clinical Practice Update, 2020) report the definition of SIBO as a clinical entity lacks precision and consistency; it is a term generally applied to a clinical disorder where symptoms, clinical signs, and/or laboratory abnormalities are attributed to changes in the numbers of bacteria or in the composition of the bacterial population in the small intestine. To date, there is unlimited knowledge regarding the diagnostic criterion which has been limited by nonspecific and nonsensitive testing such as breath tests. Breath tests have a limited use in patients with IBS-D who inherently have increased gut transit time rendering the testing invalid for accurately measuring small intestinal bacteria. Additionally, the relationship between SIBO and symptoms in patients without obvious risk factors (such as anatomical changes due to surgery) is unknown. The investigators study aims to investigate the microbial landscape of the small intestine in healthy patients and those with GI disease (suspected or diagnosed) undergoing an upper endoscopy by collecting an aspirate of patient small intestinal fluid and studying it.
Investigators
Sean Spencer
Instructor, Stanford Gastroenterology and Hepatology
Stanford University
Eligibility Criteria
Inclusion Criteria
- •Age \>18years
- •Patients seen at Stanford University Digestive Health Center who are scheduled for an upper endoscopy as part of their Standard Of Care
Exclusion Criteria
- •Children (under age 18years) Pregnant Women and Fetuses Neonates (0 - 28 days) Impaired Decision Making Capacity
Outcomes
Primary Outcomes
Ability to isolate live bacteria from 95% of samples
Time Frame: 1-4 years
We aim to isolate live bacteria from 95% of samples
Secondary Outcomes
- Ability to measure quantitative Colony Forming Units (CFUs) in 90% of samples(1-4 years)