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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06066866
• Other study ID #: 71429
• Status: Not yet recruiting
• Start date: January 1, 2024
• Est. completion date: January 1, 2028

Study information

• Verified date: October 2023
• Source: Stanford University
• Contact: Sean P Spencer, MD,PhD
• Phone: (650) 736-5555
• Email: seanspen[@]stanford.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: January 1, 2028
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy
• IBS - Irritable Bowel Syndrome
• Inflammatory Bowel Diseases
• Irritable Bowel Syndrome

Intervention

Other:
• endoscopic sampling of luminal fluid
We will collect luminal fluid via endoscopic sampling

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ability to isolate live bacteria from 95% of samples	We aim to isolate live bacteria from 95% of samples	1-4 years
Secondary	Ability to measure quantitative Colony Forming Units (CFUs) in 90% of samples	We aim to measure quantitative Colony Forming Units (CFUs) in 90% of samples	1-4 years