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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06215222
Other study ID # IRB-62670
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 16, 2023
Est. completion date December 1, 2026

Study information

Verified date January 2024
Source Stanford University
Contact Sean Spencer, MD,PhD
Phone (650) 736-5555
Email seanspen@stanford.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

We will sample intestinal microbiota using a microbiome sampling capsule in Healthy, Irritable Bowel Syndrome (IBS), and Functional Gastrointestinal Disease.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date December 1, 2026
Est. primary completion date December 1, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - Males or females 18 years of age or older and 70 years of age or younger at the time of the first Screening Visit. - American Society of Anesthesiologists (ASA) Physical Status Classification System 1 or 2 (1-A normal healthy patient or 2-A patient with mild systemic disease) - For women of childbearing potential, negative urine pregnancy test within 7 days of Screening Visit. Willingness to use highly effective contraception during the entire study period (e.g.: implants, injectables, oral contraceptives, intra-uterine device or declared abstinence). - Subject is fluent in English and understands the study protocol and informed consent and is willing and able to comply with study requirements and sign the informed consent form. - Positive for at least one clinical symptoms consistent with SIBO and or IBS and or a Rome Diagnosis of functional GI disorder (Rome IV criteria) Exclusion Criteria: - History of any of the following: - Prior gastric or esophageal surgery, including lap banding or bariatric surgery - Bowel obstruction - Gastric outlet obstruction - Diverticulitis - Inflammatory bowel disease - Ileostomy or colostomy - Gastric or esophageal cancer - Achalasia - Esophageal diverticulum - Active Dysphagia or Odynophagia - Active medication use for any gastrointestinal conditions - Pregnancy or planned pregnancy within 30 days from Screening Visit, or breast-feeding - Any form of active substance abuse or dependence (including drug or alcohol abuse), unstable medical or psychiatric disorder, or any chronic condition susceptible, in the opinion of the investigator, to interfere with the conduct of the study

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Microbiota Sampling
We will sample the Saliva, Feces, and intestinal microbiome for genetic microbiome analysis and bacterial isolation

Locations

Country Name City State
United States Stanford Digestive Health Clinic Redwood City California

Sponsors (1)

Lead Sponsor Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Collection of 50ul of intestinal fluid from >90% of microbiome sampling capsules Collection of 50ul of intestinal fluid from microbiome sampling capsules 1-4 years
Secondary Isolation of liven bacteria from the intestinal fluid of >90% of microbiome sampling capsules Isolation of liven bacteria from the intestinal fluid of >90% of microbiome sampling capsules 1-4 years
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