Skip to content

Microbiome Sampling in GI Disease With a Focus on Small Intestinal Microbial Assessment

Microbiome Sampling in GI Disease With a Focus on Small Intestinal Microbial Assessment

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06066866
Enrollment
150
Registered
2023-10-04
Start date
2024-01-01
Completion date
2028-01-01
Last updated
2023-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy, IBS - Irritable Bowel Syndrome, Inflammatory Bowel Diseases

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.

Interventions

OTHERendoscopic sampling of luminal fluid

We will collect luminal fluid via endoscopic sampling

Sponsors

Stanford University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Ability to isolate live bacteria from 95% of samples1-4 yearsWe aim to isolate live bacteria from 95% of samples

Secondary

MeasureTime frameDescription
Ability to measure quantitative Colony Forming Units (CFUs) in 90% of samples1-4 yearsWe aim to measure quantitative Colony Forming Units (CFUs) in 90% of samples

Contacts

Primary ContactSean P Spencer, MD,PhD
seanspen@stanford.edu(650) 736-5555

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026