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

NCT ID: NCT06066866

Last Updated: 2023-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-01

Study Completion Date

2028-01-01

Brief Summary

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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

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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.

Conditions

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Healthy IBS - Irritable Bowel Syndrome Inflammatory Bowel Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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endoscopic sampling of luminal fluid

We will collect luminal fluid via endoscopic sampling

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Sean Spencer

Instructor, Stanford Gastroenterology and Hepatology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sean P Spencer, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Linda A Nguyen, MD

Role: STUDY_CHAIR

Stanford University

Central Contacts

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Sean P Spencer, MD,PhD

Role: CONTACT

(650) 736-5555

Other Identifiers

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71429

Identifier Type: -

Identifier Source: org_study_id

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