Functional Bloating, Functional Gastrointestinal Disorders, Healthy, IBS - Irritable Bowel Syndrome
Conditions
Keywords
microbiome, Small intestine
Brief summary
We will sample intestinal microbiota using a microbiome sampling capsule in Healthy, Irritable Bowel Syndrome (IBS), and Functional Gastrointestinal Disease.
Interventions
OTHERMicrobiota Sampling
We will sample the Saliva, Feces, and intestinal microbiome for genetic microbiome analysis and bacterial isolation
Sponsors
Stanford University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Collection of 50ul of intestinal fluid from >90% of microbiome sampling capsules | 1-4 years | Collection of 50ul of intestinal fluid from microbiome sampling capsules |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Isolation of liven bacteria from the intestinal fluid of >90% of microbiome sampling capsules | 1-4 years | Isolation of liven bacteria from the intestinal fluid of \>90% of microbiome sampling capsules |
Countries
United States
Contacts
Primary ContactSean Spencer, MD,PhD
Outcome results
None listed