NCT06066866

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
20mo left

Started Jan 2024

Longer than P75 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress59%
Jan 2024Jan 2028

First Submitted

Initial submission to the registry

September 27, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 4, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Expected
Last Updated

October 6, 2023

Status Verified

October 1, 2023

Enrollment Period

2 years

First QC Date

September 27, 2023

Last Update Submit

October 4, 2023

Conditions

HealthyIBS - Irritable Bowel SyndromeInflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (1)

  • Ability to isolate live bacteria from 95% of samples

    We aim to isolate live bacteria from 95% of samples

    1-4 years

Secondary Outcomes (1)

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

    1-4 years

Interventions

endoscopic sampling of luminal fluidOTHER

We will collect luminal fluid via endoscopic sampling

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients seen at Stanford University Digestive Health Center who are scheduled for an upper endoscopy as part of their Standard Of Care

You may qualify if:

  • Age \>18years
  • Patients seen at Stanford University Digestive Health Center who are scheduled for an upper endoscopy as part of their Standard Of Care

You may not qualify if:

  • Children (under age 18years) Pregnant Women and Fetuses Neonates (0 - 28 days) Impaired Decision Making Capacity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Irritable Bowel SyndromeInflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesGastroenteritis

Study Officials

  • Sean P Spencer, MD,PhD

    Stanford University

    PRINCIPAL INVESTIGATOR

  • Linda A Nguyen, MD

    Stanford University

    STUDY CHAIR

Central Study Contacts

Sean P Spencer, MD,PhD

CONTACT

(650) 736-5555seanspen@stanford.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Instructor, Stanford Gastroenterology and Hepatology

Study Record Dates

First Submitted

September 27, 2023

First Posted

October 4, 2023

Study Start

January 1, 2024

Primary Completion

January 1, 2026

Study Completion (Estimated)

January 1, 2028

Last Updated

October 6, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share