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

Sponsor

Stanford University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06066866

Collaborator

(none)

150

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy IBS - Irritable Bowel Syndrome Inflammatory Bowel Diseases	Other: endoscopic sampling of luminal fluid

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

150 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2024

Anticipated Primary Completion Date :

Jan 1, 2026

Anticipated Study Completion Date :

Jan 1, 2028

Outcome Measures

Primary Outcome Measures

Ability to isolate live bacteria from 95% of samples [1-4 years]
We aim to isolate live bacteria from 95% of samples

Secondary Outcome Measures

Ability to measure quantitative Colony Forming Units (CFUs) in 90% of samples [1-4 years]
We aim to measure quantitative Colony Forming Units (CFUs) in 90% of samples

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Stanford University

Investigators

Principal Investigator: Sean P Spencer, MD,PhD, Stanford University
Study Chair: Linda A Nguyen, MD, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sean Spencer, Instructor, Stanford Gastroenterology and Hepatology, Stanford University

ClinicalTrials.gov Identifier:

NCT06066866

Other Study ID Numbers:

71429

First Posted:

Oct 4, 2023

Last Update Posted:

Oct 6, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Inflammatory Bowel Diseases

Irritable Bowel Syndrome

Phenobarbital

Study Results

No Results Posted as of Oct 6, 2023