Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06066866

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

endoscopic sampling of luminal fluid

Other

We will collect luminal fluid via endoscopic sampling

Primary outcomes

  1. 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

  1. Ability to measure quantitative Colony Forming Units (CFUs) in 90% of samples

    Time frame: 1-4 years

    We aim to measure quantitative Colony Forming Units (CFUs) in 90% of samples

Study contacts

Contact information is provided by the study sponsor or research team.

Sean P Spencer, MD,PhD

CONTACT

[email protected]

(650) 736-5555

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Oct 4, 2023
Registry last updated
Oct 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.